INDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(668)-11/Pur Dated:4.10.11 Dear Sirs, We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. S.No. | Description of the material ‘Qty 7 Dynamic Pass Box 1 Detailed Specifications as per Annexure enclosed ‘You are requested to Turnish your quotation wih Ineratue’vatalogue ete. superscribing quotation for Dynamic Pass Box duly mailed by courier/speed post so as to reach on or before 14.11.2011 upto2.30 PM to the address of the Director (Attn. Stores & Purchase Officer, Indian Institute of Integrative Medicine Canal Road, Jamimu-180001and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives ofthe bidders, if any desire to atend Tender Opening. Prices should he quoted on FOR HIM Jammu Discount: Institutional Discount, if any allowed should be mentioned specifically Taxes and Levies: Should be mentioned inthe offer. J&K Entry Tax: Entry Tax may also be taken into account while quoting, Presently Entry Tax is 13.5% Excise Duty: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate ean be issued accordingly Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid til time of supply ‘6% payment against supply of material at site (IM Jamin). 20% after installation and successful commissioning of equipment ‘Soscial Terms & Conditions ender needs to submit thei client Fist and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith All venders should fill URS of machineries given along with the tender document, without proper filling of URS, tenders will not be accepted. Validity of rates: A certificate of rates i also tobe attached by the supplier with the quotation tha dhe rates quoted to TIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Insttate or Govt. Organization, ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after murual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are ro be specified clearly. Right of acceptance / rejection of tender is reserved with Director, {LIM, Jam, Note: - In case the parties want to quote as Indian agents of foreign suppliers, the following terms their offers, 1. FOB/CIF Price. 2. Country of origin, :Shipping details, 4, Agency commission if any. Other terms & Conditions as per Annexure enclosed ty be specified in clear terms in Yours faithfully, Stores & Purchase OfficerVendor Should specify their comments as* USER REQUIREMENT SPECIFICATIONS (URS) DYNAMIC PASS BOX DOCUMENT NO. HIM/URS/28 TECHNICAL SPECIFICATIONS FOR DYNAMIC PASS BOX es” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 11 About The Project: Indian Insttate of Integrative Medicine (IIIM) isa national Insitute of the Council of & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species), Now IITM wishes to construct a state ‘of ant eGMP compliant pilot herbal extraetion, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical herbal drugs and reference standards, drugs for purpose J D Pharma Consultants Scope: ‘This user requirement specification will be recognized as an integral part ofthe procurement ‘agreement with the selected equipment vendor. The equipment supplier or vendor will abide by 12 tific al trials) manufactured under GMP conditions. For this engaged as a project consultant 13 the information and conditions set forth by this document as wel as the standard purchasing teem and conditions of the HIM Purpose: ‘This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for dynamic pass box. The machine will he used for transfer of material from ‘one area to another area 14 Equipment General Description: ‘The dynamic pass box will be operated independently of other equipment and systems and will be located in a designated operating area 15 ‘Guidelines for equipment: ‘The equipment should comply with following guidelines(standard: Schedule M,WHO &USFDA Guidelines Specifications Remarks 2.0 Operational Requirement 2.1 Capaci Internal Di ize: External dimension: 850 mm(W)x680 mm(D)x1250 mm(H) ension: 610 mm(W)x610 mm(D)x1250 mm(H) 2.2 Process control features: Pressure differential 2.3 Safety Features: Following safety features required: Emergeney stop funetion Closure ofall rotating part Wherever possible, warning symbols should be provided 24 Power failure & recovery: Machine settings should not get disturbed due to power failure. Machine should not estat without human intervention, 2.5 Cleai All contact parts should be easily be considered, ig requirement: ismantled and cleanable, for contact part CIP shall For Information For Information For Information For Information For Information2.6 Instrumentation: Following instrumentation is required for process control: ‘Type of control Instrumentation Pressure differential Pressure gauges Specific requirement: Class of cleanliness of air as par ISO 14644: ISO 5 Primary filter : coarse filter(10/15 micron) Door interlocking arrangement View panels Blower centrifugal Magnehelic gauges Should Validated with following test: Air velocity DOP test Particle count Air flow pattern Specifications Remarks 3.0 Technical requirement: Utilities consumption: A: Electricity: (Specify by supplier) Vendor should specify weight, size & heat given of machine. Industrial plug, cable i in scope of vendor 4.0 Documentation: List of all Documents (Not limited to this) to be supplied along with equipment. Document shall be supplied in hard copy & electronic editable version in English language. Sr. | Document to be Supplied ~ TQiy |) Remarks | Design and operational qualification Cpt Operation manual 4 Maintenance manual, - - S| Spare parts manual oo - 6 ing drawings. a [S_| Calibration certificates 9 Warranty / Guarantee 12__| Installation manual _ - 13; Technical literature, data sheets and equipment | catalogues _ if DO. iQ, O@ documents 15 ration Report of all sensors, controllers, PLC, ans tters, indicators ete. _ 16 | Test certificates of ali material of construction Constraints: 5.1 Material of construction: 304 Time lines: Response to URS & submission of quotation: as mentioned aboveDelivery of machine: within 4 weeks of finalization of order Submission of detail design specification &electrical , mechanical drawing: within 2 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT IQ & OQ protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT (Site acceptance test) After delivery & successful installation. 6.2 Support: ing program for operator & technical staff has to be included in offer. Glossary: [5] User Requirement Specification, in Institute of Integrati medi +__| Design Qualification i 1H nstallation Qualification Operational Qualification | | Performance Qualification Stainless Steel | Material of Construction ; Horse Power Rotation Per Minute | jj Current Goods Manufacturing Practices :__| Piping and instrumentation diagram T Variable frequency drive Programmable logic controller Human Machine Interface _ 16. UPS (| Uninterrupted Power Supply iINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2569023, 2569019, No. 2(668)-11/Pur Dated:4.10.11 Sul Dear Sirs, urchase of Capsule Polishing Machi ‘We are interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No, and date of opening of Tender in one envelop, ‘S.No. | Description of the material Qty 1 ‘Capsule Polishing Machine 1 or Detailed Specifications as per Annexure enclosed ‘You are requested to furnish your quotation with Ierature’ eatalogue ele, superscribing quotation Tor Automatic Capsule Filling Machine and Capsule Polishing Machine” duly mailed by courier’speed post so as to reach on or before 9.11.2011 upto2.30 PM. to the address ofthe Director (Attn. Stores & Purchase Office), Indian Institute of Integrative Medicine Canal Read, Jammu-18000 Land the same will be opened ‘on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, if any desir to attend Tender Opening. Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, ifany allowed should be mentioned speci ‘Taxes and Levies: Should be mentioned in the offer. ‘J&K Entry Tas: Entry Tax may also be taken into account while quoting. Presently Entry Tax is 13.5% Excise Duty: We are exempted for payment of Fxeise duty and necessary Duty Exemption Certificate ean be issued accordingly Delivery: Within the lead-time isthe essence ofthe order and isto be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantce of equivalent amount valid till ime of supply {60% payment against supply of material at site (ITM Jammu). 20% afler installation and sucoessiul commissioning of equipment ally 2 & Co Vender needs to submit their client lst and at least three successful installations and operation cemiicate from end users. All Prices quoted should be FOR TIM Jammu, including packing and forwarding charges & prescribed in specified format attached herewith All venders should fill URS of machineries given along with the tender document, without proper filling of URS, tenders will not be accepted, Validity of rates: A certificate of rates i also to be attached by the supplier with the quotation thatthe rates quoted to IIMS, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Institue oF Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly, Right of aeeptance / rejection of tender is reserved with Director, LIM, Jammu, ‘Note: - In ease the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers. 1. FOB/CIF Price. 2. Country of origin, 3. Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) CAPSULE POLISHING MACHINE DOCUMENT NO. HIM/URS/25 EQUIPMENT ID PC-25 TABLE OF CONTENTS Particulars Page no. INTRODUCTION 1.1_| ABOUT THE PROJECT 3 12 | SCOPE 3 13 | PURPOSE 3 14__ | EQUIPMENT GENERAL DESCRIPTION 3 1.5 | GUIDELINE FOR EQUIPMENT 3 2.__ | OPERATIONAT. REQUIREMENT 2.1_| CAPACITY q 2.2 _| PROCESS PARAMETER CONTROL 4 2.3 _| SAFETY FEATURES 4 2.4 | POWER FAILURE & RECOVERY 4 2.5_| CLEANING REQUIREMENT 4 2.6 _| INSTRUMENTATION 4 2.7 _| SPECIFIC REQUIREMENT. as 3._ | TECHNICAL REQUIREMENT 3 DOCUMENTATION 56 CONSTRAINTS MATERIAL OF CONSTRUCTION 6 ‘MILE STONE & TIMELINES 8 6. | LIFE CYCLE 6.1__| INSPECTION & TESTING 7 6.2 | SUPPORT 7 3 a ‘Vendor Should specify their comments as*Yes” or “No” in remarks column, Specifications Remarks 1.0 INTRODUCTION: 1.6 About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific ‘& Industrial Research (CSIR) of India, with primary focus of research on drug discovery from. For Information natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state ‘of art cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions For this purpose J D Pharma Consultants is engaged as a project consultant. 17 Scope: ‘This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor, The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the IM. For Information 1.8. Purpose: “This document was generated under the authority ofthe IIM forthe purpose of specifying the For Information"user requirement for capsule polishing machine. The machine shall be used for polishing of capsules, 1.9 Equipment General Description: ‘The eapsule polishing machine will be operated independently of other equipment and systems and willbe located ina designated operating area For Information 1.10Guidelines for equipment: “The equipment should comply with following guidelines/standar: Schedule M,WHO &USFDA Guidelines For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 500 capsule/min 2.2 Process control features: 2. Variable frequency drive of main motor for speed adjustment 2.3 Safety Features: Following safety features required: 4. Emergeney stop funetion 5. Closure of al rotating part 6. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery: Machine settings should not get disturbed due to power failure. Machine should not restart \without human intervention, 2.5 Cleaning requirement: All contact parts should be easily dismantled and cleanable, for contact part CIP shall be considered. 2.6 Instrumentation: Following instrumentation is required for process control: ‘Type of control Instrumentation Speed of machine VED. Specific requirement: Preferred make of motor: Crompton/Kirloskar The polishing machine should be able to polish 500 capsules per minute There should be separation of product area and mechanically lubricated area. All product contact part should be $S316L. The machine should have safety guard and interlocking, Machine should be able to accommodate size of capsule from 00 to 5 Should equipped with capsule conveying system for transfer of filled capsule from filling machine to polishing machine Dust extraction system is required for collecting loose powder from capsule Damaged capsule sorter is required for separation of diametrically defective filled capsule. Should be online process without operator intervention Machine should equipped with control panel All contact gaskets and other material should be FDA grade. Complete set of change part should be provided. Specifications Remarks Technical requireme: Utilities consumption: A: Electricit (Specify by supplier)(Specify by supplier) . (Specify by supplier) Vendor should specify weight, size & heat given of machine. Vendor shall provide special tools for maintenance of equipment Industrial plug, cable, air tube is in scope of vendor Suitable for Interface with SCADA system RS232 LAN . Arrangement for printing with necessary parameters (Optional) Documentation: List of all Documents (Not limited to this) to be supplied along with equipment. Document I be supplied in hard copy & electronic editable version in English language. Sr. ‘Document to be supplied Qty Remarks, Design and operational qualification SATIFAT procedures [ Operation manual Spare parts manual | All engineering List of instruments Calibration certificates Warranty / Guarantee 10 L mn 12 Civil foundation drawings — rf [13 | Pre installation requirements sets | (14 Installation requirements - 2 sets (15 Installation manual | 2sets_ 16 | Technical literature, data sheets and equipment 2sets catalogues a 17 DQ, 1Q, 0Q documents | Deets 18 Calibration Report of all sensors, controllers, PLC, 2 sets transmitters, indicators ete. monitoring system, Constraints: 5.1 Material of construction: All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery of machine: within 2 month of finalization of order Submission of detail design specification &electrical , mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT (Site acceptance test) After delivery & successful installation. 6.2 Support:Training program for operator & technical stafT has to be included in offer. i: [User Requirement Specification. | Indian Institute of Integrative medicines {Design Qualification Installation Qualification | Operational Qualification Performance Qualification | Stainless Steel Material of Construction Horse Power | Rotation Per Minute Current Goods Manufacturing |__| Practices Piping and instrumentation diagram | Variable frequency drive | Programmable logic controller Human Machine Interface Uninterrupted Power SupplyINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones 0191-2569000, 256900, to 10 (11 Lines) Telefax: 2569028, 2569019, No. 2(673)-11/Pur Dated:4.10.11 ‘We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. S.No. | Description of the material ‘Qty 1 Tablet Hardness and thickness Tester 2 Detailed Specifications as per Annexure enclosed ‘You are requested to furnish your quotation with literature! catalogue ete. superscribing quotation for Tablet Hardness and thickness Tester” duly mailed by courir!speed post so as to reach on or before 14.11.2011 upto2.30 PM to the address of the Director (Attn. Stores & Purchase Officer), Indian Institute of Integrative Medicine Canal Road, Jammu-18000".and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, if any desire 1o attend Tender Opening. Prices should he quoted on FOR HIM Jammu Discount: Institutional Discount, if any allowed should be mentioned speci ‘Faxes and Levies: Should be mentioned inthe offer. J&K Entry Tax: Entry Tax may also be taken into account while quot Eacise Duty: We ae exempted for payment of Excise dty and necessary Duty Exeaplion Certificate can be sated accordingly Delivery: Within the lead-time isthe essence ofthe order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount vali ill tine of supply (60% payment against supply of material at site (HIM Jammu). 20% afer installation and successful commissioning of equipment ‘Special Terms & Conditions Vender needs to submit their client lst and at least three successful installations and operation certificate from end users. Al P sould be FOR 11M Jamma, including packing and forwarding charges & prescribed in specified format attached herewith All venders should fill URS of machineries given along with the tender document, without proper filling of URS, tenders will not be accepted Validity of rates: 4 certificate of rate i also to be attached by the supplier with the quotation tht the rates quoted to TIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Institute of Govt. Organization, ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of IIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of acceptance / rejection of tender is reserved with Director, ILIM, Jammu, Note: - In case the parties want fo quote as Indian agents of foreign supplicrs, the following ferms may be speci their offers. 1. FOB/CIF Price. 2, Country of origin, Other terms & Conditions as per Annexure enclosed +s quoted ping details, 4. Ageney e mission if any. Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) TABLET HARDNESS & THICKNESS TESTER DOCUMENT NO IIIM/URS-39 EQUIPMENT ID-L-09 TABLE OF CONTENTS No. Particulars Page no. INTRODUCTION .1__ | ABOUT THE PROJECT 3 12 | SCOPE. 3 13__| PURPOSE 3 1.4 | EQUIPMENT GENERAL DESCRIPTION, 3 ‘OPERATIONAL REQUIREMENT ‘SPECIFIC FEATURES q SAFETY FEATURES q POWER FAILURE & RECOVERY 4 DOCUMENTATION 5 ‘CONSTRAINTS MILE STONE & TIMELINES 6 ._| LIFE CYCLE 3.1__ | INSPECTION & TESTING 6 5.2__ | SUPPORT 6 6. 6 Vendor Should specify their comments as “Yes” or “No” in remarks column Specifications Remarks 1,0 INTRODUCTION: 1.1 About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from For Information natural products (medicinal plants and microbial species), Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical! herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant 1.2 Scope: For Information This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the ITIM. 1.3 Purpose: For Information This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for a thickness & hardness test apparatus,1.4 Equipment General Description: ‘The equipment is used for determination of hardness & thickness, diameter & length of tablet as par pharmacopoeia monograph For Information Specifications Remarks 2.0 Operational Requirement 2 Specific features: 1. Thickness testing in range of 2-10 mm with accuracy of less then 0.02 mm 2. Hardn 3. Diameter testing in range of 1-10 mm with aecuracy of less then 0.02 mm 4. Automatic analysis for sample up to 200 numbers 5. Digital display for set parameter & result 6, Interchangble measuring unit from Newton to kilopond 2 8 9. esting in range of 2-500 Newton with accuracy of | Newton Equipment should be USP/EP & GLP compiled Printer connectivity (Optional) Material of construction of housing should be SS 304 & diameter range 2.2 Safety Features: Following safety features required: 1. Earthing for equipment 2. Closure of all rotating part 23 Power failure & recovery: Equipment settings should not get disturbed due to power failure, Data should restored after recovery of power fuilure, able to maintain log recotd of power failure Specifications Documentation: | shall be supplied in hard copy st of all Documents (Not limited to this) to be supplied along with equipment. Document | nglish language. ‘Sr. | Document to be supplied Qty Remarks No. - . 1 [ Installation, operational __ [2 sets 2 Operation manual 1 Deets 3 Maintenance manual - [2sets 4 Spare parts manual __ 2 sets _ 3 (Cali ~ [2 sets” (6 | Warranty / Guarantee _ i 2sets | 7 ist of all components with referencing [ 8 Technical literature, data sheets and equipment 2 sets | catalogues a 9 __| Test certificates of ali material of construction ~[ dsets 10 “Test Certificates of software used in machine control. 2 sets | monitoring system Constraints: Time lines: Response to URS & submission of quotation: Within 2 weeks Submission of detail design specification & drawing: within 3 weeks of order finalization.‘Supply of instruments: within 2 month of order finalization 1Q & 0Q protocol: With delivery 3.0 Life Cycle 5.1 Inspection & Testing: Vendor shall also perform SAT(Site acceptance test) After delivery & successful installation. 5.2 Support Training program for operator & technical staff has to be included in offer. Glossary: 1 User Requirement Specification 2. - - Tndian Institute of Integrative medicines 3. DQ. - |_| Design Qualification i 4. 1Q |: | Installation Qualification 5.00 | Operational Qualification [6 [PQ - + [Performance Qualification | 7. SS - - | Stainless Steel 8 | Material of Construction Good Laboratory Practices [| Programmable logic controllerINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2569023, 2569019, No. 2(675)-11/Pur Dated:4.10.11 Sul Dear Sirs, ‘urchase of Karl Fisher Apparatus ‘We ae interested to purchase the below mentioned items for our research work, You are requested to send us the quotes long with the terms _& eonditions giving our tender reference No. and date of opening of Tender in one envelop. ‘S.No. | Description of the material Qty 1 Karl Fisher Apparatus oO Detailed Specifications as per Annexure enclosed ‘You are requested to furnish your quotation with Iferature” catalogue ee, superscribing quotation Tor..Karl Fisher Apparatus™ duly mailed by courier/speed post so as to reach on or before 14.11.2011 upto2.30 PM. to the address ofthe Director (Att. Stores & Purchase Officer, Indian Institute of Integrative Medicine Canal Road, Jament-180001and the same will be opened on the same day’at 3.30PM. in the presence of the authorized representatives ofthe bidders, if any desire to attend Tender Opening. Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, ifany allowed should be mentioned specifically ‘Taxes and Levies: Should be mentioned in the offer. ‘J&K Entry Tas: Entry Tax may also be taken into account while quoting. Presently Entry Tax is 13.5%, Excise Duty: We are exempted for payment of Fxeise duty and necessary Duty Exemption Certifiate can be issued accordingly Delivery: Within the lead-time isthe essence ofthe order and isto be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantce of equivalent amount valid rll ime of supply {60% payment against supply of material at site (TM Jammu). 20% afler installation nd sucoessiul commissioning of equipment 2 & Co Vender needs to submit their client list and atleast three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jammu, including packing and forwarding charges & prescribed in specified format attached herewith All venders should fill URS of machineries given along with the tender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rate i also to be attached by the supplier with the quotation thatthe rates quoted to HEM, Jammu is not higher than the rates quoted to any other CSIR Laboratory’Insttute or Govt, Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified cleerly. Right of aeeptance / rejection of tender is reserved with Director, ILIM, Jammu, ‘Note: - In ease the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers. 1. FOB/CIF Price. 2. Country of origin, 3. Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) KARL FISHER APPARATUS DOCUMENT NO. IIIM/URS/41 EQUIPMENT ID NO. LI-11 TABLE OF CONTENTS No. Particulars Page no. 5,__| INTRODUCTION L1__| ABOUT THE PROJECT. 3 12 | SCOPE. 3 13__| PURPOSE 3 1.4 | EQUIPMENT GENERAL DESCRIPTION, 3 ‘OPERATIONAL REQUIREMENT ‘SPECIFIC FEATURES q SAFETY FEATURES q POWER FAILURE & RECOVERY 4 DOCUMENTATION 5 ‘CONSTRAINTS MILE STONE & TIMELINES 6 ._| LIFE CYCLE 3.1__ | INSPECTION & TESTING 6 5.2__ | SUPPORT 6 6. 6 Vendor Should specify their comments as*Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 1.5 About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species), Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical’ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant For Information 1.6 Scopi This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor, The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the IIIM. For Information 1.7 Purpose: This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for a kat fisher apparatus For Information 1.8 Equipment General Description: The equipment is used for termination of water using karl fisher method as par respective For Information‘product or pharmacopoeia monograph specification Specifications Remarks 2.0 Operational Requirement 2.1Specific features: 11. Calculation of water content in percent oF ppm 12. Titration time 1-2 minute or near standard time 13. Instrument should be integrated with PC & printed 14, Instrument should be capable to generate daily summary report & report ofeach test 15. Instrument should be GLP compliance 2.2 Safety Features: Following safety features require: 3. Earthing for equipment 4. Closure ofall rotating part 2.3Power failure & recovery: Equipment settings should not get disturbed due to power failure. Data should restored after recovery of power failure Specifications Documentation: "List of all Documents (Not limited to this) tobe supplied along with equipment, Document | shall be supplied in hard copy & electronic editable version in English language. ir. | Document to be supplied TQty | Remarks Lo : 4 i 1 Installation, operationalqualification 2 sets _ 2 3___| Maintenance manual 4 Spare parts manual_ - 5 ration certificates& method i 6 T List of all components with referencing | 2 sets 8 | Technical literature, data sheets and equipment 2 sets catalogues ee . Test certificates of all material of construction | 2sets, 10 ‘Test Certificates of software used in machine control / 2 sets monitoring system Constraints: Time lines: Response to URS & submission of quotation: Within 2 weeks Submission of detail design specification & drawing: within 3 weeks of order finalization. Supply of instruments: within 2 month of order finalization 1Q.& OQ protocol: With deliver 5.0 Life Cycle 5.1 Inspection & Testing: Vendor shall also perform SAT(Site acceptance test) After delivery & successful installation, 5.2 Support: Training program for operator & technical staf has to be included in offer. Glossary:Design Qualification Hnstallation Qualification | Operational Qualification {Performance Qualification Stainless Steel | | Material of Construction | Good Laboratory Practices | Programmable logic controllerINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2569028, 2569019, No. 2(677)-11/Pur Dated:4.10.11 ‘Suh.: Purchase ofMelting Point Apparat Dear Sirs, ‘We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. S.No. | Description of the material ‘Qty 1 ‘Melting Point Apparatus o Detailed Specifications as per Annexure enclosed ‘You are requested to Tumnish your quotation with Iaeratur’ catalogue ee, superscribing quotation Tor Melting Point Apparatus” duly mailed by courier spoed post so as to reach on or before 14.11.2011 upto2.30 PM. to the address ofthe Director (Attn. Stores & Purchase Officer, Indian Institute of Integrative Medicine Canal Road, Janina-1S0001.and the same will be opened on the same day at 3.30PM. in the presence ofthe authorized representatives of the bidders, if any desire to atend Tender Opening. Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, fany allowed should be mentioned specifically ould be mentioned ia the offer. ‘Tax may also be taken into account while Entry Tax is 13.5% iy: We are exempted for payment of Excise duty and necessary Duty Exemption Certifieare ean be issued accordingly. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20%% advance payment against Bank Guarantee of equivalent amount valid til time of supply ‘60% payment against supply of material at site (IM Jammu), 20% after installation and sucoessiul commissioning of equipment ‘Special Terms & Conditions Vender needs to submit their client Fist and at should be FOR THM Jam st three successil installations and operation certificate from end users. All Prices quoted including packing and forwarding charges & prescribed in specified format attached herewith Al venders should fill URS of machineries piven along withthe tender document, without proper filling of URS, tenders will not be accepted, Validity of rates: A certificate of rates is also to be attached by the supplier with the quotation that the rates quoted to HIEM, Jammu isnot higher than the rates quoted to any other CSIR Laboratory/Insttute or Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should he unambiguous and Tens and Conditions are to he specified clearly. Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, ‘Note: - In ease the parties want to quote as Indian agents of foreign supplier, the following terms may be specific their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed clear terms in Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) MELTING POINT APPARATUS DOCUMENT NO. HIM/URS-44 EQUIPMENT NO. L1-14 TABLE OF CONTENTS S.No. Particulars Page no. 9. [INTRODUCTION 1.1_| ABOUT THE PROJECT 3 12 [SCOPE 3 13 | PURPOSE 3 14 | EQUIPMENT GENERAL DESCRIPTION 3 10. | OPERATIONAL REQUIREMENT 2.1_| SPECIFIC FEATURES a 2.2 _| SAFETY FEATURES q 2.3__| POWER FAILURE & RECOVERY q 11.__| DOCUMENTATION 5 12,__| CONSTRAINTS ‘MILE STONE & TIMELINES 5 5._| LIFE CYCLE 3.2___| SUPPORT 5 6.__| GLOSSARY 6 Specifications Remarks 1.0 INTRODUCTION: 1.9 About The Project Indian Institute of Integrative Medicine (I1IM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now HIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this, purpose J D Pharma Consultants is engaged as a project consultant For Information 1.10Scope: This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor, The equipment supplier or vendor will abice by the information and conditions set forth by this document as well as the standard purchasing, term and conditions of the IM. For Information 1.11 Purpose: This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for a melting point apparatus For Information 1.12Equipment General Descrip' ‘The equipment is used for determination of melting point For InformationSpecifications Remarks 2.0 Operational Requirement 2.1Specific features: 16. Meting point apparatus temperature range should be from ambient to 300°C 17, Parameter like temperature & heating rate should be displayed 18. Rate of heating should be controllable 2.2 Safety Features: Following safety features required: 5. Earthing for equipment 6. Closure of rotating part 2.3Power failure & recovery: Equipment settings should not get disturbed due to power failure Specifications Documentation: List of all Documents (Not limited to this) tobe supplied along with equipment. Document shall be supplied in hard copy & electronic editable version in English language. Sr, Document to be supplied Qty | Remarks No. - - 1 | Operation manual — - - [2 sets 2 ‘Maintenance manual SS 2 sets 3 Calibration cei sets 4 Warranty / Guarantee sels 5 List of all components with referencing - 2 sets © | Technical literature, data sheets and equipment 2sets catalogues Constraints: Time lines: Response to URS & submission of quotation: Within 2 weeks Submission of detail design specification & drawing: within 3 weeks of order finalization. Supply of instruments: within 2 month of order finalization 5.0 Life Cycle 5.1 Support: ‘Training program for operator & technical stafThas tobe included in offer _[: TUser Requirement Specification. | ~_[. {Indian Institute of Integrative medicines | Design Qualification ‘Unstallation Qualification Operational Qualification | =| Performance Qualification {Stainless Steel | Material of Construction j ' Good Laboratory Practices Programmable logic controllerINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(678)-11/Pur Dated:4.10.11 ‘Suh.: Purchase of Colony Counter Dear Sirs, ‘We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along sith the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. S.No. | Description of the material Qty 1 Colony Counter Or Detailed Specifications as per Annexure enclosed ‘You are requested to Turnish your quotation with Ineratur’ catalogue ete, superscribing quotation Tor Coloay Counter duly mailed by courier speed post so as to reach on or before 14.11.2011 upto2.30 PM. to the address of the Director (Attn. Stores & Purchase Officen), Indian Institute of Integrative Medicine Canal Road, Janina-180001.and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives ofthe bidders, if any desire to atend Tender Opening. Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, fay allowed should be mentioned specifically ould be mentioned ia the offer. ‘Tax may also be taken into account while 1 iy: We are exempted for payment of Excise duty and necessary Duty Exemption Certifieate ean be issued accordingly. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid till time of supply ‘60% payment against supply of material at sit (IM Jammu). 20% after installation and sucoessiul commissioning of equipment ‘Special Terms & Conditions \Vender needs to submit their client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith, Al venders should fill URS of machineries given along withthe tender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rates is also tobe attached by the supplier with the quotation that the rates quoted to IITM, Jamo is not higher than the rates quoted to any other CSIR Laboratory/Insttute or Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should he unambiguous and Terms and Conditions are to he specified clearly, Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, Note: «In case the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) TECHNICAL SPECIFICATIONS FOR COLONY COUNTER DOCUMENT NO HIM/URS/45 Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 1.13About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from For Information natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state ‘of art cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant 1.14Scope: For Information This user requirement specification will be recognized as an integral part ofthe procurement ‘agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions ofthe IM 1.15 Purpose: For Information ‘This document was generated under the authority of the IIM for the purpose of specifying the user requirement for an colony counter. 1.16Equipment General Description: For Information ‘The equipment shall be used for analysis of microbial count Specifications Remarks 2.0 Operational Requirement 2.1Specific features: 19, Automatic microbial count with 5 digit display, microprocessor based 20, Push button for reset of equipment 21. Magni 22. Appropriate lighting arrangement for round or square dish up to 100 mm size, area sd lens of | 10 7 mm with level adjustment illuminated by peripheral metal reflector 23. Equipment should integrated with PC & printer 24. Equipment should comply with GLP requirement 2.2 Safety Features: Following safety features required: 7. Warning symbols should be provided (If required) 8. Earthing for equipment 2.3Power failure & recovery: Equipment settings should not get disturbed due to power failure. Loss of data due to power failure should not occurred Specifications Remarks Documentation: List of all Documents (Not limited to this) tobe supplied along with equipment. Documentpli ard copy : Document to be supplied Remarks [Spare parts manual _ Calibration certificates Warranty / Guarantee List of all componen i mn requil [installation requirements 10 Technical literature, da catalogues { 11____ Test certificates of all material of construction 2 sets 12 | ‘Test Certificates of software used in machine control? | 2 sets monitoring system Constrain ‘Time lines: Response to URS & submission of quotation: as mentioned above Submission of detail design specification & drawing: within 2 weeks of order finalization. Delivery: 4 weeks 1Q & OQ protocol: With delivery 5.0 Life Cycle 5.1 Inspection & Testing: Vendor shall also perform SAT(Site a installation, 5.2 Support: ling program for operator & technical ceptance test) After delivery & successful AT has to be included in offer [| User Requirement ication. |_| User Requirement Specification, _[2 indian Institute of Integrative medicines __i_| Design Qualification [| Operational Qualification Performance Qualification Stainless Steel Material of Construction Good Laboratory Practices | | Programmable logic controllerINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2869028, 2569019, No. 2(681)-11/Pur Dated:4.10.11 Sub: Pus Dear Sirs, tase ofWeighing Balance 500k We are interested to purchase the below mentioned items for our research work. You ate requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. ‘S.No. | Description of the material Qty T Weighing Balance S00kg oO Detailed Specifications as per Annexure enclosed ‘You are requested Wo Turnish your quotation with Iieratue”eatalogae ote, superscribing quotation for" Weighing Balaneo™ duly mailed by courier spoed post so as to reach on or before 14.11.2011 upto2.30 PM. to the address ofthe Director (Attn. Stores & Purchase Officer), Indian Institute of Integrative Medicine Canal Road, Janina-180001.and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, if any desire to attend Tender Opening. Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, fany allowed should be mentioned specifically ould be mentioned ia the offer. ax may also be taken inte account while y Entry Tax is 13.5% iy: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate can be issued accordingly. Delivery: Within the lead-time is the essence of te order and i to be specifically mentioned inthe order. Payment: 20%% advance payment against Bank Guarantee of equivalent amount valid tll time of supply ‘60% payment against supply of material at site (IM Jammu). 20% after installation and sucoessful commissioning of equipment ‘Special Terms & Conditions \Vender needs to submit thei client list and at least three successful installa should be FOR THM Jamn and operation certificate from end users. All Prices quoted including packing and forwarding charges & prescribed in specified format attached herewith Al venders should fill URS of machineries given along withthe tender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rates is also to be attached by the supplier with the quotation that the rates quoted to TIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Institute or Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should he unambiguous and Terms and Conditions are to he specified clearly, Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, ‘Note: - In case the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) WEIGHING BALANCE 500KG DOCUMENT NO. IIIM/URS/51 EQUIPMENT ID PC-21 TABLE OF CONTENTS S.No. Particulars Page no. 13._ | INTRODUCTION 1.1 [ABOUT THE PROJECT 3 12 | SCOPE 3 13 | PURPOSE 3 14 | EQUIPMENT GENERAL DESCRIPTION 3 14,__| OPERATIONAL REQUIREMENT 2.1_| CAPACITY q 2.2_| SPECIFIC FEATURES a 2.3 _| SAFETY FEATURES a 2.4 _| POWER FAILURE & RECOVERY q 15._| DOCUMENTATION 3 16._| CONSTRAINTS MILE STONE & TIMELINES 6 a CYCLE 31 iSPECTION & TESTING 6 5.2___| SUPPORT 6 6. __| GLOSSARY @ Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 1.17 About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from For Information natural produets (medicinal plants and mierobial species). Now HIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical! herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions, For this, purpose J D Pharma Consultants is engaged as a project consultant 1.18Scope: For Information This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well asthe standard purchasing term and conditions ofthe 1M 1.19 Purpose: For Information This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for a weighing balance. 1.20Equipment General Description: For Information The equipment is used for weighing of materialSpecifications Remarks 2.0 Operational Requirement 2.1Specific features: 25. ‘Type: floor scale 26. Maxinum weighing capacity: $00 ke 27. Accuracy: +/- 50g 28. Readability: 50/100 gm 29. MOC: platform SS 304 ,Body & Indicator SS 304 30. Balance should be capable of counting, tarring, totalizing, percentage weighing, toggling between grossinet value 31. Arrangement for connectivity with printer 32. Provision for leveling 33. Over load & low battery indicator 34. Auto power off 2.2 Safety Features: Following safety features required: 9. Earthing for equipment 10. Closure of balance 2.3Power failure & recover, Equipment settings should not get disturbed due to power failure. Specifications Documentation: List of all Documents (Not limited to this) tobe supplied along with equipment. Document | shall be sup py sh language. ! Sr. ‘Document to be supplied Qty Remarks No, _ [1 Tastallation, operationalqualification | Teets 2 Operatic ao 2 sets [3___[ Maintenance manual “TP sets (4! Spare parts manual _ - _ | 2 sets. {5 Calibration certificates — | 2sets (6 | Warranty / Guarantee - | 2 sets 7___ List of all components with referencing | 2sets 8 ‘Technical literature, data sheets and equipment Tsets catalogues 3.0 Constraints: 3.1 Time lines: 1, Response to URS & submission of quotation: Within 2 weeks 2. Submission of detail design specification & drawing: within 3 weeks of order finalization, 4 Delivery : within two month of order finalization IQ & 00 protocol: With delivery 5.0 Life Cycle 5.1 Inspection & Testing: Vendor shall also perform SAT(Site acceptance test) After delivery & successful installation, 5.2 Support: ‘Training program for operator & technical stafFhas to be included in offer Glossary:Design Qualification Hnstallation Qualification | Operational Qualification {Performance Qualification Stainless Steel | | Material of Construction | Good Laboratory Practices | Programmable logic controllerINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(685)-11/Pur Dated:4.10.11 ile Filling and vealing machine We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envslop. S.No. | Description of the material Qty 1 ‘Semi-Automatic Capsule Filling and Sealing Machine Or Detailed Specifications as per Annexure enclosed ‘You are requested to Tumnish your quotation with Lieratue” catalogue ete, sperseribing quotation for Semi-Automatic Capsule ling aad sealing Machine" duly mailed by courierspeed post so as to reach on or hefore 7.11.2011 upto2.30 PM to the address of the Director (Attn, Stores & Purchase Officer, Indian Institue of Integrative Medicine Canal Road, Janvn-180001.and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, fany desire to attend Tender Opening Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, fany allowed should be mentioned specifically ould be mentioned ia the offer. ‘Tax may also be taken into account while quoting. Presently Entry Tay is 13.5% iy: We are exempted for payment of Exciso duty and necessary Duty Exemption Certificate ean b Delivery: Within the lead-time is the essence of te order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid tll time of supply ‘60% payment against supply of material at site (IM Jammu). 20% after installation and suceessiul commissioning of equipment issued accordingly. ‘Special Terms & Conditions Vender needs to submit their client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jammu, including packing and forwarding charges & prescribed in specified format attached herewith Al venders should fill URS of machineries given along withthe tender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rates is also to be attached by the supplier with the quotation that the rates quoted to TIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Institue oF Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should he unambiguous and Terms and Conditions are to he specified clearly, Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, ‘Note: - In case the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) SEMI AUTOMATIC CAPSULE FILLING MACHI DOCUMENT NO IIIM/URS/ 24 EQUIPMENT ID NO. PT-24 TABLE OF CONTENTS SNo. Particulars Page no. 17._ | INTRODUCTION L.L_| ABOUT THE PROJECT 3 12 | SCOPE 3 13 | PURPOSE 3 14__| EQUIPMENT GENERAL DESCRIPTION 3 1S | GUIDELINE FOR EQUIPMEN 3 18._| OPERATIONAL REQUIREMENT 2.1_| CAPACITY 4 2.2_| PROCESS PARAMETER CONTROL 4 2.3_| SAFETY FEATURES 4 2.4 _| POWER FAILURE & RECOVERY 4 2.5 _| CLEANING REQUIREMENT 4 2.6 _| INSTRUMENTATION 7 2.7 _| SPECIFIC REQUIREMENT 4 19.__| TECHNICAL REQUIREMENT @ 20, | DOCUMENTATION oF 21.__| CONSTRAINTS MATERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 6._| LIFE CYCLE 6.1 _| INSPECTION & TESTING i 62 | SUPPORT 7 is GLOSSARY 8 Vendor Should specify their comments as*Yes” or “No” in remarks column. Specifications Remarks 1.0 INTRODUCTION: T.21About The Project Indian Institute of Integré \ve Medicine (IIIM) is national Institute of the Council of Scientific ‘& Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state ‘of art cGMP compliant plot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose JD Pharma Consultants is engaged as a project consultant. For Information 1.22Seope: This user requirement specification will be recognized as an integral part of the procurement For Information‘agreoment with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions ofthe IM 1.23 Purpose: ‘This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for semi Automatic capsule filling machine. The machine shall be used for filling & sealing of capsules, For Information 1.24Equipment General Description: ‘The semi automatic capsule filling & scaling machine will be operated independently of other ‘equipment and systems and will be located in a designated operating area. For Information 1.25Guidelines for equipment: ‘The equipment should comply with following guidelines/standard: Schedule M,WHO For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 500 capsule/min 2.2 Process control features: 3, Variable frequeney drive of main motor for speed adjustment of augar& filling table 2.3 Safety Features: Following safety features required: 1. Emergeney stop function 2. Closure of al rotating part 3. Wherever possible, warning symbols should be provided 24 Power failure & recovery: Machine settings should not get disturbed due to power failure, Machine should not restart without human intervention 2.5 Cleaning requirement: All contact parts should be easily dismantled and cleanable, for contact part CIP shall be considered 2.6 Instrumentation: Following instrumentation is required for process control ‘Type of control Instrumentation ‘Speed of machine VED Number of capsule filled capsule Counter Specific requirement: Preferred make of PLC: Mitsubshi /Siemens Preferred make of motor: Crompton/Kirloskar The filling machine should be able to fill 500 capsules per minute There should be separation of product area and mechanically lubricated area. All product contact part should be $S316L. ‘The filling machine should have safety guard and interlocking The weight variation is +/-3.% Machine should be able to accommodate size of capsule from 00 to 5 with high filling accuracy Powder hopper to be provided with level control arrangement for continuous feeding of powder Control panel of machine should equipped with PLC with appropriate control features MOC of loading ring: Magnesium alloy Suitable capacity vacuum pump with machine All contact gaskets and other material should be FDA grade.Complete set of change part should be provided. Interface with machine through HMI. All size capsule change part required with machine Automatic empty capsule separation after loading. Should have synchronization with online capsule polishing machine Specifications Remarks 10.0 Technical requirement: 4. Utilities consumption: A Electricity (Specify by supplier) B: Air Pressure = (Specify by supplier) Vacuums... SOLLLID G peel by supplier) 5. Vendor should specify sight, size & heat given of machine 6. Vendor shall provide special tools for maintenance of equipment 7. Industral plug, cable, ar tube isin scope of vendor 8. System security shall be provided to access the operation system HMI) Documentation: shall be supplied in hard copy & electronic editable version in English language. Sr. | Document to be supplied Qty | Remarks No. | - - 1 Design and operational qualification 2 sets 2 SATIFAT procedures _ 3___ Operation manual 4 jaintenance manual, type of lubricants, lubrication | instruction - [ Spa nual 6 All engineering drawings, P&ID, As built drawings T___| List ofinstruments 8 Calibration certificates 9 | Warranty / Guarantee 10 | List of all components with referencing 11 P& Tprocess flow diagrams 112 Civil foundation drawings - 113 Pre installation requirements 14 __ | Installation requirements | catalogues i 17} DQ, 1Q, 0Q documents. _ _ 18 | Calibration Report of all sensors, controllers, PLC, transmitters, indicators ete. [19 Test certificates of ail material of construction List of all Documents (Not limited to this) to be supplied along with equipment. Document Constraints: 5.1 Material of construction: All contact parts: SS 316L with mirror fi All non contact parts: S$ 304 with mat finish Gasket/seal/O ring: Food grade Time lines: Response to URS & submission of quotation: Within 2 weeksDelivery of machine: within 2 month of finalization of order ‘Submission of detail design specification &electrical , mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT IQ & OQ protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT (Site acceptance test) After delivery & successful installation. 6.2 Support: Training program for operator & technical staf has to be included in offer. Glos: [User Requirement Specification. | Indian Institute of Integrative | medicines Design Qualification | | Installation Qualification Operational Qualification | | Performance Qualification "Stainless Steel Material of Construction | Horse Power i Rotation Per Minute | | Current Goods Manufacturing Practices 12. P& ID - Piping and instrumentation diagram | Variable frequency drive | Programmable logic controller Human Machine Interface Uninterrupted Power Supply lINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2569023, 2569019, No. 2(686)-11/Pur Dated:4.10.11 Sub: Pus Dear Sirs, iase ofTablet De Dusting Machine We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envslop. S.No. | Description of the material Qty 1 Tablet De Dusting Machine Or Detailed Specifications as per Annexure enclosed ‘You are requested to Tumnish your quotation with Iieratue” catalogue ete, superscribing quotation for Tablet De Dusting Machine > duly mailed by courier'speed post so ast reach on or before 9.11.2011 upto2.30 PM to the address of the Director (Attn, Stores & Purchase Officer), Indian Institute of Integrative Medicine Canal Road, Jamsmu-180001-and the same will be opened on the same day at 3.30PM in the presence ‘of the authorized representatives ofthe bidders, if any desire to attend Tender Open Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, fany allowed should be mentioned specifically ould be mentioned ia the offer. ‘Tax may also be taken into account while iy: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate can be issued accordingly. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned inthe order. Payment: 20%% advance payment against Bank Guarantee of equivalent amount valid til time of supply ‘60% payment against supply of material at site (IM Jammu). 20% after installation and sucoessiul commissioning of equipment ‘Special Terms & Conditions ‘ender needs to submit thei client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith Al venders should fill URS of machineries given along withthe tender document, without proper filing oF URS, tenders will ot be accepted Validity of rates: A certificate of rates is also tobe attached by the supplier with the quotation that the rates quoted to TIM, Jammu is not higher than the rates quoted to any other CSIR LaboratoryInstitute or Govt, Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, ‘Note: - In ease the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed clear terms in Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) TABLET DEDUSTING MACHINE DOCUMENT NO. IIIM/URS/09 EQUIPMENT ID NO. PT-09 TABLE OF CONTENTS S.No. Particulars Page no. 22. | INTRODUCTION LLL ABOUT THE PROJECT 3 12 | SCOPE 3 13__| PURPOSE 3 1.4__| EQUIPMENT GENERAL DESCRIPTION 3 LS | GUIDELINE FOR EQUIPMENT 3 23._| OPERATIONAL REQUIREMENT 2.1_| CAPACITY 4 2.2 _| PROCESS PARAMETER CONTROL 4 2.3_| SAFETY FE: 4 2.4 | POWER FAILURE & RECOVERY + 2.5_| CLEANING REQUIREMENT + 2.6 _| INPROCESS CONTROL 4 2.7_| INSTRUMENTATION 7 2.8 _| SPECIFIC REQUIREMENT 4 24, | TECHNICAL REQUIREMENT 3 25._| DOCUMENTATION 36 26._| CONSTRAINTS MATERIAL OF CONSTRUCTION é ‘MILE STONE & TIMELINES. 6 6._| LIFE CYCLE 6.1_[ INSPECTION & TESTING 6 6.2 _| SUPPORT 7 ‘GLOSSARY 7 Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 1.26About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from For Information natural products (medicinal plants and microbial species), Now IIIM wishes to construct a state of art cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their produets (botanical herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this, purpose J D Pharma Consultants is engaged as a project consultant,1.27Scope: This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the IIIM. For Information 1.28 Purpose: ‘This document was generated under the authority of the IIM for the purpose of specifying the user requitement for a Tablet de dusting machine, The system shall be used for de dusting of | tablet. For Information 1.29Equipment General Description: The tablet de dusting machine will be operated independently of other equipment and systems and willbe located in a designated operating area, The machine is used for de dusting of tablet with help of vibration, compressed air & vacuum dust extraction, For Information 1.30Guidelines for equipment: ‘The equipment should comply with following guidelines/standard: Schedule M,WHO For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: output 5000-2,50,000 Tablet/hr 2.2 Process control features: Following parameters shall be controlled by machine: 1. Vibration conteal 2.3 Safety Features: Following safety features required: 1, Emergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 4. Appropriate failure detection 24 Power failure & recovery: In the event of a power failure, The system will stop in a safe mode automatically, or other major utility and will require operator intervention to re-start.After regain of, power the equipment should start from the step it stopped. 2.5 Cleaning requirement: All contact parts should be easily dismantled and cleanable, cleaning shall be done manually 2.6 In process control: Not applicable 2.7 Instrumentation: Following instrumentation is required for process control Purpose Instrumentation Vibration Vibration controller 2.8 Specific requirement: 1. Preferred make of motor: Crompton/ Kirloskar 2. inlet height: 27-35 inch, outlet height: 47-55 inch Arrangement for metal detection system 3. Wheel arrangement for movement of equipment 4. Noise level below 80 db at a distance of | mt. from equipment.3.0 Technical requirement: 9. Utilities consumption: A: Electricity: (Specify by supplier) 10. Vendor should specify weight, size &capacity cheat given(lnside room) of machine. 11. Vendor shall provide special tools for maintenance of equipment 12, Industrial plug, cable, air tube is in scope of vendor Documentation List of all Documents (Not limited to this) to be supplied along with equipment, Document hall be supplied in hard copy & soft copy. Document to be supplied Ope - 4 ‘Maintenance manual, type of lubricants, lubi instruction, food grade certifi bri Spare parts manual 11 process flow diagrams (12 Civil foundation drawings (if applicable | | 13 Pre installation requirements - | 14 | Installation requi _ 15 Installation manual_ - i 16 Technical literature, data sheets and equipment 2 sets 7 [Di - 18 transmitters, indicators ete. 19 ‘Test certificates of all material of construction Constraints 5.1 Material of construction: All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade All welds should be ground finished Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Two month of order finalization Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With deliver 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation. 6.2 Support ing program for operator & technical staff has to be included in offerGlossary: i [URS 2. TIM User Requirement Specification. | ‘Indian Institute of Integrative | medicines Design Qualification “Installation Qualification Operational Qualification | Performance Qualification Stainless Steel | Material of Construction Horse Power | Rotation Per Minute Current Goods Manufacturing Practices Piping and instrumentation diagram :_| Variable frequency drive | Programmable logic controller Human Machine Interface Li [Uninterrupted Power SupplyINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2569028, 2569019, No. 2(687)-11/Pur Dated:4.10.11 Sub.: Purchase ofAuto Coater Dear Sirs, We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envslop. ‘S.No. | Description of the material Qty T ‘Auto Coater oO Detailed Specifications as per Annexure enclosed ‘You are requested to Tumnish your quotation with Ineratur’ catalogue te, superscribing quotation Tor Auto Coate?” duly mailed by couriespoed post so as t reach on or before 9.11.2011 upto2.30 PM to the address ofthe Director (Attn. Stores & Purchase Officer), Indian Inttute of Integrative Medicine Canal Road, Jammu-180001.and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, iF any deste to attend Tender Opening. Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, ifany allowed should be mentioned specifically ould be mentioned ia the offer. ‘Tax may also be taken into account while Entry Tax is 13.5% iy: We are exempted for payment of Excise duty and necessary Duty Exemption Cerificate can be issued accordingly, Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned inthe order. Payment: 20%% advance payment against Bank Guarantee of equivalent amount valid tll time of supply ‘60% payment against supply of material at site (IM Jammu). 20% after installation and sucoessiul commissioning of equipment ‘Special Terms & Conditions \Vender needs to submit their client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith, Al venders should fill URS of machineries given along withthe tender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rates is also tobe attached by the supplier with the quotation that the rates quoted to IITM, Jamo is not higher than the rates quoted to any other CSIR Laboratory/Insttute or Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should he unambiguous and Terms and Conditions are to he specified clearly, Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, Note: «In case the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) AUTO COATER DOCUMENT NO. ILIM/URS/10 EQUIPMENT ID PT-10 TABLE OF CONTENTS No. Particulars Page no. 27.__| INTRODUCTION LL | ABOUT THE PROJECT 3 12 | SCOPE. 3 13__| PURPOSE 3 1.4 | EQUIPMENT GENERAL DESCRIPTION, 3 15 IIDELINE FOR EQUIPMENT 3 28.__| OPERATIONAL REQUIREMENT. 2.1 [CAPACITY q 2.2 _| PROCESS PARAMETER CONTROL q 2.3_| SAFETY FEATURI 7 2.4 _| POWER FAILURE & RECOVERY a 2.5_| CLEANING REQUIREMENT a 2.6_ | INPROCESS CONTROL 5 2.7_ | INSTRUMENTATION 3 2.8 _| SPECIFIC REQUIREMENT 3 29,__| TECHNICAL REQUIREMENT 6 30.__[ DOCUMENTATION oF 31._| CONSTRAINTS, MATERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES. 7 6,_| LIFE CYCLE G.1__| INSPECTION & TESTING 3 62 | SUPPORT z GLOSSARY co) Vendor Should specify their comments as*Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 1.31 About The Project Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species), Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical! herbal deugs and reference standards, drugs for clinical tials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant For Information 1.32Scope: ‘This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by For InformationThe information and conditions set forth by this document as well asthe standard purchasing term and conditions of the IIIM. 1.33 Purpose: ‘This document was generated under the authority of the IIM for the purpose of specifying the user requirement for a coating system, The system shall be used to perform a coating process of tablets. For Information 1.34Equipment General Description: ‘The coating system will be operated independently of other equipment and systems and will be located in a designated operating area, Tablet Coating system shall use for both film & sugar ‘coating with change over. A typical coating Process involves the following steps 1. Charging of compressed tablet in pan 2. Afier reaching a preset exhaust temperature indicating tablet bed is warm. 3. Spray Solution to Tablets 4, Afi reaching desired weight gain on tablets 5. Coated, dried tablet unload in container The unit should consist of following 1. PLC to control batch operation. 2, AHU with HEPA filter supply, exhaust system For Information 1.35Guidelines for equipment: “The equipment should comply with following guidelines’ Schedule M,WHO For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: Pan size 28° with interchangeable bowl of 20° & 18° 2.2 Process control features: Following parameters shall be controlled by machine: 2. Solution Spray time 3. Solution spray rate 4. Speed of pan 5, Inlet air temperature 6. Atomizing pressure 7. Tablet bed temperature Notification to operator for operational control: 35, Deviation in temp. of inlet air 36, Coating solution pump failure 37. Low Atomizing air pressure 2.3 Safety Features: Following safety features required! 1. Emergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 4, Instruments should be supplied with serubber 5. Equipment should be flame proof construction 24 Power failure & recovery: In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, air or other major utility and will require operator intervention to re-start. After regain of power the equipment should start from the step itstopped 2.5 Cleaning requirement: All contact parts should be easily dismantled and cleanable, WIP system shall be considered for pan, charging discharging chute, spray gun & nozzles. 2.6 In process control: Manual sampling for inprocess sampling shall be considered 2.7 Instrumentation: Following instrumentation is required for process control: Purpose Instrumentation Monitor exhaust air temp. Temperature Indicator digital Monitor & control temp. of inlet air Temperature controller & indicator digital Monitor & control speed of pan’ RPM indicator & controller Monitor liquid solution flow rate Flow rate indicator Monitor humidity of inlet air Hygrometer Monitor atomizing pressure Pressure indicator Monitor inside pressure of coating pan With | ws nehelic gauge respect to room 2.8 Specific requirement: 1. Preferred make of PLC: Mitsubishi/Siemens 2. Preferred make of motor: Crompton/Kirloskar 3. AHU with HEPA filter arrangement for air supply, arrangement for HEPA filter integrity test should be considered,.AHU can be place on service floor. 4. Steam can be used for heating purpose 5. After stopping operation of coating pan there must be no diping of coating solution from spray gun 6. Pan Static pressure -20 Pa during closed operation 7. Inlet air temp.25°C to 100°C 8, Equipment should be with flame proof construction 9, Spraying angle & distance must be adjustable 10, view glass 11, Solution preparation tank with stirrer should be supplied with machine 12, Noise level below 80 db at a distance of I mt. from equipment 13. Vendor should mention Change over time from one product to another product & film/sugar coating Specifications Remarks 370 Technical requirement: 13. Usilities consumption A. Electricity: (Specify by supplies) B: Compress itt. (Specify by supplier) Sloan os sstenaarsaciaa (Specify by supplier) 14, Vendor should specify weight, size &capacity ,heat given(laside room & exhaust) of machine. 15, Arrangement of UPS (Optional) 16, Vendor shall provide special tools for maintenance of equipment 17. Industrial plug, cable, air tube is in scope of vendor 18, System security shall be provided to access the operation system(HMD 19. Arrangement for Batch record printing with necessary parameters (Optional) Documentation: List of all Documents (Not limited to this) tobe supplied along with equipment. Document shall be supplied in hard copy & soft copy. Sr. | Document to be supplied Qty | Remarks No. - 1 1 Design and operational quali 2 SAT/FAT proceduresOperatic Tsets_ j Maintenance manual, type of lubricants, lubrication 2 sets instruction, food grade certificate for lubricants [Calibration certificates ‘Warranty / Guarantee List of all components with referencing _ ing: [13 [Pre installation requirements a Installation requirements Installation manual "Calibration Report ofall sensors, conivollers, PLC, transmitters, indicators etc 19 Test certificates of all material of construction, approval 2 sets _ certificate of filter iL 20 | Test Certificates of software used in machine control/ "2 sets monitoring system. Constraints: Material of construction: All contact parts: SS 316 with mirror finish All non contaet parts: SS 304 with mat finish Gasket/seal/O ring: Food grade All welds should be ground finished Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Within 2 month of order finalization Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With deliver 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation. 6.2 Support Training program for operator & technical staf has to be included in offer. Glossary: -_ EL |: _] User Requirement Specification. {| _{ [Indian Institute of Integrative medicines / [| Design Qualification _[:_Hnstallation Qualification Operational Qualification | {| Performance Qualification Stainless Steel {| Material of Construction i: Horse Power16._| UPS H | Rotation Per Minute Current Goods Mant turing Practices Piping and instrumentation diagram Variable frequency drive | Programmable logic controller | Human Machine Interface Uninterrupted Power SupplINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(688)-11/Pur Dated:4.10.11 Sub: Pus Dear Sirs, 1ase ofTablet Inspection Machine We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envslop. ‘S.No. | Description of the material Qty 1 ‘Tablet Inspection Machine Or Detailed Specifications as per Annexure enclosed ‘You are requested to Tumnish your quotation with Iieratue” catalogue ete, superscribing quotation for Tablet Inspection Machine” duly mailed by courier'speed post so as to reach on or before 9.11.2011 upto2.30 PM to the address of the Director (Attn, Stores & Purchase Officer), Indian Institute of Integrative Medicine Canal Road, Jammu-180001.and the same will be opened on the same day at 3.30PM in the presence ‘of the authorized representatives ofthe bidders, iF any desire to attend Tender Open Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, fany allowed should be mentioned specifically ould be mentioned ia the offer. ‘Tax may also be taken into account while i is 135% iy: We are exempted for payment of Excise duty and necessary Duty Exemption Cerificate ean be issued aceord Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned inthe order. Payment: 20%% advance payment against Bank Guarantee of equivalent amount valid til time of supply ‘60% payment against supply of material at site (IM Jammu). 20% after installation and sucoessiul commissioning of equipment ‘Special Terms & Conditions Vender needs to submit thei client list and at least three successil installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith Al venders should fill URS of machineries piven along withthe tender document, without proper filling of URS, tenders will not be accepted, Validity of rates: A certificate of rates is also tobe attached by the supplier with the quotation that the rates quoted to ITM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Insttute or Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to he specified clerly. Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, ‘Note: - In ease the parties want to quote as Indian agents of foreign supplier, the following terms may be specie their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed clear terms in Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) TABLET INSPECTION MACHINE DOCUMENT NO. IIIM/URS/I1 EQUIPMENT ID PT-11 TABLE OF CONTENTS No. Particulars Page no. 32.__| INTRODUCTION LL | ABOUT THE PROJECT 3 12 | SCOPE. 3 13__| PURPOSE 3 1.4 | EQUIPMENT GENERAL DESCRIPTION, 3 15 IIDELINE FOR EQUIPMENT 3 33._| OPERATIONAL REQUIREMENT. 2.1 [CAPACITY q 2.2 _| PROCESS PARAMETER CONTROL q 2.3_| SAFETY FEATURI 7 2.4 _| POWER FAILURE & RECOVERY a 2.5_| CLEANING REQUIREMENT a 2.6_ | INPROCESS CONTROL 7 2.7_ | INSTRUMENTATION q 2.8 _| SPECIFIC REQUIREMENT 4 34,_| TECHNICAL REQUIREMENT 3 35,_| DOCUMENTATION 36 36._| CONSTRAINTS, MATERIAL OF CONSTRUCTION é MILE STONE & TIMELINES. 6 6,_| LIFE CYCLE G.1__| INSPECTION & TESTING 6 62 | SUPPORT z 7. GLOSSARY 7 Vendor Should specify their comments as“Yes” or “No” in remarks column. Specifications Remarks 1.0 INTRODUCTION: 1.36About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state of art cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical/ herbal drugs and For Information This user requirement specification will be recognized as an integral part of the procurement reference standards, drugs for clinical tials) manufactured under GMP conditions, For this purpose J D Pharma Consultants is engaged as a project consultant 1.37Seope: For Information‘agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the IIIM. 1.38 Purpose: ‘This document was generated under the authority of the IIM for the purpose of specifying the user requirement fora Tablet Inspection machine. The system shall be used for inspection of tablet for any defect For Information 1.39Equipment General Description: The tablet inspection machine will be operated independently of other equipment and systems ‘and will be located in a designated operating area. The machine is used for inspection of tablet after compression for any defects. Process involves following steps 1. Charging of material in hopper. 2. After charging of tablet when tablet come over rotating belt tablet shall rolled and inspected manually 3. Defected tablet is sorted ouit and good tablet shall move forward, For Information 1.40Guidelines for equipment: ‘The equipment should comply with following guidelines/standar: Schedule M,WHO GMP For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 2,50,000 tablet par hour 2.2 Process control features: Following parameters shall be controlled by machine: 8, Belt speed 9, Vibration contrat 2.3 Safety Features: Following safety features required: 1, Emergency stop function 2. Closure of al rotating part 1. Wherever possible, warning symbols should be provided Appropriate failure detection s 2.4 Power failure & recovery: In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, or other major utility and will require operator intervention to re-start After regain of power the equipment should start from the step it stopped 2.5 Cleaning requirement All contact parts should be easily dismantled and cleanable, cleaning shall be done manual 2.6 In process control: Not applicable 2.7 Instrumentation: Following instrumentation is required for process control: Purpose Instrumentation Belt speed VED Vibration of hopper Vibration controller 2.8 Specific requirement: 1. Preferred make of motor: Crompton! Kirloskar2. Appropriate lighting arrangement shall be provided for inspection of tablet 2. Noise level below 80 db at a distance of I mt. from equipment. 4. Vendor should mention Change over time from one product to another product 3.0 Technical requirement: 20, Uiilites consumption A: Electricity... sents saSpecify by supplier) 21, Vendor should specify weight, size &capacity heat given(laside room) of machine. 22, Vendor shall provide special tools for maintenance of equipment 23, Industral plug, cable, air tube is in seope of vendor Documentation: List of all Documents (Not limited to this) to be supplied along with equipment. Document 1 Design and operational qualification Z [ SAT/FAT procedures 3 Operation manual - 4 ‘Maintenance manual, type of lubricants, lubrication _ instruction, food grade certificate for lubricants 3 Spare parts manual _ Deets 6 | Allengineering drawings, sbuilt drawings | 2 sels 7 8 2 i gompon flow diagrams - 12 Civil foundation drawings (If applicable) 2 sets 13 Pre installation requirements 14 ris] : — 16 Technical literature, data sheets and equipment catalogues _ - 17 DQ. 1Q. OO documenis 18 Calibration Report of all sensors, controllers, ! transmitters, indicators ete. ee i ! 9 est certificates of all material of construction 4.0 Constraints: 5.1 Material of construction: 1, Alllcontact parts: SS 316 with mirror finish 2, All non contact parts: SS 304 with mat finish 3. Gasket/seal/O ring: Food grade 4, All welds should be ground finished ime lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Two month of order finalization 7. Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization, 8, Submission of FAT/SAT specifications: three weeks before FAT 9. 1Q & OQ protocol: With deliver 52 600 Life Cyele 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation. 6.2 Support: ‘Training program for operator & technical staff has to be ineluded in offer Glossary: [2] User Requirement Specification. | Indian Institute of Integrative medicines | tl Design Qualification ([_‘Tnstallation Qualification {Operational Qualification Performance Qualification Stainless Steel | { Material of Construction | Horse Power | Rotation Per Minute GMP ' Current Goods Manufacturing Practices [Pa Db Piping and instrumentation diagram | NED. Variable frequency drive RPM PLC - T_| Programmable logic controller HMI |_| Human Machine Interface [ups - Uninterrupted Power Suppl; lINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(689)-11/Pur Dated:4.10.11 Sul Pu tase ofStrip Packing Machine Dear Sirs, We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. S.No. | Description of the material ‘Qty 7 ‘Strip Packing Machine om Detailed Specifications as per Annexure enclosed ‘You are requested to Turnish your quotation with Ineratue’vatalogue ete. supersribing quotation for Strip Packing Machine™ duly mailed by courier/speed post so as to reach on or before 9.11.2011 upto2.30 PM to the address ofthe Director (Attn Stores & Purchase Officer), Indian Institute of Integrative Medicine Canal Road, Jammu-180001-and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives ofthe bidders, if any desire to atend Tender Opening. Prices should he quoted on FOR HIM Jammu Discount: Institutional Discount, if any allowed should be mentioned specifically Taxes and Levies: Should be mentioned inthe offer. JAK Entry Tax: Entry Tax may also be taken into account while quoting, Presently Entry Tax is 13.5% Excise Duty: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate ean be issued accordingly. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid til time of supply ‘6% payment against supply of material at site (IM Janinw). 20% after installation and successful commissioning of equipment ‘Soscial Terms & Conditions \Vender needs to submit their client list and at least three successil installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith, All venders should fill URS of machineries given along with the tender document, without proper filling of URS, tenders will not be accepted ‘Validity of rates: A certificate of rate i also tobe attached! by the supplier with the quotation that the rates quoted to ITM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Insttate or Govt. Organization, ‘Warranty/Guarantee: Quotation should specifically mention the warranry clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of acceptance / rejection of tender is reserved with Director, ILIM, Jamm, Note: - In case the parties want to quote as Indian agents of foreign suppliers, te following terms may be specified in clear terms In their offers, 1. FOB/CIF Price. 2. Country of origin, 3 Shipping details, 4. Agency commission if any. ‘Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) STRIP PACKING MACHINE DOCUMENT NO. IIM/URS/I2 EQUIPMENT ID NO. PT-12 TABLE OF CONTENTS SNo. Particulars Page no. 37._ | INTRODUCTION L.1_| ABOUT THE PROJECT 3 12 | SCOPE 3 13 | PURPOSE 3 14 | EQUIPMENT GENERAL DESCRIPTION 3 TS__| GUIDELINE FOR EQUIPMENT 3 38._| OPERATIONAL REQUIREMENT 2.1_| CAPACITY 4 2.2 _| PROCESS PARAMETER CONTROL, 4 2.3 _| SAFETY FEATURES, 4 2.4 _| POWER FAILURE & RECOVERY 4 2.5__| CLEANING REQUIREMENT 4 2.6 _| INPROCESS CONTROL 3 2.7_| INSTRUMENTATION s 2.8 _| SPECIFIC REQUIREMENT 3 39, | TECHNICAL REQUIREMENT 6 40,__| DOCUMENTATION oT 41._| CONSTRAINTS MATERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 6._| LIFE CYCLE 6.1__| INSPECTION & TESTING 7 62 | SUPPORT 7 Te 8 ‘Vendor Should specify their comments as*Yes” or “No” in remarks column, Specifications Remarks 1.0 INTRODUCTION: 1.41About The Project Indian Insite of Integrative Medicine (11M) i national Inttte ofthe Council of Scientific industrial Research (CSIR) of India, with primary focus of research on dng discovery from. | For Information natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state ‘of art cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get theie products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant1.42Scope: ‘This user requirement specification will be recognized as an integral par ofthe procurement ‘agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this dacument as well asthe standard purchasing term and conditions ofthe HIM, For Information 1.43 Purpose: ‘This document was generated under the authority of the IIM for the purpose of specifying the user requitement fora strip packing machine. Te system shall be used to perform packing of tablet & capsules. For Information 1.4Equipment General Description: The strip packing system will be operated independently of other equipment and systems and will be located in a designated operating area, Stip packing machine shall use for packing of tublet & capsules For Information 1.45Guidelines for equipment: ‘The equipment should comply with following guidelines‘tandard Schedule M,WHO GMP For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capa 100 strip /min, 2.2 Process control features: Following parameters shall be controlled by machine: 10. Machine speed LL. Sealing temperature 12. Collation of strips 13. Rejection of strip with empty & broken tablet Notification to operator for operational control: 38, Alarm notification there is improper supply of compressed air 2.3 Safety Features: Following safety features required 1, Emergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, or other major utility and will require operator intervention to re-start.After regain of power the equipment should start from the step it stopped. 25 Cleaning requirement: All contact parts should be easily dismantled and cleanable, cleaning shall be done manually 2.6 In process control: Manual sampling for inprocess sampling shall be considered 2.7 Instrumentation: Following instrumentation is required for process control: Purpose Instrumentation Monitor & control temperature of sealing | Temperature indicator with controller station “Monitor air pressure Pressure gauge Monitor number of strips Counter,Sense presence of sealing foil Sensor Adjustment cutting of printed matter on strip] Eye mark sensor 2.8 Specific requirement: 1. Preferred make of motor: Crompton/ Kirloskar 2. Preferred make of PLC: Siemens/Mitsubishi 3. Online batch coding system (Inkjet) 4, Online camera for detection of defect in batch coding, broken tablet, empty pocket 5. Non fill detection & rejection 6. Noise level below 80 db at a distance of 1 mt. from equipment. 7. Vendor should mention Change over time from one product to another product Technical requirement: ‘consumption: A: Blectricitytssorsvsssseseeesnseesneeed Specify by supplier) B: Compressed air: (Specify by supplier) C: Dust Extraction: «(Specify by supplier) D: Chilled water: (Specify by supplier) 2. Vendor should specify weight, size &capacity ,heat given(Inside room) of machine, 26, Vendor shall provide special tools for maintenance of equipment 27. Industrial plug, cable, air tube is in scope of vendor 28. Arrangement of UPS (Optional) 29, Batch record printing with all necessary parameters (Optional) 30. System security shall be provided to access operating system(HMI) Documentation: List of all Documents (Not limited to this) to be supplied along with equipment. Document shall be supplied in hard copy & soft copy. Sr. | Document to be supplied Qy | Remarks 1 Design and operational qualification 2 sets 2 SAT/FAT procedures - __ | 2sets | 3 | Operatic [2 sets 4 ‘Maintenance manual, type of lubricants, lubrication 2 sets instruction, food grade certificate for lubricants Spare parts manual 12 sets ‘All engineering drawings, P&ID, As built drawings sets [ List of instruments - ~ | 2sets Calibration certificates 2 sets arranty / Guarantee of all components awings (If applicable) | Pre installation requirements Installation requirements Technical literature, data sheets and equipment atalogue DQ, 1Q. OG and PQ documents ‘18 Calibration Report of all sensors, controllers, transmitters, indicators ete. 19 | Test certificates of all material of construction Constraints: 5.1 Material of construction:All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade All welds should be ground finished Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Within two month of order finalization Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT IQ & OQ protocol: With de 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation, 6.2 Support Training program for operator & technical staff has to be included in offer. ~ [J User Requirement Specification. _ [5 | Indian Institute of Integrative medicines Design Qualification Installation Qualification | Operational Qualification Ty Performance Qualification Stainless Steel Material of Construction Horse Power | Rotation Per Minute i “7 | Current Goods Manufacturing Practices |_| Piping and instrumentation diagram i Variable frequency drive | Programmable logic controller Human Machine Interface Uninterrupted Power SupplINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(690)-11/Pur Dated:4.10.11 Suh.: Purchase ofBlister Packing Machine Dear Sirs, We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envslop. S.No. | Description of the material Qty 1 Blister Packing Machine Or Detailed Specifications as per Annexure enclosed ‘You are requested to Tumnish your quotation with Iieratur’ catalogue ee, Superscribing quotation for Blister Packing Machine”duly mailed by courier speed post so as to reach on or before 911.2011 upto2.30 PM to the address ofthe Director (Attn Stores & Purchase Officer), Indian Institute of Integrative Medicine Canal Road, Janvmu-1S0001.and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, if any desire to atend Tender Opening. Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, fany allowed should be mentioned specifically ould be mentioned ia the offer. ‘Tax may also be taken into account while i is 135% iy: We are exempted for payment of Excise duty and necessary Duty Exemption Cerificate ean be issued aceord Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned inthe order. Payment: 20%% advance payment against Bank Guarantee of equivalent amount valid til time of supply ‘60% payment against supply of material at site (IM Jammu). 20% after installation and sucoessiul commissioning of equipment ‘Special Terms & Conditions Vender needs to submit thei client list and at least three successil installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith Al venders should fill URS of machineries piven along withthe tender document, without proper filling of URS, tenders will not be accepted, Validity of rates: A certificate of rates is also tobe attached by the supplier with the quotation that the rates quoted to ITM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Insttute or Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to he specified clerly. Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, ‘Note: - In ease the parties want to quote as Indian agents of foreign supplier, the following terms may be specie their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed clear terms in Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) BLISTER PACKING MACHINE DOCUMENT NO. HIM/URS/I3 EQUIPMENT ID NO. 13 TABLE OF CONTENTS S.No. Particulars Page no. 42, [INTRODUCTION 1.1_| ABOUT THE PROJECT 3 12 | SCOPE 3 13 | PURPOSE 3 14__ | EQUIPMENT GENERAL DESCRIPTION 3 1.5 | GUIDELINE FOR EQUIPMENT 3 43._| OPERATIONAL REQUIREMENT 2.1_| CAPACITY q 2.2 _| PROCESS PARAMETER CONTROL 4 2.3 _| SAFETY FEATURES 4 2.4 | POWER FAILURE & RECOVERY 4 2.5_| CLEANING REQUIREMENT 4 2.6 _ | INPROCESS CONTROL 3 2.7_ | INSTRUMENTATION 5 2.8 _[ SPECIFIC REQUIREMENT 5 [TECHNICAL REQUIREMI 6 45. | DOCUMENTATION 67 46.__| CONSTRAINTS ERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 6. | LIFE CYCLE 6.1 ___| INSPECTION & TESTING 7 6.2 | SUPPORT 7 Ts ‘GLOSSARY a Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 1.46About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state of art cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this, purpose J D Pharma Consultants is engaged as a project consultant. For Information 1.47Scope: This user requirement specification will be recognized as an integral part ofthe procurement ‘agreement with the selected equipment vendor, The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the HIM. For Information1.48 Purpose: ‘This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for a blister packing machine, The system shall be used to perform packing of tablet & capsules, For Information 1.49 Equipment General Description: ‘The blister packing system will be operated independently of other equipment and systems and will be located in a designated operating area. Blister packing machine shall use for packing of tablet & capsules. A typical process involves the following steps: In blister pack operation, PVC base film web is drawn off from a reel and fed into the blister forming unit where blisters are continuously formed. The web is then led to the sealing unit over a guide track Over the guide track, the product is filled into the blisters by suitable automatic filling unit before the web enters the sealing unit, Aluminum foi is drawn off from a separate reel and is fed to the sealing unit where itis sealed with the base web, thus enclosing the product hermetically .The filled and sealed web is then fed by an indexing mechanism into the pack punch unit where the packs are separated from the web. The web trim is sheared off to allow collection. The blister pack may either be collected in bins or may be conveyed over a belt for further handiing. For Information 1.50Guidelines for equipment: ‘The equipment should comply with following guidelines‘standard: Schedule M,WHO GMP For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 100 blister/min. 2.2 Process control features: Following parameters shall be controlled by machine: 14. Machine speed 15. Blister Sealing & forming temperature 16. Collation of blisters 17, Rejection of blister with empty & broken tablet Notification to operator for operational control: 39, Alarm notification if there is improper supply of compressed air 2.3 Safety Features: Following safety features require: 1, Emergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery: In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, or other major utility and will require operator intervention to re-start.After regain of power the equipment should start from the step it stopped. 2.5 Cleaning requirement: All contact parts should be easily dismantled and cleanable, cleaning shall be done manuall 2.6 In process control Manual sampling for inprocess sampling shall be considered 2.7 Instrumentation: Following instrumentation is required for process control: Purpose Instrumentation Monitor & control temperature of sealing | Temperature indicator with controller‘& forming station Monitor air pressure Pressure gauge Monitor number of blister Counter Sense presence of forming/sealing foil Sensor 2.8 Specific requirement: 1. Preferred make of motor: Crompton’ Kirloskar 2. Preferred make of PLC: Siemens/Mitsubishi 3. Online batch coding system (Inkjet) 4. Online camera for detection of defect in batch coding, broken tablet, empty blister. 5. Noise level below 80 db at a distance of 1 mt, from equipment. 6. Vendor should mention Change over time from one product to another product 10.2 Technical requirement: 31, Utilities consumption: A: Blectticityt..... scsseesensee( Specify by supplier) B: Compressed it .......,eeesssee(Specify by supplier) C: Dust Extraction: . {Specify by supplier) D: Chilled water: «Specify by supplier) 32. Vendor should specify weight, size &capacity heat given(Inside room) of machine, 33. Vendor shall provide special tools for maintenance of equipment 34, Industrial plug, cable, air tube is in scope of vendor 35. Arrangement of UPS (Optional) 36. Batch record printing with all necessary parameters (Optional) 37. System security shall be provided to access operating system(HMI) Documentation List of all Documents (Not limited to this) to be supplied along with equipment. Document shall be supplied in hard copy & soft copy. Sr, Document to be supplied Qty | Remarks No. I Calibration certificates 9, Warranty / Guarantee __ cts 10 List of ali components with referencing [Ysets | process flow diagrams 2 Civil foundation drawings (if applicable) | Pre install _ . Ha Tnstailation requirements - 15 Tastallation manual_ 16 ‘Technical literature, data sheets and equipment — eu 17 DQ. IQ O@and PQ document 18 Calibration Report of all sensors, controllers, i transmitters, indicators ete. 19 Test certificates of all material of construction Constraints: 5.1 Material of construction:All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade All welds should be ground finished Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Within two month of order finalization Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT IQ & OQ protocol: With deliver 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation, 6.2 Support Training program for operator & technical staff has to be included in offer. Glossary: L URS. _[: | User Requirement Specification. Indian Institute of Integrative medicines Design Qualification ‘Tnstallation Qualification | Operational Qualification i { Performance Qualification Stainless Steel | | Material of Construction Horse Power | Rotation Per Minute { Current Goods Manufacturing Practices Piping and instrumentation diagram | | Variable frequency drive {:_| Variable frequency drive - - [| Programmable logic controller [| Human Machine Interface Ls errupted Power SupplyINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2569023, 2569019, No. 2(691)-11/Pur Dated:4.10.11 Dear Sirs, We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. S.No. | Description of the material ‘Qty 7 Turn Table om Detailed Specifications as per Annexure enclosed ‘You are requested to Turnish your quotation with Iterature”eatalogue ete, superseribing quotation for Tum Table"duly mailed by courierspeed post so as 1 reach on or before 09.11.2011 upto?.30 PM. to the address ofthe Director (Attn. Stores & Purchase Officer), Indian Institute of Integrative Medicine Canal Road, Jammu-180001 and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, iF any deste to attend Tender Opening. Prices should he quoted on FOR 111M Jammu Discount: Institutional Discount, if any allowed should be mentioned specifically Taxes and Levies: Should be mentioned inthe offer. JAK Entry Tax: Entry Tax may also be taken into account while quoting, Presently Entry Tax is 13.5% Excise Duty: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate ean be issued accordingly. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid til time of supply ‘6% payment against supply of material at site (IM Janinw). 20% after installation and successful commissioning of equipment ‘Soscial Terms & Conditions ‘ender needs to submit their client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith, All venders should fill URS of machineries given along with the ender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rates i also tobe attached! by the supplier with the quotation tha dhe rates quoted to TEM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Insttate or Govt. Organization, ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only ater murual consent / acceptance of HIM & Suppliet. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of faceeptance / rejection of tender is reserved with Director, ITIM, Jamm, Note: - In case the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers, 1. FOB/CIF Price. 2. Country of origin, 3 Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerER REQUIREMENT SPECIFICATIONS ( ) TURN TABLE DOCUMENT NO. IM/URS/20 EQUIPMENT ID NO. PL-20 TABLE OF CONTENTS SNe. Particulars Page no, 47._| INTRODUCTION 1.1 | ABOUT THE PROJECT 3 12 [SCOPE 3 13 | PURPOSE 3 14 EQUIPMENT GENERAL DESCRIPTION. 3 15] GUIDELINE FOR EQUIPMENT 3 48. OPERATIONAL REQUIREMENT 2.1 _| CAPACITY z 2.2 _| PROCESS PARAMETER CONTROL 4 2.3 _| SAFETY FEATURES 4 3.4 | POWER FAILURE & RECOVERY a 2.5 CLEANING REQUIREMENT 4 2.6 _ | INPROCESS CONTROL 4 2.7_ | INSTRUMENTATION 5 3.6 _| SPECIFIC REQUIREMENT 3 9, TECHNICAL REQUIREMENT 3 50. DOCUMENTATION 67 3i,_| CONSTRAINTS MATERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 6._| LIFE CYCLE 6.1 __| INSPECTION & TESTING a 62 | SUPPORT 3 Ts i=} Specifications Remarks 1.0 INTRODUCTION: 1.51About The Proje Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D siudies & for smal] and medium manufactures to get their products (botanical! herbal drugs and reference standards, drugs for clinical trials) manufactured undet GMP conditions. For this, purpose J D Pharma Consultants is engaged as a project consultant, For Information 1.52Seope: This user requirement specification will be recognized as an integral part ofthe procurement ‘agreement with the selected equipment vendor. The equipment supplier or vendor will abide by For InformationThe information and conditions set forth by this document as well as the standard purchasing term and conditions of the IIIM. 1.53 Purpose: ‘This document was generated under the authority of the IIM for the purpose of specifying the user requirement for Turn Table, The system will be used for movement of bottles from one machine to another machine For Information 1.54Equipment General Description: Liquid turn table machine will be operated independently of other equipment and systems and will be located in a designated operating aca For Information 1.55Guidelines for equipment: ‘The equipment should comply with following guidelines/standard: Schedule M,WHO & FDA Guidelines For Information Specifications Remarks 2.0 Operational Requirement 21 Capacity/Output: 307 2.2. Process control features Following parameters shall be controlled by machine: 18, Speed of motor 2.3 Safety Features: Following safety features require: 1, Emergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery: Machine settings should not get disturbed due to power failure, Machine should not restart without human intervention 2.5 Cleaning requirement: All contact parts should be easily dismantled and cleanable 2.6 In process control: Not applicable 2.7 Instrumentation: Following instrumentation is required for process control: ‘Type of control Instrumentation Monitor & control RPM of disk Different step pull Specifications Remarks 2.8 Specific requirement: 1. Preferred make of motor: Crompton/kirloskar 2. Direction of machine: clock wise 3. Machine on off power switch 103 Technical requirement: 38. itlities consumption: A: Elect... soseneco( Specified by supplier) 39, Vendor should specify weight, size & heat given of machine. 40, Vendor shall provide special tools for maintenance of equipment41. Industrial plug, cable, isin scope of vendor Documentation: ' List of all Documents (Not limited to this) to be supplied along with equipment. Document | shall be supplied in hard copy & electronic edible version in English language. Sr. | Document to be supplied Qy Remarks No. T ‘Design and operational qualification 2 SAT/FAT procedures 3 | Op 4 | Maintenance manual, type of lubricants, lubrication instruction a 3 Spare parts manual - 6 All engineering drawings, P&ID, As built drawings | 7__| List of instruments 8 Calibration certificates 9 varranty - List of ali components with referencing Prov i - 2 sets 12___| Pre installation requirement ~ [2 sets 13. Installation requirements — | 2 sets 14 ystallation ma 2 set: 15 ‘Technical literature, data sheets and equipment 2sets catalogues - et 16 DQ, 1Q. OQ and PQ documents | Dsets 17 “Test certificates of all material of construction sets Constraints: 5.1 Material of construction: Material of construction; SS 304 Gasket/seal/O ring/pipe: Food grade Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Within two month of order finalization Submission of detail design specification & electrical & mechanical drawing: weeks of order finalization, Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) Afier delivery & successful installation, 6.2 Support: Training program for operator & technical sta has to-be included in offer. Glossary: - 1. URS — | User Requirement Specification. 2. TIM ‘1 | Indian Institute of Integrative — _|__i medicines 3. [DQ |_| Design Qualification | 4.19 - - | [Installation Qualification 5. 0Q | - | Operational Qualification 6. PQ _|1_| Performance Qualification 7. SS [:_| Stainless SteelMaterial of Construction Horse Power Rotation Per Minute ‘| Current Goods Manufacturing i Variable frequency drive ___|1_ | Programmable logic controller :_| Human Machine Interface _[: [uninterrupted Power Supply |INDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones 0191-2569000, 256900, to 10 (11 Lines) Telefax: 2569028, 2569019, No. 2(692)-11/Pur Dated:4.10.11 Sub.: Purchase ofSyrup Manufacturing Plant Dear Sirs, We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envslop. S.No. | Description of the material Qty T ‘up Manufacturing Plant Or 2 Manufacturing Plant Oo 3 Liquid Storage Tank oO Detailed Specifications as per Annexure enclosed ‘Yo are requested vo furs your quotation with Teratre”cfalogue ee. superseribing quotation for Syrup Manufacturing Plant, Liquid Manufacturing Plant & Liguid Storage Tank” duly mailed by curersped pos soso reach on or before 14.11.2011 upto230 PM tothe adress ofthe Director (At, Stores & Purchase Office), Indian Insite of Integrative Meine Canal Ros Jamim-INODD] and the same ville opened onthe same day a ..0PM inthe presence of the ahorized representatives ofthe bidder, if any desire to attend Tender Opening Discount Insitional Discount, irany allowed should be mentioned specifically “Taxes and Levies: Should be mentioned in the oer. JK Entry Tax: Entry Tax may als be taken inte account while quoting, Presents Entry Tan fs 1.8% Excise Duty: We are exempted for payment of Face dy and necessary Daty Fxerption Certifies can be ested acon Delivery: Within the leadsime ste essence ofthe order ais tobe specifiy mentioned in the ode. Payment: 20% advance payne agsinst Bank Guarantee of equivalent amount valid til ime of supply 6a payment aginst supply of materi at site ITIN Jamar) afer instalation and succesfl commissioning of equipment ‘Soccial Terms & Conditions: ‘ender needs to submit thei client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR THM Jamma including packing and forwarding charges & prescribed in specified format attached herewith All venders should fill URS of machineries given along withthe tender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rate is also tobe attached by the supplier with the quotation that the rates quoted to TIM, Jammu is not higher than the rates quoted to any other CSIR LaboratoryInsttute or Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of aceeptance / rejection of tender is reserved with Director, IIIM, Jammu, ‘Note: - In ease the parties want to quote as Indian agents of foreign suppliers, the following terms their offers, 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed ay be specified in clear terms in Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) SYRUP MANUFACTURING PLANT DOCUMENT NO. HIM/URS/I5 EQUIPMENT ID-LI-15 TABLE OF CONTENTS S.No. Particulars Page no. 52._ | INTRODUCTION 1.1_| ABOUT THE PROJECT 3 12 | SCOPE 3 13 | PURPOSE 3 14__ | EQUIPMENT GENERAL DESCRIPTION 3 1.5 | GUIDELINE FOR EQUIPMENT 3 ‘OPERATIONAL REQUIREMENT. CAPACITY, q PROCESS PARAMETER CONTROL 4 ‘SAFETY FEATURES 4 POWER FAILURE & RECOVERY 4 CLEANING REQUIREMENT 4 INPROCESS CONTROL 4 INSTRUMENTATION, 5 ‘SPECIFIC REQUIREMENT 56 34._ | TECHNICAL REQUIREM 7 DOCUMENTATION 7 56. | CONSTRAINTS. ERIAL OF CONSTRUCTION 5 MILE STONE & TIMELINES 8 6. | LIFE CYCLE 6.1 __ | INSPECTION & TESTING 8 6.2 | SUPPORT 9 Ts ‘GLOSSARY 9 Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 1.56About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state of art cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions, For this, purpose J D Pharma Consultants is engaged as a project consultant. For Information 1.57Scope: This user requirement specification will be recognized as an integral part ofthe procurement agreement withthe sek the information and conditions set forth by this document as well as the standard purchasing term and conditions of the ITM sd equipment vendor, The equipment supplier or vendor will abide by For Information1.58 Purpose: This document was generated under the authority of the IIIM for the purpos of specifying the user requirement for syrup manufacturing plant, The system shall be used for sugar syrup reparation, For Information 1.59Equipment General Description: ‘The syrup manufacturing plant will be operated independently of other equipment and systems. and will be located in a designated operating area. Syrup manufacturing vessel should be vertical -cylindrical with jacket with suitable non asbestos’s and chlorine free material as insulation Machine should have bottom ent propeller stirrer. For Information 1.60Guidelines for equipment: ‘The equipment should comply with following guidelines/standard: Schedule M,WHO For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 500 It. 22 Process control features: Digital controller / display of: ‘Temperature of product on panel. Weight (Load cell) display on vessel. Auto process parameter such as valve open ( solenoid valve operated), time recording Speed of stirrer Flow control for purified water. CIP control parameters. 2.3 Safety Features: Following safety features required: 1, Emergency stop funetion 2. Closure of all rotating part 3,_Wherever possible, warning symbols should be provided 24 Power failure & recovery: Machine settings should not get disturbed due to power failure. Machine should not restart \ithout human intervention, 25 Cleaning requirement: All contact parts should be easily dismantled and cleanable, for contact part CIP shall be considered. 2.6 In process control: sampling port for inprocess sampling of liquid is required. 2.7 Instrumentation: Following instrumentation is required for rocess control: ‘Type of control Instrumentation Monitora control process time Timer digital Weight of material Digital weight display Speed of stirrer VED Monitor of temperature ‘Temperature controller digital ‘Monitor pressure Pressure gauge Specific requirement: Preferred make of PLC: Mitsubshi /Siemens Preferred make of motor: Crompton/Kirloskar Syrup manufacturing vessel should be vertical ,cylindrical with jacket with suitable non asbestos’s and chlorine free material as insulation (Limpet coil.)Jacket shall have inlet for steam , cooling water and outlet for condensate , cooling water. Syrup manufacturing vessel should have propeller stirrer bottom entry with mechanical double seal. Mechanical seal should have cooling facility with interlocking for cooling water. The syrup manufacturing should have operation panel ,control panel Interconnected product piping should be of SS 316 L with filter for tanks All bottom valve should be flushed type. Product piping should be orbital welding and electro polished. All vessels should have man hole, light arrangement. All vessels should be jacketed with $5304 with pressure holding capacity of 4 kg/cm2 and hydraulically tested at 6ke/cm2 insulation should be asbestos free. safety valve should be installed Sugar syrup filtration device should be provided as par machine capacity design Tank should be of $$316 L with 240 grit finish internally and externally $5304 with mat finish. Load cell should be provided to all vessel to facilitate the batch making The tank should have CIP system. Height of flush bottom valve from ground should be 600mm. Vacuum transfer system for sugar/ sorbitol Vacuum pump is in scope of vendor Nozzle on vessel: A: D.M. water inlet with cleaning ball . B: Sugar inlet vacuum transfer. C: Two 25 mm spare nozzle D: Temperature sensor. Specifications Remarks Technical requirement: {Specify by supplier) (Specify by supplier) C: Compressed air: (Specify by supplier) 43. Vendor should specify weight, size & heat given of machine 44, Vendor shall provide special tools for maintenance of equipment 45. Industrial plug, cable, air tube is in scope of vendor 46, ‘System security shall be provided to access the operation system(HMI) 47. Arrangement for Batch record printing with necessary parameters (Optional) Documentation: List of all Documenis (Not limited to this) tobe supplied along with equipment, Document shall be supplied in hard copy & electronic editable version in English language. Document to be supplied Remarks pare Pi : All engineering drawit of instruments _ ration certificates 11 P& I process flow diagrams 2 sets13 __| Pre installation requirements —— T2sets 14 Thstalfation requirements a (Deets 15 Installation manual_ - | 2sets 16 ‘Technical literature, data sheets and equipment 2 sets catalogues 17 | DQ.1Q, OQ documents, - [2sets 18 Calibration Report of all sensors, controllers, PLC, 2 sets: transmitters, indicators ete. i [19 “Test certificates of all material of construction sets 4.0 Constraints: Material of construction: 5. All contact parts: SS 316 with mirror 6. All non contact parts: SS 304 with ma 7. Gasket/seal/O ring: Food grade $2 Timelines: 10. Response to URS & submission of quotation: Within 2 weeks IL. Delivery of machine: within 2 month of finalization of order 12, Submission of detail design specification & electrical & mechanical drawing: within 3 weeks of order finalization. 13. Submission of FAT/SAT specifications: three weeks before FAT 14, 1Q & OQ protocol: With delivery finish finish 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) After delivery & successful installation. 6.2 Support Training program for operator & technical staff has to be included in offer. = {User Requirement Specification. | Indian Institute of Integrative medicines Design Qualification | Installation Qualification erational Qualification, | Performance Qualification Stainless Steel : Material of Construction [Horse Power Rotation Per Minute T Current Goods Manufacturing Practices Piping and instrumentation diagram Variable frequency drive | Programmable logic controller Human Machine Interface {Uninterrupted Power SupplyUSER REQUIREMENT SPECIFICATIONS (URS) LIQUID MANUFACTURING PLANT DOCUMENT NO. HIM/URS/I6 EQUIPMENT ID LI-16 TABLE OF CONTENTS SNe. Particulars Page no. 57._| INTRODUCTION I. | ABOUT THE PROJECT 3 12 | SCOPE 3 13__| PURPOSE 3 14 | EQUIPMENT GENERAL DESCRIPTION 3 15 | GUIDELINE FOR EQUIPMENT 3 38._| OPERATIONAL REQUIREMENT 2.1_| CAPACITY a 2.2 _| PROCESS PARAMETER CONTROL 4 2.3 _| SAFETY FEATURES 4 2.4 | POWER FAILURE & RECOVERY 4 2.5 _| CLEANING REQUIREMENT 4 2.6 _| INPROCESS CONTROL 4 2.7_| INSTRUMENTATION 3 3.6_| SPECIFIC REQUIREMENT 36 39._| TECHNICAL REQUIREM 7 60, | DOCUMENTATION 7 6. S S ERIAL OF CONSTRUCTION = MILE STONE & TIMELINES 3 6._ [LIFE CYCLE 6.1_ | INSPECTION & TESTING 3 62 | SUPPORT 9 a: GLOSSARY 3-10 Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 1.61About The Project: Indian Institute of Integrative Medicine (IIIM) is « national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug diseovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for smal] und medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this, purpose J D Pharma Consultants is engaged as a project consultant. Information 1.62Scope: ‘This user requirement specification will be recognized as an integral part of the procurement For Information‘agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the IIIM. 1.63 Purpose: ‘This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for Liquid manufacturing plant. The system shall be used for Liquid syrup product preparation, For Information 1.64Equipment General Description: The Liquid manufacturing plant will be operated independently of other equipment and systems ‘and will be located in a designated operating area. Liquid manufacturing vessel should be vertical ,eylindrical with jacket with suitable non asbestos’s and chlorine free material as insulation. Machine should have bottom entry propeller stirrer. For Information 1.65Guidelines for equipment: ‘The equipment should comply with following guidelines‘standard: Schedule M,WHO &USFDA Guidelines For Information Specifications Remarks 2.0 Operational Requirement 500 ltr. 2.1 Capacit 22 Process control features: Digital controller / display of: ‘Temperature of product on panel. Weight (Load cell) display on vessel. Auto process parameter such as valve open ( solenoid valve operated), Temperature time recording Speed of stirrer Flow control for purified water. CIP control parameters, 2.3 Safety Features: Following safety features required 1. Emergency stop funtion 2. Closure of all rotating part 3. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery: Machine settings should not get disturbed due to power failure, Machine should not restart without human intervention 2.5 Cleaning requirement All contact parts should be e be considered sily dismantled and cleanable, for contaet part CI 2.6 In process control: Sampling port for inprocess sampling of liquid is required. 2.7 Instrumentation: Following instrumentation is required for process control: Type of control Instrumentation ‘Monitor& control process time Timer digital Weight of material Digital weight display Speed of stirrer VED Monitor of ‘Temperature controller digital Monitor pr Pressure gauge Specific requirement Preferred make of PLC: Mitsubshi /SiemensPreferred make of motor: Crompton/Kirloskar Syrup manufacturing vessel should be vertical ,cylindrical with jacket with suitable non asbestos’s and chlorine free material as insulation (Limpet coil.) Jacket shall have inlet for steam , cooling water and outlet for condensate , cooling water. Syrup manufacturing vessel should have propeller stirrer bottom entry with mechanical double seal. Mechanical seal should have cooling facility with interlocking for cooling water. Inline homogenizer with recirculation arrangement required The syrup manufacturing should have operation panel, control panel Interconnected product piping should be of SS 316 L with filter for tanks All bottom valve should be flushed type. Product piping should be orbital welding and electro polished. All vessels should have man hole, light arrangement. All vessels should be jacketed with $5304 with pressure holding capacity of 4 kg/cm2 and hydraulically tested at 6ke/cm2 insulation should be asbestos free. safety valve should be installed. Liquid filtration device should be provided with zero hold up horizontal plate type. Tank should be of SS316 L with 240 grit finish internally and externally SS304 with mat finish, Load cell should be provided to all vessel to facilitate the batch making The tank should have CIP system. Height of flush bottom valve from ground should be 600mm, Nozzle on vessel: A: D.M. water inlet with cleaning ball . B; Sugar syrup inlet C: Two 25 mm spare nozzle . D: Temperature sensor. Specifications Remarks 10.5 Technical requirement: 48. Usiities consumption: A. Electricity (Specify by supplier) B: Steam; «Specify by supplier) 49. Vendor should specify weight, size & heat given of machine. 50. Vendor shall provide special tools for maintenance of equipment 51. Industrial plug, cable, air tube isin scope of vendor 52, System security shall be provided to access the operation system(HMD 53. Arrangement for Batch record printing with necessary parameters (Optional) Documentation: List of all Documents (Not limited to this) tobe supplied along with equipment. Document shall be supplied in hard copy & electronic editable version in English language. ‘Document to be supplied Qty | Remarks il Design and oper SAT/FAT procedures Operation manual — Maintenance manual, type of lubricants, lubrication instruction - Spare parts manual_ All engineering drawin; List of instruments _ [Calibration certificates s, P&ID, As built drawingsseis “sets 10 | List of ali components with referencing 11 P& T process flow 12 Civil foundation dra - 1 2sets 13 Pre installation requirements 2 sets = ra a literature, data sheets and equipment sets catalogues 7 18 Calibration Report of all sensors, controllers, PLC, transmitters, indicators ete. _ 19 “Test certificates of ail material of construction 4.0 Constraints: 5.1 Material of construction: 8. All contact parts: SS 316 with mittor finish 9. All non contact parts: SS 304 with mat finish 10.Gasket/scal/O ring: Food grade 52 Time lines: 15, Response to URS & submission of quotation: Within 2 weeks 16, Delivery of machine: within 2 month of finalization of order 17, Submission of detail design specification & electrical & mechanical drawing: within 3 weeks of order finalization 18. Submission of FAT/SAT specifications: three weeks before FAT 19. 1 & 00 protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) After delivery & successful installation. 6.2 Support: ing program for operator & technical staff has to be included in offer. > [User Requirement Specification. | : | Indian Institute of Integrative | medicines Li Design Qualification Installation Qualification : | Operational Qualification | [| Performance Qualification :_| Stainless Steel | Material of Construction [| Horse Power | Rotation Per Minute i |: | Current Goods Manufacturing | Practices {| Piping and instrumentation diagram |_| Variable frequency drive |_| Programmable logic controller i:_| Human Machine Interface : [Uninterrupted Power Supply |USER REQUIREMENT SPECIFICATIONS (URS) LIQUID STORAGE TANK DOCUMENT NO. ITIM/URS/17 EQUIPMENT ID LI-17 TABLE OF CONTENTS SNe, Particulars Page no. 62._| INTRODUCTION LL | ABOUT THE PROJECT H 12 3 13 5 3 14 EQUIPMENT GENERAL DESCRIPTION z 1.5 | GUIDELINE FOR EQUIPMENT 3 63. OPERATIONAL REQUIREMENT 2.1_| CAPACITY zi a2 PROCESS PARAMETER CONTROL 4 2.3 _| SAFETY FEATURE 4 24 POWER FAILURE & RECOVERY 4 25 CLEANING REQUIREMENT 4 2.6 INPROCESS CONTROL | 4 2:7 [INSTRUMENTATION a 28 SPECIFIC REQUIREMENT z 64, ‘TECHNICAL REQUIREMENT 6 @_| DOCUMENTATION a 66,_| CONSTRAINTS MATERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 6. LIFE CYCLE TI INSPECTION & TESTING 7 62 _| SUPPORT 7 7 GLOSSARY 3 Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 1.66About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state ofart cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for elinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant. For Information 1.67Scope: ‘This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the HIM. For Information 1.68 Purpose: This document was generated under the authority ofthe TIM forthe purpose of specifying the For Information‘user requirement for Liquid storage tank, The system shall be used for storage of Liquid syrup product preparation, 1.69Equipment General Description: ‘The Liquid storage tank will be operated independently of other equipment and systems and will be located ina designated operating aren. Liquidstorage vessel should be vertical cylindrical Machine should have bottom entry propeller stirrer For Information 1.70Guidelines for equipment: The equipment should comply with following guidelines‘standard: Schedule M,WHO &USFDA Guidelines For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 500 It. 22 Process control features: Digital controller/display of: Temperature of product on panel. Weight (Load cell) display on vessel. Speed of stirrer CIP control parameters. 2.3 Safety Features: Following safety features required: 1, Emergency stop funetion 2. Closure of all rotating part 3. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery: Machine settings should not get disturbed due to power failure. Machine should not restart without human intervention, 2.5 Cleaning requirement: All contact parts should be easily dismantled and cleanable, for contact part CIP shall be considered. 2.6 Instrumentation: Following instrumentation is required for process control: ‘ype of control Instrumentation Weight of material Digital weight display Speed of stirrer VED Monitor of temperature Temperature controfler digital Specific requirement: Preferred make of PLC: Mitsubshi /Siemens Preferred make of motor: Crompton/Kirloskar Syrup storage vessel should be vertical ,cylindrical type ‘The syrup storage should have operation panel, control panel Interconnected product piping should be of SS 316 L All bottom valve should be flushed type. Product piping should be orbital welding and electro polished. Vessels should have man hole, light arrangement. Tank should be of $S316 L with 240 grit finish internally and externally $5304 with mat finish. Material transfer pump of suitable capacity along with the product piping of ss316L should be considered for material transfer upto holding vessel of filling and sealing machine ‘The tank should have CIP system, Height of flush bottom valve from ground should be 750mm.Nozzle on vessel: A: Product inlet B: One25 mm spare nozzle . C: Temperature sensor. Specifications Remarks 10.6 Technical requirement: 54, Utilities consumption: A: Blectricity:... ..(Specify by supplier) 55. Vendor should specity weight, size & heat given of machine. 56, Vendor shall provide special tools for maintenance of equipment 57. Industrial plug, cable, air tube is in scope of vendor 58, System security shall be provided to access the operation system(HMI) 59, Arrangement for Batch record printing with necessary parameters (Optional) Documentation: List of all Documents (Not limited to this) tobe supplied along with equipment. Document shall be supplied in hard copy & ele: sh language. Sr. ia to be supplied Qty ‘Remarks No, (3 iperation manual Maintenance manual, type of lubricants, lubrication instruction is Spare parts manual_ Allengineering drawings, nty / _ “10 List of all components with referencing 11__| P&I process flow diagrams 12__|Civi 14 __ Installation requirements _ _ a - 15 Installation manual . 2 sets | 16 | ‘Technical literature, data sheets and equipment 2 sets satalogues DQ, IQ. OQ documents, 1 Bsets i Calibration Report of all sensors, controllers, PLC, 2 sets: transmitters, indicators ete. - | I 19 | Test certificates of all material of construction [sets Constraints: 5.1 Material of construction: All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery of machine: within 2 month of finalization of order Submission of detail design specification &electrical , mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT1Q & OQ protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) After delivery & successful installation. 6.2 Support Training program for operator & technical staff has to be included in offer. Glossary: URS User Requirement Specification. 2. IIIM : | Indian Institute of Integrative medicines DQ Design Qualification 4.19 “Installation Qualification 5 0Q :_ Operational Qualification PQ. | Performance Qualification Ss | Stainless Steel [Moc Material of Construction | 9. HP Horse Power 10. | RPM : | Rotation Per Minute | 11. cGMP /: | Current Goods Manufacturing |__| Practices 12. [PRID _L [Piping and instrumentation diagram _| 13. VFD | Variable frequency drive Programmable logic controller | | Human Machine Interface ‘Uninterrupted Power SupplyINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(694)-11/Pur Dated:4.10.11 Suh.: Purchase ofColloidal Mill Dear Sirs, ‘We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the ‘erms_& conditions giving our tender reference No. and date of opening of Tender in one envelop ‘S.No. | Description of the material Qty T Colloidal oO Detailed Specifications as per Annexure enclosed ‘You are requested to Tumnish your quotation with lieratue” catalogue ele, superseibing quotation for Colloidal Mill” duly mailed by courier spoed post so as to reach on or before 911.2011 upto2.30 PM to the address ofthe Director (Attn Stores & Purchase Oificer), Indian Institute of Integrative Medicine Canal Road, Jansmu-180001.and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives ofthe bidders, if any desire to atend Tender Opening. Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, fay allowed should be mentioned specifically ould be mentioned ia the offer. ‘Tax may also be taken into account while 1 iy: We are exempted for payment of Excise duty and necessary Duty Exemption Certifieate ean be issued accordingly. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid till time of supply ‘60% payment against supply of material at sit (IM Jammu). 20% after installation and sucoessiul commissioning of equipment ‘Special Terms & Conditions \Vender needs to submit their client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith Al venders should fill URS of machineries given along withthe tender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rates is also tobe attached by the supplier with the quotation that the rates quoted to IITM, Jame is not higher than the rates quoted to any other CSIR Laboratory/Insttute or Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should he unambiguous and Terms and Conditions are to he specified clearly, Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, ‘Note: In case the parties want to quote as Tndian agents of foreign su their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed liers, the following terms may be specified in clear terms in Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) COLLOIDAL MILL DOCUMENT NO. IIM/URS/I8 EQUIPMENT NO. PL-18 TABLE OF CONTENTS No. Particulars Page no. ‘67.__| INTRODUCTION L.1__| ABOUT THE PROJECT 3 12 | SCOPE. 3 13__| PURPOSE 3 1.4 | EQUIPMENT GENERAL DESCRIPTION, 3 15 IIDELINE FOR EQUIPMENT 3 68.__| OPERATIONAL REQUIREMENT. 2.1 [CAPACITY 4 2.2 _| PROCESS PARAMETER CONTROL q 2.3_| SAFETY FEATURES: 4 2.4 _| POWER FAILURE & RECOVERY a 2.5_| CLEANING REQUIREMENT a 2.6_ | INPROCESS CONTROL 7 2.7_ | INSTRUMENTATION q 3.6 _| SPECIFIC REQUIREMENT 4 ‘9. | TECHNICAL REQUIREMENT 3 70._| DOCUMENTATION 36 Ti._| CONSTRAINTS MATERIAL OF CONSTRUCTION é MILE STONE & TIMELINES. 6 6,_| LIFE CYCLE G.1__| INSPECTION & TESTING 7 62 | SUPPORT 7 GLOSSARY 78 Vendor Should specify their comments as*Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific ch (CSIR) of India, with primary focus of research on drug discovery from For Information natural products (medicinal plants and microbial species), Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical! herbal deugs and reference standards, drugs for clinical tials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant 1.72Scope: For Information ‘This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide byThe information and conditions set forth by this document as well as the standard purchasing term and conditions of the T1IM. 1.73 Purpose: ‘This document was generated under the authority of the IIM for the purpose of specifying the user requirement for an Colloidal mill. The system shall be used for homogen dispersing, mixing, comminuting of liquid or highly viscous product ing, emulsifying, For Information 1.74Equipment General Description: The colloidal mill will be operated independently of other equipment and systems and will be located in a designated operating area Process steps Product is fed into operating area of rotor by feed device. The product is processed through high sheer, pressure and friction between starter and rotor, the angular gap becomes narrower towards the discharge section, Processed product will leave the mill through the drain pipe if required i can be re cireulated. For Information 1,75Guidelines for equipment: The equipment should comply with following guidelines/standard: Schedule M,WHO & FDA Guidelines For Information Specifications Remarks 2.0 Operational Requirement 2A Capacity/Output:120— 12000 kyshint 2.2 Process control features: Following parameters shall be controlled by machine: 19. Motor RPM 2.3 Safety Features: Following safety features required! 1. Emergency stop function 2. Closure of all rotating part 3. Wherever possible, warning symbols should be provided 24 Power failure & recovery: Machine settings should not get disturbed due to power failure, Machine should not restart without human intervention, 25 Cleaning requirement: All contact parts should be easily dismantled and cleanable 2.6 In process control: Sampling port for inprocess sampling of liquid is required. 2.7 Instrumentation: Following instrumentation is required for process control: ‘ype of control Instrumentation Monitor& control process time foreach | Timer digital operation ‘Monitor & control RPM of motor VED 2.9 Specific requirement: 4, Preferred make of motor: Crompton/Kirloskar 5. Horizontal type 6. All material contact parts should be of S.S. 316 quality material & mirror finished and is crevice free, 7. Vendor should specify Change over time from one product to another product. 8, Neoprene sealing device required between motor & processing Chamber to prevent liquid going in to motor wiring 9. Particle size reduction: 5 to 10 micronSpecifications Remarks 10.7 Technical requirement: 60, Utilities consumption: A: Electicity {Specified by supplier) 61. Vendor should specify weight, size & heat given of machine. 62. Vendor shall provide special tools for maintenance of equipment 63. Industrial plug, cable, isin scope of vendor 63.0 Documentatio List ofall Documenis (Not limited to this) tobe supplied along with equipment. Document shall be supplied in hard copy & electronic edible version in English language. | Sr. Document to be supplied | Qty | Remarks No. T Design and operational qualification Deets 2 SAT/FAT procedures 3 Operation manual 2 sets 2 sets 4 Maintenance manual, type of lubricants, lubrication instruction ‘Spare parts manual _ | 2 sets ‘All engineering drawings, P&ID, As built drawings 2 sets 2 sets 5 6 (7 List of instruments 8 9 2 sets 10 List of aii components with referencing [2 sets Process flow diagrams 12 Pre installation requirements 2 sets ' 13 Installation requirements 2sets (14 Installation manual 2 sets rs | TD sets | i catalogues i i [16 | DQ1Q, OQ documents. - I 2 sets 17 Test certificates of all material of construction sets 5.0 Constraints: 5.1 Material of construction: 11. All contact parts: SS 316 with mirror finish 12.All non contact parts: SS 304 with mat finish 13.Gaskevseal/O ring: Food grade ime lines: 20. Response to URS & submission of quotation: Within 2 weeks 21. Submission of detail design specification & electrical & mechanical drawing: within 3 weeks of order finalization, 8222. Submission of FATISAT specifications: three weeks before FAT 23. 1Q & OQ protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) After delivery & successful installation. 6.2 Support: Training program for operator & technical staff has to be included in offer, 7.0 Glossary: URS T; | User Requirement Specification. Indian Institute of Integrative medicines Design Qualification Installation Qualification Operational Qualification Performance Qualification Stainless Steel Material of Construction Horse Power Rotation Per Minute Current Goods Manufacturing Practices 12, P&ID Piping and instrumentation diagram : | Variable frequency drive 13. VFD 14. PLC “fT | Programmable logic controller | 45. | HMI : | Human Machine Interface ' 16. UPS Uninterrupted Power SupplyINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(695)-11/Pur Dated:4.10.11 Sul Pu ase ofBottle Washing Machine Dear Sirs, We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. S.No. | Description of the material ‘Qty 7 Bottle Washing Machine or Detailed Specifications as per Annexure enclosed ‘You are requested to Turnish your quotation with Inerature’ catalogue ete, superscribing quotation for Bottle Washing Machine™ duly mailed by courier/speed post so as to reach on or before 14.11.2011 upto2.30 PM to the address of the Director (Attn. Stores & Purchase Officer, Indian Institute of Integrative Medicine Canal Road, Jammu-18000 and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives ofthe bidders, if any desire to atend Tender Opening Prices should he quoted on FOR HIM Jammu Discount: Institutional Discount, if any allowed should be mentioned specifically Taxes and Levies: Should be mentioned inthe offer. JAK Entry Tax: Entry Tax may also be taken into account while quoting, Presently Entry Tax is 13.5% Excise Duty: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate ean be issued accordingly. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid til time of supply ‘6% payment against supply of material at site (IM Janinw). 20% after installation and successful commissioning of equipment ‘Soscial Terms & Conditions ‘ender needs to submit their client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith, All venders should fill URS of machineries given along with the ender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rates i also tobe attached! by the supplier with the quotation tha dhe rates quoted to TEM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Insttate or Govt. Organization, ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only ater murual consent / acceptance of HIM & Suppliet. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of faceeptance / rejection of tender is reserved with Director, ITIM, Jamm, Note: - In case the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers, 1. FOB/CIF Price. 2. Country of origin, 3 Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) BOTTLE WASHING MACHINE DOCUMENT NO. ITIM/URS/41 EQUIPMENT ID LI-11 TABLE OF CONTENTS S.No. Particulars Page no. 72.__| INTRODUCTION 1.1 | ABOUT THE PROJECT 3 1.2 | SCOPE 3 13 | PURPOSE 3 14__| EQUIPMENT GENERAL DESCRIPTION 3 LS IDELINE FOR EQUIPMENT 3 73._| OPERATIONAL REQUIREMENT 2.1_[ CAPACITY 4 2.2 _| PROCESS PARAMETER CONTROL 4 2.3_| SAFETY FEATURES 4 2.4 | POWER FAILURE & RECOVERY 4 2.5_| CLEANING REQUIREMENT 4 2.6 _| INSTRUMENTATION 4 2.7_[ SPECIFIC REQUIREMENT 3 7a,_| TECHNICAL REQUIREMENT 6 75.__| DOCUMENTATION 67 76.__| CONSTRAINI MATERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 6._| LIFE CYCL 6.1__ | INSPECTION & TESTING 7 6.2 _ | SUPPORT 7 t (GLOSSARY ‘Vendor Should specify their comments as*Yes” or “No” in remarks column. Specifications Remarks 1.0 INTRODUCTION: 2.1 About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical’ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant For Information 2.2 Scope: This user requirement specification will be recognized as an integral part of the procurement ‘agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the HIM. For Information2.3, Purpose: ‘This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for bottle washing machine. ‘The system shall be sed for washing of bottles, For Information 2.4 Equipment General Description: ‘The bottle washing machine will be operated independently of other equipment and systems and “will be located ina designated operating area. Bottles will load automatically into cup from conveyor. After going through series of wash cycle like air, DM, recycle water bottle got transfer for fling. For Information 2.5 Guidelines for equipment: The equipment should comply with following guidelines‘standar: Schedule M.WHO &USFDA Guidelines For Information Specifications Remarks 2.0 Operational Requirement 21 Capa 80 bottles/min. of 100 ml capacity 2.2 Process control features: 1. Flow sensor for water and air. 2. Monitoring of wash volume 3. water temp, water pressure, air pressure, time, 4, Display of quantity washed 2.3 Safety Feature Following safety features required: 1, Emergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery Machine settings should not gct disturbed due to power failure. Machine should not restart without human intervention, 25 Cleaning requirement: All contact parts should be easily dismantled and cleanable, for contact part CIP shall be considered 2.6 Instrumentation: Following instrumentation is required for process control: ‘Type of control Instrumentation ‘Water temperature ‘Temperature indicator Water & air pressure Pressure gauge Monitor of wash volume Flow meter ‘Number of bottle washed Bottle Counter 2.10 Specific requirement: 10. Preferred make of motor: Crompton/kirloskar 11. Bottle washing capacity should be 80 bottles per minute for 100ml capacity. 12. Bottle should be loaded automatically in to washing machine from conveyor 13, Bottle washing machine should have six washing station(User selectable) and two station may userecycled water. 14. Each cycle should have provision to adjust wash time.(min 2 sec.) 15. External washing of bottle should also be completed in first washes.16. All utility should have interlock 47. Variable frequency drive (VFD) should be considered for speed variation (New added) 18, All contact part should be $5316 19. Recycled water should have appropriate filter 20. Inspection of before and after wash should be provided 21, Bottle washing machine should be able to wash 10 ml bottle to 240m! bottle. Specifications Remarks 10.8 Technical requirement: A Uiltiesconsutnption: AA Election senses Sei by supple) B: Air Pressure... (Specify by supplier) 65, Vendor should specify weight, size & heat given of machine. 66. Vendor shall provide special tools for maintenance of equipment 67. Industrial plug, cable, air tube is in scope of vendor 68, System security shall be provided to access the operation system(HML) 69, Arrangement for printing with necessary parameters (Optional) Documentation: List of all Documents (Not limited to this) to be supplied along with equipment. Document shall be supplied in hard copy & electronic editable version in English language. Sr. Document to be supplied No. _ i i Design and operational qualific 2; SAT/FAT procedures - 3 Operation manual - 4 | Maintenance manual, type of lubricant | instruction pare parts manual | P& I process flow diagrams 12__| Civil foundation drawings - (13 _| Pre installation requirements _— 14 __ | Installation requirements Installation manual 16 | Technical literature, data sheets and equipment | catalogues oe _ | 7 0g. 7 18 | Calibration Report of all sensor ansmitters, indicators ete, 19 | Test certificates of all material of construction | Constraints: 5.1 Material of construction: All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finishResponse to URS & submission of quotation: Within 2 weeks Delivery of machine: within 2 month of finalization of order Submission of detail design specification &electrical , mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT (Site acceptance test) Afier delivery & successful installation. 6.2 Support Training program for operator & technical staff has to be included in offer. Glossary: - L [URS User Requirement Specification. | 2. TIM {_Hndian Institute of Integrative medicines ! 3 [| Design Qualification | 4. [i _Hnstallation Qualification i Operational Qualification Performance Qualification | | Stainless Steel ' Material of Construction { Horse Power Rotation Per Minute Current Goods Manufacturing Practices | | Piping and instrumentation diagram | [| Variable frequency drive { Programmable logic controller i {| Human Machine Interface + [Uninterrupted Power Supply lINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2869028, 2569019, No. 2(698)-11/Pur Dated:4.10.11 Sul Pu ase ofRapid Mixer Granulator Dear Sirs, We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. S.No. | Description of the material ‘Qty 7 Rapid Mixer Granulator or Detailed Specifications as per Annexure enclosed ‘You are requested to Turnish your quotation with Inerature’ catalogue ete. superscribing quotation for Rapid Mixer Granulator™ duly mailed by courier/speed post so as to reach on or before 09.11.2011 upto2.30 PM to the address of the Ditcctor (Attn. Stores & Purchase Officer, Indian Institute of Integrative Medicine Canal Road, Jammu-18000and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives ofthe bidders, if any desire to atend Tender Opening Prices should he quoted on FOR HIM Jammu Discount: Institutional Discount, if any allowed should be mentioned specifically Taxes and Levies: Should be mentioned inthe offer. JAK Entry Tax: Entry Tax may also be taken into account while quoting. Presently Entry Tax. Excise Duty: We are exeimpted for payment of Excise duty and necessary Duty Exemption Certificat Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent aroun valid til time of supply ‘6% payment against supply of material at sit (IM Jamin). 20% after installation and successful commissioning of equipment ‘Soscial Terms & Conditions \Vender needs to submit their client list and at least three successil installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith, All venders should fill URS of machineries given along with the tender document, without proper filling of URS, tenders will not be accepted ‘Validity of rates: A certificate of rates i also tobe attached! by the supplier with the quotation tha dhe rates quoted to HEM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Insttate or Govt. Organization, ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / accepiance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of ‘acceptance / rejection of tender is reserved with Director, IIIM, Jamm, Note: - In case the parties want {o quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms their offers, 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed be issued accordingly Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) RAPID MIXER GRANULATOR (RMG) DOCUMENT NO. IIIM/URS/04 EQUIPMENT ID NO. PT-04 TABLE OF CONTENTS S.No. Particulars Page no. 77._ | INTRODUCTION 1.1 | ABOUT THE PROJECT 3 12 | SCOPE. 3 13__| PURPOSE 3 EQUIPMENT GENERAL DI 3 LS__| GUIDELINE FOR EQUIPMENT. 3 78.__| OPERATIONAL REQUIREMENT 2.1 | CAPACITY 4 2.2 _| PROCESS PARAMETER CONTROL 4 2.3 _| SAFETY FEATURES 4 2.4 | POWER FAILURE & RECOVERY 4 2.5 _| CLEANING REQUIREMENT 4 2.6 _ | INPROCESS CONTROL 4 2.7_ | INSTRUMENTATION 5 3.6 _| SPECIFIC REQUIREMENT 3 79,_| TECHNICAL REQUIREMENT 6 80,__| DOCUMENTATION oT ‘81. | CONSTRAINTS MATERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 6,_| LIFE CYCL G.1_| INSPECTION & TESTING 5 6.2 __| SUPPORT 5 ‘GLOSSARY 89 Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 2.6 About The Project Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species), Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical’ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant, For Information 27 Scope: This use requirement specification will be recognized as an integral part ofthe procurement ‘agreement withthe selected equipment vendor, The equipment supplier or vendor will abide by the information and conditions set forth by this document as well asthe standard purchasing For InformationTerm and conditions of the TIM. 2.8 Purpose: This document was generated under the authority ofthe TIM forthe purpose of specifying the user requirement for an automated granulation system. The system shall be used to perform a granulation step in which active and/or inactive pharmaceutical ingredients are combined with granulation Nui, For Information 2.9 Equipment General Desc! ‘The granulation system will be operated independently of other equipment and systems and witl be located in a designated operating area For Information 2.10Guidelines for equipment: The equipment should comply with following guidelines/standard: Schedule M,WHO &USFDA Guidelines For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 15/30 kg with interchangeable bowl 2.2 Process control features: Following parameters shall be controlled by machine: 20, Impeller & chopper RPM 21, Binder spray rate 22. Total granulation time 23. Provess end point Notification to operator for operational control: 40. Low compressed air 41. Discharge valve open 42, Lid open 2.3 Safety Features: Following safety features required: 1. Emengeney stop function Supporting rails surrounding RMG platform Interlocking of bow! lid & discharge port with limit switeh Closure ofall rotating part .. Wherever possible, warning symbols should be provided when 2.4 Power failure & recovery Machine settings should not get disturbed due to power failure. Machine should not restart without human intervention, 2.5 Cleaning requirement All contact parts should be easily dismantled and cleanable, for contact part CIP shall be considered.for WIP arrangement vendor shall quote extra, 2.6 In process control: Sampling port for inprocess sampling of granules is required. 2.7 Instrumentation: Following instrumentation is required for process control: ‘Type of control Instrumentation Monitor granulation time ‘Timer digital “Monitor wet & mixing time Timer digital ‘Monitor speed of chopper & impeller RPM analyzer “Monitor amperage of chopper &impeller__| Ammeter 2.8 Specific requirement: 1. Preferred make of PLC: Mitsubishi/Siemens2. Preferred make of motor: Crompton/Kirloskar 3. lockable lid/ring from all side of bow! 4. vent filter of lid with clamp attachment 5. view glass 6. VED for impeller & chopper motor 7. 0.2 micron filter for compressed air 8. Noise level below 80 db at a distance of 1 mt. from equipment. 9. Change over time from one product to another product. Specifications Remarks Technical requirement: ilties consumption: A: Electricity: B: Compresses ai:. C: Dust extraction: Specified by supplier) 71. Vendor should specify weight, size & heat given of machine. 72, Arrangement of UPS (Optional) 73, Vendor shal provide special tools for maintenance of equipment 74, Industrial plug, cable, air tube is in scope of vendor 75. System security shall be provided to access the operation system(HMI) 76, Arrangement for Batch record printing with nevessary parameters (Optional) Documentation: {List of all Documents (Not limited to this) tobe supplied along with equipment, Document | shall be supplied in hard copy & electronic editable version in E1 Sr. Document to be supplied No, 1 Design and operational qualification 1D sets 2 SAT/FAT procedures _ 3 Operation manual - 4 Maintenance manual, type of lubricants, lubrication 2sets [instruction 5 Spare parts manual 6 Alfengineering drawings, 2 List of instruments _ P&T process flow diagrams Pre installation requirements Installation requirements catalogues Calibration Report of all Sensors, controllers, PLC, transmitters, indicators ete. 18 Test certificates of all material of construction | 2 sets 19 Test Certificates of software used in machine control / 2 sets monitoring system. Constraints: Material of construction: All contact parts: SS 316 with mirror finish, All non contact parts: SS 304 with mat finishResponse to URS & submission of quotation: Within 2 weeks Delivery: within 2 month of order finalization Submission of detail design specification & electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With deliver 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) Afier delivery & successful installation, 6.2 Support Training program for operator & technical staff has to be included in offer. Glossary: I URS. - [Ts T User Requirement Specification. 2. iM [:Hndian Institute of Integrative medicines Design Qualification | ‘Installation Qualification Operational Qualification Performance Qualification Stainless Steel | | Material of Construction | Horse Power | Rotation Per Minute { Current Goods Manufacturing Practices Piping and instrumentation diagram | Variable frequency drive _[:_| Programmable logic controller :_| Human Machine Interface Uninterrupted Power SupplyINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(696)-11/Pur Dated:4.10.11 Suh.: Purchase ofSifter Dear Sirs, ‘We are interested to purchase the below mentioned items for our research work. You are requested to send us the quotes alongwith the terms & eonditions giving our tender reference No, and date of opening of Tender in one envelop S.No. | Description of the material ‘Qty 7 ifter| or Det: led Specifications as per Annexure enclosed. ‘You are requested to Turnish your quotation with Ineratue”vatalogue ete. superseribing quotation for Sifie™ duly mailed by courieispeed post so asto reach on orbefore9.11.2011 upto2.30 PM. to the address ofthe Director (Attn, Stores & Purchase Officer, Indian Institute of Integrative Medicine Canal Road, Jammu-180001.and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, iF any deste to attend Tender Opening. Prices should he quoted on FOR 111M Jammu Discount: Institutional Discount, ifany allowed should be mentioned specifically Taxes and Levies: Should be mentioned inthe offer. JAK Entry Tax: Entry Tax may also be taken into account while quoting. Presently Entry Tay, Excise Duty: We are exeimpted for payment of Excise duty and necessary Duty Exemption Certfiat. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid till time of supply ‘607% payment against supply of material at site (IM Janam). 20% after installation and successful commissioning of equipment ‘Soscial Terms & Conditions ender needs to submit thei client list and at least three successfil installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, ineluding packing and forwarding charges & prescribed in specified format attached herewith All venders should fill URS of machineries given along with the tender document, without proper filling of URS, tenders will nat be accented Validity of rates: A certificate of rates i also tobe attached! by the supplier with the quotation that dhe rates quoted to TIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Insttate or Govt. Organization, ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only ater murual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of faceeptance / rejection of tender is reserved with Director, {LIM, Jam, Note: - In case the parties want {o quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers, 1. FOB/CIF Price. 2. Country of origin, 3 Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed be issued accordingly. Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) DOCUMENT NO. IIIM/URS/02 EQUIPMENTID PT-02 TABLE OF CONTENTS SNo. Particulars Page no. 82. | INTRODUCTION LL | ABOUT THE PROJECT 3 12 | SCOPE 3 13__| PURPOSE 3 1.4___| EQUIPMENT GENERAL DESCRIPTION 3 15 IDELINE FOR EQUIPMENT 3 33._ | OPERATIONAL REQUIREMENT 2.1_| CAPACITY z 2.2 _| PROCESS PARAMETER CONTROL + 2.3 _| SAFETY FEATURI 7 2.4 _| POWER FAILURE & RECOVERY, a 2.5_| CLEANING REQUIREMENT 4 2.6 _| INPROCESS CONTROL s 2.7_ | INSTRUMENTATION 5 2.8 _| SPECIFIC REQUIREMENT 3 84. | TECHNICAL REQUIREMENT 6 85._| DOCUMENTATION ol 86,_| CONSTRAINTS ‘MATERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 6._| LIFE CYCLE G.1__| INSPECTION & TESTING 3 62 __| SUPPORT 8 GLOSSARY eo Vendor Should specify their comments as*Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 2.11About The Project Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical! herbal drugs and. reference standards, drugs for elinieal trials) manufactured under GMP conditions. For this purpose JD Pharma Consultants is engaged as a project consultant. For Information 2.12Scope: ‘This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by For InformationThe information and conditions set forth by this document as well as the standard purchasing term and conditions of the IIIM. 2.13 Purpose: ‘This document was generated under the authority of the IIM for the purpose of specifying the user requirement fora vibrosifter, The system shall be used for sieving of material For Information 2.14Equipment General Description: “The vibrosifer will be operated independently of other equipment and systems and will be located in a designated operating area, The machine is used for sieving of material for further processing. Process involves following steps: 4, Charging of material in hopper. 5. Undersize material is transferred to lower track through sieve. 66. Finally sieved material is collected in SS container For Information 2.15Guidelines for equipment: For Information The equipmem should comply with following guidelines/standar: Schedule M,WHO GMP. Specifications Remarks 2.0 Operational Requirement e: 20" 2.1 Capacity 2.2 Process control features: Following parameters shall be controlled by machine: 24, Vibration speed 2.3 Safety Feature Following safety features require: 1, Emergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 4, Appropriate failure detection 2.4 Power failure & recovery: In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, or other major utility and will require operator intervention to re-start.After regain of power the equipment should start from the step it stopped. 25 Cleaning requirement: All contact parts should be easily dismantled and cleanable, cleaning shall be done manuall 2.6 In process control: Not applicable 2.7 Instrumentation: Not Applicable 2.8 Specific requirement: 1. Preferred make of motor: Crompton/ Kirloskar 2. lockable wheel arrangement for movement of instrument 3. Noise level below 80 db at a distance of I mt, from equipment. 4, Vendor should mention Change over time from one product to another product 60 Technical requirement: 77. Utilities consumption: A: Blectricitys.... ss(Specily by supplier)78. Vendor should specify weight, size &capacity heat given(Inside room) of machine: 79. Vendor shall provide special tools for maintenance of equipment 80, Industrial plug, cable, air tube isin scope of vendor Documentation: List of all Documents (Not limited to this) to be supplied along with equipment. Document shall be supplied in hard copy & soft copy. Sr. No. Document to be supplied Remarks : [o 2 SAT/FAT procedures 3 Operation manual 4 Maintenance manual, type of lubricants, lubrication instruction, food grade certificate for lubricants _ 5 2 sets 6 Allengineering drawings, P&ID, As built drawings 2 sets struments, set 7 List of i List of all components with referencing process flow diagrams. “Installation manual _ 16 ‘Technical literature, data sheets and equipment catalogues 17 DQ, IQ, OQ and PQ documents. “18 Calibration Report of all sensors, controllers, transmitters, indicators ete. . 19 | Test certificates of all material of construction Constraints: 5.1 Material of construction: All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat fini: Gasket/seal/O ring: Food grade All welds should be ground finished Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Within 2 month of order finalization Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT IQ & OQ protocol: With deliver 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation. 6.2 Support ‘Training program for operator & technical staff has to be included in offer [2] User Requirement Specification. [Indian Institute of Integrative medicines (Design Qualification[.Tnstallation Qualification ‘Operational Qualification | Performance Qualification | Stainless Steel | Material of Construction “Ts Horse Power Rotation Per Minute | [| Current Goods Manufacturing Practices |_| Piping and instrumentation diagram _[: | Variable frequency drive / {| Programmable logic controller Human Machine Interface | Uninterrupted Power SupplINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2569023, 2569019, No. 2(697)-11/Pur Dated:4.10.11 Sub.: Purchase ofRoller Compactor Dear Sirs, ‘We are interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No. and date of opening of Tender in one envelop, S.No. | Description of the material ‘Qty 1 Roller Compactor or Detailed Specifications as per Annexure enclosed ‘You are requested to famish your quotation wi erature” catalogue ete. supersrbing quotation for Roller Compacior™ duly mailed by couriesspeed post sous 1 reach on ge before 09.11.2011 upto2.30 PM. tothe addres of the Director (Attn. Stores & Purchase Ofice, Indian Insiae of Incurative Medicine Canal Road, Jammct80001-and the same will be opened on the same day at 30PM in the presence ofthe ized representatives ofthe bers, if any dsie to attend Tender Opening should be quoted on FOR 11M Jammu Discount: Insuttional Discount, any allowed should be mentioned specially “Taxes and Levies: Should be mentioned in the oe. {H&K Entry Tax: Entey Tax may als be taken into account while quoting. Presently Entry Tax is 13.8% Excise Duty: We are exempted for payment of Excise duty and necessary Duty Exemption Cefcae ean be issued accordingly Delivery: Within the lead-in isthe essence ofthe ender and is to be specifically mentioned in the onde. Payment: 20% advance payment against Bank Guarantee of equialest amount valid tl ime of supply st supply of material at site (TM ammo. 20% aftr installation and successful commissioning of equipment Speci 1 & Conditions \Vender needs to submit their client list and at least three successful installations and operation certificate ftom end users. All Prices quoted should be FOR THM Jammu, including packing and forwarding charges & prescribed in specified format attached herewith All venders should fill URS of machineries given along withthe tender docurnent, without proper filing of URS, tenders will not be accepted. Validity of rates: A certificate of rate i also tobe attached by the supplier with the quotation that the rates quoted to TIIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Tnstitute oF Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to he specified clearly. Right of acceptance / rejection of tender is reserved with Director, ITTM, Jammu, Note: ~ In case the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers. 1. FOB/CIF Price. 2. Country of origin, 3 Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed ‘Yours faithfully, Stores & Purchase OfficerER REQUIREMENT SPECIFICATIONS (URS) ROLLER COMPACTOR ‘DOCUMENT NO. HIM/URS/03 EQUIPMENT ID PT-03 TABLE OF CONTENTS SNe. Particulars Page no. ‘87.__| INTRODUCTION 1.1 | ABOUT THE PROJECT 3 12 | SCOPE 3 13 | PURPOSE 3 14 __| EQUIPMENT GENERAL DESCRIPTION 3 1.S__| GUIDELINE FOR EQUIPMENT 3 ‘38._| OPERATIONAL REQUIREMENT 2.1 _| CAPACITY 4 2.2 _| PROCESS PARAMETER CONTROL. r 2.3_| SAFETY FEATURES r 2.4 | POWER FAILURE & RECOVERY 4 2.5 _| CLEANING REQUIREMENT 4 2.6 _| INPROCESS CONTROL 3 2.7_ | INSTRUMENTATION 3 2.8 _| SPECIFIC REQUIREMENT s 89,__| TECHNICAL REQUIREMENT 6 90,_| DOCUMENTATION ol 91, CONSTRAINTS MATERIAL OF CONSTRUCTION ‘MILE STONE & TIMELINES 6._ [LIFE CYCLE 6.1___[ INSPECTION & TESTING 7 6.2 | SUPPORT 7 7. 78 Vendor Should specify their comments as“Yes” or “No” in remarks column. Specifications Remarks 1.0 INTRODUCTION 2.16About The Project Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Couneil of Scientific ‘& Industrial Research (CSIR) of India, with primary focus of research on drug discovery from | For Information natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state ‘of art cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for smal] and medium manufactures to get their products (botanical’ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this, purpose J D Pharma Consultants is engaged as a project consultant. 2.17Scope: For Information This user requirement specification will be recognized as an integral part ofthe procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing, term and conditions of the HIM.2.18 Purpose: This document was generated under the authority ofthe IM forthe purpose of specifying the set requirement fora roller compactor. ‘The system shall be used to perform a. compaction8& size reduction of granules. For Information 2.19 Equipment General Description: The roller compacting system will be operated independently of other equipment and systems and will be located in a designated operating arca, Roller compactor system shall use for ‘compacting & size reduction of granules. A typical compaction process involves the following steps: 6. Charging of powder in feeding assembly 7. After reaching powder in compaction head it get compacted and formed into ribbon, 8. After compaction head compact powder passes through granulation unit to provide desired shape & size of granule 9 Granules are collected in container For Information 2.20Guidelines for equipment: ‘The equipment should comply with following guidelines/standard: Schedule M,WHO For Information ‘Vendor Should specify their comments as“Yes” or “No” in remarks column. Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 20 kg/hr 2.2 Process control features Following parameters shall be controlled by machine: 25. Gap Adjustment control 26. RPM of roller 27. RPM of rotoR 28. RPM of screw feeder 29, Atomizing pressure Notification to operator for operational control: 43, Motor over load 44, Motor tipped 23 Safety Features: Following safety features required: 1. Emergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery: In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, or other major utility and will require operator intervention to re-start.After regain of power the equipment should start from the step it stopped 25 Cleaning requirement: All contact parts should be easily dismantled and cleanable, cleaning shall be done manually 2.6 In process control: Manual sampling for inproce: sidered sampling shall be cor 2.7 Instrumentation Following instrumentation is required for process control: Purpose Instrumentation Monitor RPM of roller &rotar RPM indicator with controller“Monitor RPM of feeder RPM indicator Monitor motor load Over load relay 2.8 Specific requirement: 1, Roller gap shall be controlled 2. Roller surface shall be grooved type 3. view port in hopper 4. Noise level below 80 db at a distance of 1 mt. from equipment. 5. Vendor should mention Change over time from one product to another product 109 ‘Technical requirement: 81, Utilities consumption: A: Blectricty (Specify by supplier) 82. Vendor should specify weight, size &capacity heat given(Inside room & exhaust) of machine. 83, Vendor shall provide special tools for maintenance of equipment 84, Industrial plug, cable, air tube is in scope of vendor Documentation: List of all Documents (Not limited to this) tobe supplied along with equipment. Document ul i 2 SAT/FAT procedures - 3 Operation manual '4 Maintenance manual, type of lubricants, lubrication 2 sets | in od grade [Spare parts manual _ All engineering drawings, P&ID, As built drawings 9 | Warranty / Guarantee 10 List of all components with referencing 13 14__| Installation requirements 15 Installation manual oO 16 | Technical literature, data sheets and equipment catalogues 17 DQ, 1Q, 00 document _ 18 | Calibration Report of all sensors, controllers, transmitters, indicators ete, 19 Test certificates of all material of construction Constraints: Material of construction: All contact parts: $S 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade All welds should be ground finished Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Within two month of order finalizationSubmission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization, Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With deliver 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation. 6.2 Support Training program for operator & technical staff has to be included in offer. {User Requirement Specification. Indian Institute of Integrative | medicines | Design Qualification Installation Qualification | : | Operational Qualification [| Performance Qualification | Stainless Steel Material of Construction | Horse Power Rotation Per Minute Current Goods Manufacturing Practices 3! Piping and instrumentation diagram i. Variable frequency drive | Programmable logic controller Human Machine Interface | | Uninterrupted Power SupplyINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2869028, 2569019, No. 2(699)-11/Pur Dated:4.10.11 iin Blender Dear Sirs, We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No. and date of opening of Tender in one envelop. S.No. | Description of the material ‘Qty 7 Bin Blender or Detailed Specifications as per Annexure enclosed ‘You are requested to Turnish your quotation with Ieralue” catalogue ete, superscribing quotation for Bin Blender" duly mailed by eourierspeed post so as 1 reach on or before 09.11.2011 upto?.30 PM. to the address ofthe Director (Attn. Stores & Purchase Ofiver), Indian Institue of Integrative Medicine Canal Road, Jammu-180001 and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, sf any deste to attend Tender Opening. Prices should he quoted on FOR 111M Jammu Discount: Institutional Discount, ifany allowed shouldbe mentioned specifically Taxes and Levies: Should be mentioned inthe offer. JRK Entry Tax: Entry Tax may also be taken into account while quoting. Presently Entry Tax. Excise Duty: We are exeimpted for payment of Excise duty and necessary Duty Exemption Certifiat. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid till time of supply ‘60% payment against supply of material at site (IM Jammu). 20% after installation and successful commissioning of equipment ‘Soscial Terms & Conditions \Vender needs to submit their client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, ineluding packing and forwarding charges & prescribed in specified format attached herewith All venders should fill URS of machineries given along with the tender document, without proper filling of URS, tenders will nat be accented. Validity of rates: A certificate of rates i also tobe attached! by the supplier with the quotation that dhe rates quoted to TIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory’ Institute or Govt. Organization, ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only ater murual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of faceeptance / rejection of tender is reserved with Director, {LIM, Jam, Note: - In case the parties want (o quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms their offers, 1. FOB/CIF Price. 2. Country of origin, 3 Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed be issued accordingly, Yours faithfully, Stores & Purchase OfficerER REQUIREMENT SPECIFICATIONS (URS) BIN BLENDER DOCUMENT NO. ITIM/URS/0S EQUIPMENT ID NO. PT-05 TABLE OF CONTENTS Particulars Page no. ‘92. | INTRODUCTION L.1__ | ABOUT THE PROJECT 3 1.2 | SCOPE 3 13 | PURPOSE 3 14 | EQUIPMENT GENERAL DESCRIPTION, 3 LS | GUIDELINE FOR EQUIPMENT. 3 93,__| OPERATIONAL REQUIREMENT 2.1 | CAPACITY 4 2.2 _| PROCESS PARAMETER CONTROL 4 2.3_| SAFETY FEATURES 4 2.4 | POWER FAILURE & RECOVERY 4 72.5 _| CLEANING REQUIREMENT 4 2.6 | INPROCESS CONTROL. 3 2.7_ | INSTRUMENTATION 5 2.8 _| SPECIFIC REQUIREMENT 3 ‘94, | TECHNICAL REQUIREMENT 6 95._| DOCUMENTATION eT 96. S IAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 i. _| LIFE CYCLE G.1__| INSPECTION & TESTING 3 6.2 | SUPPORT 5 7. ‘GLOSSARY co) Vendor Should specify their comments as*Yes” or “No” in remarks column Specifications Remarks 1,0 INTRODUCTION: 2.21About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state ofart cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for smal] and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant. For Information 2.22Scope: ‘This user requirement specification will be recognized as an integral part of the procurement For Information‘agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the IIIM. 2.23 Purpose: ‘This document was generated under the authority of the IIM for the purpose of specifying the user requirement fora Bin blender. The system shall be used for blending of dry powder granules for manufacturing of tablet For Information 2.24Equipment General Description: ‘The Bin Blender machine will be operated independently of other equipment and systems and will be located ina designated operating area. The machine is used for blending of dry powderidry granules for manufacturing of tablets, Process involves following steps 7. Powder'granules shall be charge in bin after sizing, 8. Blender RPM & process time parameter shall be set in machine, 9, After completion of process, blender will return in upright position & stops. For Information 2.25Guidelines for equipment: The equipment should comply with following guidelines‘standard: Schedule M,WHO GMP For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capaci + interchangeable bin size of 5,10,15,30 kg 2.2. Process control features: Following parameters shall be controlled by machine: 30. Setting of process time(Blending time) 31. RPM 23 Safely Feature Following Safety features require: 1, Emengeney stop function 2. Closure ofall rotating par 3, Wherever possible, warning symbols should be provided 4, Appropriate safety barrier should be placed. if barrier is opened machi stopped. shall 24 Power failure & recovery: In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, or other major utility and will require operator intervention to re-start.After regain of power the equipment should start from the step it stopped. 2.5 Cleaning requirement: All contact parts should be easily dismantled and cleanable, cleaning shall be done manually, 2.6 In process control: Manual sampling 2.7 Instrumentation: Following instrumentation is required for process control: Purpose Instrumentation RPM Controller RPM indicator cum controller Process time Timer with memory backup 2.8 Specific requirement: 1. Preferred make of motor: Crompton/ Kirloskar 2. Dual speed motor (to facilitate dual RPM) 3. Alarm for process end. 2. Noise level below 80 db at a distance of 1 mt. from equipment.4. Vendor should mention Change over time from one product to another product 9.0 Technical requirement: 85, leotiity (Specify by supplier) 86, Vendor should specify weight, size &capacty heat given( Inside room) of machine 87._ Vendor shall provide special tools for maintenance of equipment 88. Industrial plug cable, air tube isin seape of vendor Documentation [List of all Documents (Not limited to this) to be supplied along with equipment. Document shall be supplied in hard copy & soft copy. Sr. ent to be supplied Quy ‘Remarks No. a - 1 Design and operational qualification 2 SAT/FAT pr - 3 [Operation manual “4 Maintenance manual, type of lubricants, lubrication ' | instruction, food grade certificate for lubricants _ 5 Spare parts manual | Dsets [6 __| All engineering drawings, P&ID, As built drawings | 2 sets _ 7 List of instruments _ - - 2 sets 8 i [2 sets, 9 iz [process flow diagrams a Civil foundation drawings (if applicable) 14 Installation requirements - 15 Installation manual 16 | Technical literature, data sheets and equipment catalogues 17 DQ. 10, 09 document a 18 Calibration Report of all sensors, controllers, transmitters, indicators ete. ee 19 Test certificates of all material of construction. Constraints: 5.1 Material of construction: All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade All welds should be ground finished Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Within two month of order finalization Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With deliver 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation,6.2 Support: Training program for operator & technical staff has to be included in offer [21 User Requirement Specification. [:__ndian Institute of Integrative medicines ‘Design Qualification Installation Qualification | {2 Operational Qualification {2 _| Performance Qualification | Stainless Steel Material of Construction Horse Power Rotation Per Minute [| Current Goods Manufacturing Practices Piping and instrumentation diagram Variable frequency drive | [2 _| Programmable logic controller L | Human Machine Interface [5 | Uninterrupted Power Supply !INDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (11 Lines) Telefax: 2569023, 2569019, No. 2(700)-11/Pur Dated:4.10.11 Pu Dear Sirs, fill ‘We ate interesed to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No, and date of opening of Tender in one envelop S.No. _| Description of the material Qty 1 ‘Cone Mill 1 Detailed Specifications as per Annexure enclosed ‘You are requested to Turnish your quotation with Inerature” catalogue ete, superscribing quotation for Cone Mill” duly mailed by courierspeed post Sos t reach on or before 09.11.2011 upto2.30 PM. to the address ofthe Director (Atta, Stores & Purchase Office, Indian Institute of Integrative Medicine Canal Road, Jammu-18000L-and the same will be opened on the same day at 3.30PM in the presence ofthe authorized representatives of the bidders, ifany desire to attend Tender Opening. Prices should be quoted on FOR 111M Jammu Institutional Discount, ifany allowed should be mentioned specifically ould be mentioned in the offer. account while quoting, Presently Entry Tax is 13.5% Excise Duty: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate can be issued accordingly. Delivery: Within the lead-time isthe essence ofthe order and isto be specifically mentioned in the order. Payment: 20°% advance payment against Bank Guarantee of equivalent amount valid tll ime of supply ‘60% payment against supply of material at site (TIM Jammu). 20% after installation and successful commissioning of equipment pecial Terms & Conditions ender needs to submit their client list and at Icastthroe successful installations and operation cemiicate from end users. All Prices quoted should be FOR THM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith, All venders should fill URS of machineries given along with the tender document, without proper filing of URS, tenders will not be accepted. Validity of rates: A cerificate of rates i also to be attached by the supplier with the quotation that the rates quoted to IIIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory‘Tnstitute oF Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only afer mutual consent / acceptance of IIIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to he specified clearly, Right of acceptance / rejection of tender is reserved with Director, ITTM, Jammu, ‘Note: - In ease the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in thelr offers. 1. FOB/CIF Price. 2. Country of origin, 3 Shipping details, 4. Ageney commission if any. Other terms & Conditions as per Annexure enclosed ‘Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) CONE MILL DOCUMENT NO. IIIM/URS/06 EQUIPMENT ID NO. PT-06 TABLE OF CONTENTS S.No. Particulars Page no. ‘97._| INTRODUCTION 1.1 | ABOUT THE PROJECT 3 1.2 | SCOPE 3 13 | PURPOSE 3 14__| EQUIPMENT GENERAL DESCRIPTION, 3 1.5 | GUIDELINE FOR EQUIPMENT 3 ‘98.__| OPERATIONAL REQUIREMENT 2.1 | CAPACITY a 2.2 _| PROCESS PARAMETER CONTROL 4 2.3__| SAFETY FEATURES 4 2.4 | POWER FAILURE & RECOVERY 4 2.5 _| CLEANING REQUIREMENT 4 2.6 _ | INPROCESS CONTROL, 3 2.7_| INSTRUMENTATION 5 2.8 _| SPECIFIC REQUIREMENT 5 ‘99._| TECHNICAL REQUIREMEN 6 100, _| DOCUMENTATION 67 101._| CONSTRAINTS MATERIAL OF CONSTRUCTION, 7 MILE STONE & TIMELINES 7 6,_| LIFE CYCLE 6.1 __ | INSPECTION & TESTING 8 6.2__| SUPPORT 8 7 ‘GLOSSARY 59 Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 2.26About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific ‘& Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state ‘of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for smal] and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant. For Information 2.27Scope: ‘This user requirement specification will be recognized as an integral par ofthe procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well asthe standard purchasing term and conditions ofthe ITIM. For Information 2.28 Purpose: This document was generated under the authority of the IIIM for the purpose of specifying the For Information"user requirement for a Cone mill, The system shall be used For sizing of material 2.29E quipment General Description: The cone mill machine will be operated independently of other equipment and systems and will be located ina designated operating area. The machine is used for sizing of material for manufacturing of tablets. Process involves following steps: 10. Power/gramules shall be charge in cone mil 11, In conical mill chamber vertex low pattern of in feed material occurred due to impeller action, 12. After passing through screen material shall discharged from bottom of chamber. For Information 2.30Guidelines for equipment ‘The equipment should comply with following guidelines/standard Schedule M,WHO GMP For Information Specifications Remarks 2.0 Operational Requirement 21 Capa ‘The machine should be capable of size reduetion ofthe produet granules of up to 250 Kg /Hourin 10 diameter mesh. 2.2. Process control features: Following parameters shall be controlled by machine: 32. Blade RP 23 Safety Features: Following safety features required: 1. Emergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery: In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, or other major utility and will require operator intervention to re-start.After regain of power the equipment should start from the step it stopped. 25 Cleaning requirement: All contact parts should be easily dismantled and cleanable, cleaning shall be done manually, 2.6 In process control: Manual sampling 2.7 Instrumentation: Following instrumentation is required for process control: Purpose Instrumentation RPM Controller for blade RPM indicator cum controller ‘Monitor load on motor due to product Overload relay 2.8 Specific requirement: 1. Preferred make of motor: Crompton/ Kirloskar 2. wheel for mobility of instruments 2. Noise level below 80 db at a distance of 1 mt. from equipment. 4, Vendor should mention Change over time from one product to another product‘Technical requirement: A: Electricity: (Specify by supplier) 90. Vendor should specify weight, size &capacity Jheat given(Inside room) of machine, 91. Vendor shall provide special tools for maintenance of equipment 92, Industrial plug, cable, air tube isin seope of vendor Documentation List of all Documenis (Not limited to this) to be supplied along with equipment. Document hall be supplied in hard copy & soft copy. Document to be supplied Ope - 4 ‘Maintenance manual, type of lubricants, lubi instruction, food grade certifi bri Spare parts manual 11 process flow diagrams (12 Civil foundation drawings (if applicable | | 13 Pre installation requirements - | 14 | Installation requi _ 15 Installation manual_ — i 16 Technical literature, data sheets and equipment 2 sets 7 [Di - 18 transmitters, indicators ete. 19 ‘Test certificates of all material of construction Constraints 5.1 Material of construction: All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade All welds should be ground finished Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: within two month of order finalization ‘Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With deliver 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation. 6.2 Support ing program for operator & technical staff has to be included in offerUser Requirement Specification, + | Design Qualification [2 | Installation Qualification | Indian Institute of Integrative medicines | Operational Qualification Performance Qualification | Stainless Steel Material of Construction | Horse Power Rotation Per Minute Current Goods Manufacturing Practices | Piping and instrumentation diagram | Variable frequency drive {Programmable logic controller Human Machine Interface Uninterrupted Power SupplyINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Telefax: 2569023, 2569019, No. 2(701)-11/Pur Dated:4.10.11 ‘Sub.: Purchase ofFluid Bed Dryer Dear Sirs, ‘We ate interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No. and date of opening of Tender in one envslop. ‘S.No. | Description of the material Qty T Fluid Bed Dryer oO Detailed Specifications as per Annexure enclosed ‘You are requested to Tumish your quotation with Iieratue” catalogue ete, superseribing quotation for Fluid Bed Dayer™ duly mailed by courier/spoed post so as to reach on or before 09.11.2011 upto2.30 PM. to the address ofthe Director (Attn. Stores & Purchase Officer), Indian Institute of Integrative Medicine Canal Road, Jammu-180001.and the same will be opened on the same day at 3.30PM. in the presence ofthe authorized representatives of the bidders, if any desire to atend Tender Opening. Prices should be quoted on FOR 111M Jammu Discount: Institutional Discount, fany allowed should be mentioned specifically ould be mentioned ia the offer. ‘Tax may also be taken into account while Entry Tax is 13.5% iy: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate can be issued accordingly Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned inthe order. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid tll time of supply ‘60% payment against supply of material at site (IM Jammu). 20% after installation and sucoessiul commissioning of equipment ‘Special Terms & Conditions Vender needs to submit their client list and at least three successful installations and operation certificate from end users. All Prices quoted should be FOR TIM Jamma, including packing and forwarding charges & prescribed in specified format attached herewith Al venders should fill URS of machineries given along withthe tender document, without proper filling of URS, tenders will not be accepted Validity of rates: A certificate of rates is also tobe attached by the supplier with the quotation that the rates quoted to ITM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Insttute or Govt. Organization ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should he unambiguous and Tens and Conditions are o be specified clearly. Right of acceptance / rejection of tender is reserved with Director, ITIM, Jammu, ‘Note: - In case the parties want to quote as Indian agents of foreign supplies, the following terms may be specified in clear terms in their offers. 1. FOB/CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) FLUID BED DRYER (FBD) DOCUMENT NO. ITIM/URS/07 EQUIPMENT NO. 07 TABLE OF CONTENTS No. Particulars Page no. 102,_| INTRODUCTION LL | ABOUT THE PROJECT 3 12 | SCOPE. 3 13__| PURPOSE 3 1.4 | EQUIPMENT GENERAL DESCRIPTION, 3 15 IIDELINE FOR EQUIPMENT 3 103._| OPERATIONAL REQUIREMENT. 2.1 [CAPACITY q 2.2 _| PROCESS PARAMETER CONTROL q 2.3_| SAFETY FEATURI 7 2.4 _| POWER FAILURE & RECOVERY a 2.5_| CLEANING REQUIREMENT a 2.6_ | INPROCESS CONTROL 5 2.7_ | INSTRUMENTATION 3 2.8 _| SPECIFIC REQUIREMENT 3 104,_| TECHNICAL REQUIREMENT 6 105._| DOCUMENTATION oF 106. _| CONSTRAINTS MATERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES. 7 6,_| LIFE CYCLE G.1__| INSPECTION & TESTING 3 62 | SUPPORT z GLOSSARY co) Vendor Should specify their comments as*Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 2.31About The Project Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from | For Information natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state of art eGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical! herbal drugs and. reference standards, drugs for elinieal trials) manufactured under GMP conditions. For this purpose JD Pharma Consultants is engaged as a project consultant. 2.32Scope: For Information ‘This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide byThe information and conditions set forth by this document as well as the standard purchasing term and conditions of the IIIM. 2.33 Purpose: ‘This document was generated under the authority of the IIM for the purpose of specifying the user requirement for an fluid bed drier system, The system shall be used to perform a drying. step of granules For Information 2.34Equipment General Description: ‘The FBD system will be operated independently of other equipment and systems and will be located in a designated operating area A typical Dry Process involves the following steps. 1. Preheat (to prevent product from sticking to sides of fluid bed) 2. Loading 3. Drying (Fluidizing) 4. Cool down (Heat off) 5. Unloading The unit should consist of following: 3. PLC to control batch operation. 4. Tower with inlet air supply, fiter housing, container expansion chamber 5. ANU with HEPA filter supply For Information 2.35Guidelines for equipment: ‘The equipment should comply with following guidelines‘standard: Schedule M,WHO For Information Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 30 kg 2.2 Process control features: Following parameters shall be controlled by machine: 33. Inlet air temperature 34. Filter chamber differential pressure 35. Product sereen differential pressure 36, Exhaust air temperature 37. Process end point 38, Product bed temperature Notification to operator for operational control: 45, Powder leakage 2.3 Safety Features: ‘ollowing Safety features required: 1 Emergency stop function 2. Machine should be explosion proof with ant state arrangement 3. Imerlocking of bowl lid & discharge port with limit switch 4, Closure ofall stating part ‘5. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery: In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, air or other major utility and will require operator intervention to re-start After regain of power the equipment should start from the step it stopped 25 Cleaning requirement:All contact paris should be easily dismantled and cleanable, for contact part manual cleaning shall be considered.for WIP arrangement vendor shall quote extra. 2.6 In process control: Manual sampling for inprocess sampling shall be cor sidered 2.7 Instrumentation: Following instrumentation is required for process control: Purpose Instrumentation Monitor & control Pressure in chamber | Pressure gauge “Monitor humidity of inlet ait Hygrometer “Monitor product temperature Temperature indicator (Digital) “Monitor the exhaust air temperature. Digital Temperature indicator Monitor and control the inlet air Temperature indicator (Digital) cum temperature. controller ‘Monitor and control air flow rate Flow rate indicator 2.8 Specific requirement: 1. Preferred make of PLC: Mitsubishi/Siemens 2. Preferred make of motor: Crompton/Kirloskar AHU with HEPA filter arrangement for air supply, arrangement for HEPA filter integrity test should be considered..AHU can be place on service floor. 4, Steam can be used for heating purpose 5. Equipment must be explosion proof with antistatic arrangement 6. Shaking arrangement for product filter bag 7. Arrangement should be included for Solid flow monitor/broken bag detector 8. Equipment should be with flame proof construction 9. Provision for spray gun attachment should be considered 5. view glass 8. Noise level below 80 db at a distance of | mt, from equipment. 9. Vendor should mention Change over time from one product to another product Specifications Remarks 5.0 Technical requirement: 93. Utilities consumption: A: Blectticity........ -+s--n(Specify by supplier) B: Compresses air: (Specify by supplier) C: Steam: (Specify by supplier) D: Chilled waters... (Specify By supplier) 94, Vendor should specify weight, size capacity of machine. 95, Arrangement of UPS (Optional) 96, Vendor shall provide special tools for maintenance of equipment 97. Industrial plug, cable, air tube is in scope of vendor 98. System security shall be provided to access the operation system(HMI) 99. Arrangement for Batch record printing with necessary parameters (Optional) Documentation: List of all Documents (Not limited to this) tobe supplied along with equipment. Document shall be supplied in hard copy & soft copy. Sr. | Document to be supplied Qty 7 Remarks LNo. 7 - - - L 1 Design _ | 2 [SAT/FAT procedures 4 ainten: type tabi i instruction, food grade certificate for lubricants 5 Spare parts manual 6 | Allengineering drawings, P&ID, AS built drawings | 2 setsseis seis TO List of all components with referencing 1 2sets u rocess flow diagrams - 2 sets 12 13__| Pre installation requi ci 14 Installation requirements - [Deets 15 Installation manual - | 2 sets 16 ‘Technical literature, data sheets and equipment 2sets catalogues ia 1 Calibration Report of all sensors, controllers, PLC, “transmitters, indicators ete. 19 “Test certificates of all material of construction, approval 2 sets, certificate of filter bag for antistatic & pore size. Constraints: Material of construction: All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade EBD sieve frame: Silicon Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: within two month of order finalization Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT 1Q & 0Q protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT(Site acceptance test) after delivery & successful installation, 6.2 Support Training program for operator & technical staff has to be included in offer. {User Requirement Specification Indian Institute of Integrative m [| Design Qualification [:“Mnstallation Qualification | Operational Qualification Performance Qualification Stainless Steel Material of Construction | Horse Power ' Rotation Per Minute Current Goods Manufacturing Practices | - |_| Piping and instrumentation diagram [:_| Variable frequency drive _ [| Programmable logic controller [Human Machine Interface ines || Uninterrupted Power SupplyINDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: 0191-2569000, 2569001, to 10 (1 Lines) Teletax: 2569023, 2569019, No. 2(702)-11/Pur Dated:4.10.11 turchase ofTablet Compressiot ‘We ate interesed to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms_& conditions giving our tender reference No. and date of opening of Tender in one envelop, [ S.No. | Description of the material Qty 1 ‘Tablet Compression ‘Mentioned against Detailed Specifications as per Annexure enclosed each ‘equipment ‘You are requested to furish your quotation with Iterature! catalogue ete. superscribing quotation for Tablet Compression” daly mailed by coutier/spoed post so as to reach on or before 14.11.2011 upta2.30 PM. to the address ofthe Dieector (Attn. Stores & Purchase Officer), Indian Instiate of Integrative Medicine Canal Road, Jammu-180001.and the same will be opened on the same day at 3.30PM_in the presence ofthe authorized representatives of the bidders, i any deste to atend Tender Opening. Prices should be quoted on FOR HIM Jammu Discount: Institutional Discount, ifany allowed should be mentioned specifically ‘Taxes and Levies: Should be mentioned in the offer. Entry Tax i count while quoting, Presently Ent Excise Duty: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate ean be issued accordingly. Delivery: Within the lead-time isthe essence ofthe order and isto be specifically mentioned inthe onder. Payment: 20% advance payment against Bank Guarantee of equivalent amount valid ill Gime of supply (60% payment against supply of material at site (IIM Jammu, 20% after installation and successful commissioning of equipment pecal Terms & Conditions Vender needs to submit their client list and at least three successful installations and operation cemificate from end users. All Prices quoted should be FOR TIM Jammu, including packing and forwarding charges & prescribed in specified format attached herewith All venders sould fill URS of machineries given long with the ender document, without proper filling of URS, tenders will not be accepted, Validity of rates: A certificate of rates is ulso tobe attached by the supplier with the quotation that dhe rates quoted to LIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory’Institute or Govt. Organization, ‘Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, ifany, can be made applicable only after mutual consent / acceptance of HIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of Aceeplance / rejection of tender is reserved with Director, ITIM, Jamme, Note: - In ease the parties want (o quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers. 1. FOB/CIF Price. 2. Country of origin, Shipping details, 4. Agency commission Other terms & Conditions as per Annexure enclosed Yours faithfully, Stores & Purchase OfficerUSER REQUIREMENT SPECIFICATIONS (URS) TABLET COMPRESSION MACHINE DOCUMENT NO. IIM/URS/08 EQUIPMENT ID NO. 08 TABLE OF CONTENTS SNe, Particulars Page no, 107, INTRODUCTION [L_| ABOUT THE PROFECT 3 12 | SCOPE 3 13 [ PURPOSE, 3 1 EQUIPMENT GENERAL DESCRIPTION 3 1.5 | GUIDELINE FOR EQUIPMENT 3 108,_| OPERATIONAL REQUIREMENT 2.1 | CAPACITY z 2.2 | PROCESS PARAMETER CONTROL a 2.3 _| SAFETY FEATURES 4 2.4 | POWER FAILURE & RECOVERY 4 2.5 CLEANING REQUIREMENT 4 2.6 INPROCESS CONTROL s 2.7__| INSTRUMENTATION 5 28 SPECIFIC REQUIREMENT 5 109, | TECHNICAT, REQUIREM z 110. | DOCUMENTATION 67 T1i,_[ CONSTRAINTS ERIAL OF CONSTRUCTION 7 MILE STONE & TIMELINES 7 6. LIFE CYCLE 61 INSPECTION & TESTING 7 62 | SUPPORT 7 7. GLOSSARY 8 Vendor Should specify their comments as“Yes” or “No” in remarks column Specifications Remarks 1.0 INTRODUCTION: 2.36About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific ‘& Industrial Research (CSIR) of India, with primary focus of research on drug discovery from For Information natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state ‘of art cGMP compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for smal] and medium manufactures to g reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant. ‘their products (botanical/ herbal drugs and 2.37Scope: ‘This user requirement specification will be recognized asan integral part ofthe procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this dacument as well asthe standard purchasing term and conditions ofthe ITIM. For Information 2.38 Purpose: For Information This document was generated under the authority of the IIIM for the purpose of specifying the‘user requirement for a Tablet compression machine, ‘The system shall be used to forming oF tablets, 2.39Equipment General Description: The compression system willbe operated independently of ether equipment and systems and will be located in designated operating aea. The machine is used for compression of granules for formation of compressed tablet. For Information 2.40Guidelines for equipment: “The equipment should comply with following guidelines/standard: Schedule M,WHO GMP For Information Please mention Yes/no against each specification in remarks column Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 16 station, output 16000-40000 tablethr 2.2 Process control features: Following parameters shall be controlled by machine: 39. Speed of turret 40. Speed of feeder 41, Pre compression force 42. Compression force 43, Automatic weighing checks (Optional) 2.3 Safety Features: Following safety features required! 1 nergency stop function 2. Closure ofall rotating part 3. Wherever possible, warning symbols should be provided 4. Appropriate failure detection 2.4 Power failure & recovery: In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, or other major utility and will require operator intervention to re-start.After regain of power the equipment should start from the step it stopped 25 Cleaning requirement: All contact parts should be easily dismantled and cleanable, cleaning shall be done manually 2.6 In process control: Manual sampling for inprocess sampling shall be considered, Auto weighing check system (Optional) 2.7 Instrumentation: Following instrumentation is required for process control: Purpose Instrumentation Monitor compression force Pressure gauge Monitor number of compressed tablet Counter RPM RPM meter 2.8 Specific requirement: 1. Preferred make of motor: Crompton Kirloskar 2. Preferred make of PLC: Siemens/Mitsubishi 3. Should synchronize with Online de dusting/de burring with metal detection system 4, Dust collection system 5. All type of tooling shall be provided 6. Noise level below 80 db ata distance of | mt. from equipment.7. Vendor should mention Change over time from one product to another product A: Blectricitys 0. (Specify by supplier) B: Dust Extraction: (Specify by supplier) 101. Vendor should specify weight, size &capacity ,heat given(Inside room) of machine. 102. Vendor shall provide special tools for maintenance of equipment 103.Industrial plug, cable, air tube is in scope of vendor 104. Arrangement of UPS (Optional) 105.Batch record printing with all necessary parameters (Optional) 106.System security shall be provided to access operating system(HMI) Documentation: List of all Documents (Not limited to this) to be supplied along with equipment. Document shall be supplied in hard copy & soft copy. St, Document to be supplied Qty | Remarks No. _ T ign and operatio - ~T 2set 2 SAT/FAT procedures 2 sets 3 Operation manual 4 Jaintenance manual, type of lubricants, instruction, food grade certificate for lubricants _ Spare parts manual : 8G 9 | Warranty / Guarantee - - 10 List of all components with referencing u 12 13 Pr qui 14 __| Installation requirements 15 Installation manual_ - oe 16 Technical literature, data sheets and equipment catalogues oe 17 | DQ. 19, OQ and - 18 Calibration Report of all sensors, controllers, transmitters, indicators ete, oe 19 Test certificates of all material of construction sets Constraints: 5.1 Material of construction: All contact parts: SS 316 with mirror finish All non contact parts: SS 304 with mat finish Gasket/seal/O ring: Food grade All welds should be ground finished Time lines: Response to URS & submission of quotation: Within 2 weeks Delivery: Within two month of order finalization Submission of detail design specification, electrical & mechanical drawing: within 3 weeks of order finalization. Submission of FAT/SAT specifications: three weeks before FAT 1Q & OQ protocol: With deliver