PHARMA DEVILS

PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No.....
FUNCTIONAL AREA: PRODUCTION Page No.: 1 of 12

USER REQUIREMENT SPECIFICATION

NAME OF THE ITEM: POWDER INJECTION FILLING & PLUGING MACHINE

FUNCTIONAL AREA: STERILE FILLING AREA

PROTOCOL No. :
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 2 of 12
CONTENT

S.No. Description

1.0 URS Approval

2.0 Objective
3.0 Responsibilities
4.0 Equipment Description & Identification
5.0 User Requirements
6.0 Complementary aspects
7.0 Safety and environmental Protection
8.0 Cleaning maintenance and service
9.0 Rules and Regulation
10.0 Scope of Delivery
11.0 Installation ,Commissioning and Tests
12.0 Qualification/Validation
13.0 Guarantee/Warrantee
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 3 of 12
1.0 URS APPROVAL:

Protocol Prepared By:

Functional area Name Signature Date

Production

URS Reviewed By:

Functional area Name Signature Date

Production

Quality Assurance

Engineering

URS Approved By:

Functional area Name Signature Date

Head Engineering

Head Manufacturing

Head Quality
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 4 of 12
2.0 Objective:
The purpose of this document is to ensure that all the critical aspects of the Equipment, cGMP &
Safety features have been considered in designing the equipment/instrument and is properly
documented.

3.0 Responsibilities:
In accordance with the document, following functions shall be responsible for initiation and
finalization of Equipment user requirement specification. When the work is carried by contract/
consulting staff, all the work is to be performed under the oversight of ………………...

3.1 Preparation of Document

 User department to prepare the URS
 Ensures that the document is in compliance with current policies and procedures of cGMP
regulations.
 Ensures that the content is sufficient, clearly defined, technically sound and accurate.
 It is a Guidance document to prepare the URS.

3.2 Review of Document

 To be reviewed by Head of the user department and functional department (Engineering & Quality
assurance)

3.3 Approval of Document

 Approval of document by Head Manufacturing/Head Engineering/Head Quality.

4.0 Equipment Description & Identification:

4.1 Scope:
This document covers all aspects of Users requirements for the Equipment/Instrument along with all
Attachment, Spare Parts, Change Parts and Accessories to be used in …………….

Scope incorporates understanding and documentation of critical requirements such as system

requirements, cGMP requirements, safety requirements, documentation requirements and
operational requirements.

4.2 Purpose:
For the filling of Dry powder injection in sterile filling area.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 5 of 12
5.0 USER REQUIREMENTS

5.1 System Requirements:

S.No. SYSTEM COMPONENTS SYSTEM REQUIREMENTS

1. Identification Details of Make, Name, Serial. No., Capacity, Model and
(In case of
Year of manufacture should be available
Equipment /Instrument)
2. Model/Type High speed injection powder filling with rubber stoppering
machine. Confirming to current CGMP requirements.
3. Capacity 7.5 ml to 30 ml molded & tubular vials with Minimum speed
300 vials/ minute
4. Potential Suppliers 1.Ambica
2.N.K.P pharma
5. Contact parts (In case of SS316L with mirror finish
Equipment)
6. Non contact parts (In case of SS304 with mirror finish
Equipment)
7. Non metallic contact parts 1. Any material with food grade quality having no
(In case of Equipment /Instrument)
Potential impact on the products.
2. Durable.
3. Must be easily cleanable.
8. Motor & Electrical installations (In Machine should be operated through PLC mounted on
case of Equipment /Instrument)
separate electrical control panel.
9. Machine assemblies (In case of Must be covered with SS 304 with mirror finish.
Equipment /Instrument)
10. Machine adjustments (In case of Setting with Zero clearance with good accuracy.
Equipment /Instrument)
11. Packaging & Transport Should be packed and transported in such a way to avoid any
damage during transportation.
12. No. of requirements 01

13. Requirements for any power failure To be backed up by installed in-house DG set. After any
backup’s (In case of Equipment
power failure PLC show continuous counting of all filled &
/Instrument)
sealed vials.
14. Gear box specifications(In case of As per cGMP model
Equipment /Instrument)
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 6 of 12
5.2 Technical Description

S.No. SPECIFICATION SYSTEM REQUIREMENTS

1. Machine should be operated through PLC. YES

2. 21 CFR part 11 compliant software YES

3. Machine should be provided vial inspection table YES

with vial counter.
4. Double track for filling operation YES

5. Double 12 port powder wheel & double primary & YES

secondary hopper.
6. Port cleaning system (purging unit) YES
7. Multiple dosing system ( up to maximum 4 dose in YES
one track)
8. Media filling system (with 2 nos. of standard S.S YES
syringes -10 ml, 30 ml)
9. Pre & post gassing system YES
10. Machine should be provided vial inspection table YES
with vial counter.
11. Double track for filling operation YES

6.0 COMPLEMENTARY ASPECTS

6.1 Training

S.No. Specification SYSTEM REQUIREMENTS

6.1.1 The vendor Shall supply all available information for the YES
adequate exploitation of equipment. For the Compliance
of this purpose at the Job site and/ or at the Vendors Shop.
Vendor’s technical staff shall train customer’s personnel.
The scope of the
Training will be agreed during the contract signature.

6.1.2 The supplier is to include the personnel training activities. YES

The contractor is to specify the foreseen time for:
 Operator/Supervisor training
 Manager Training
 Electrical maintenance training
 Mechanical Maintenance training
6.1.3 The contractor is to specify the personnel background YES
needed for each of the operators maintenance.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 7 of 12

6.2 Pre Delivery Qualifications (FAT)

S.No. Specification SYSTEM REQUIREMENTS

6.2.1 The System or its parts as provided for in the scope YES
of supply shall be pre-installed at the vendors shop
prior to delivery to customer site. Installation will
be completed and documented including
mechanical parts as well as electrical connections
of all parts to facilitate taking over tests at Vendors
shop prior to delivery.

6.3 Supplier Technical Documentation Requirements:

S.No. COMPONENTS REQUIREMENTS

6.3.1 Drawings Pre Installation Requirements will be supplied by
 Equipment/Systems electrical drawing.
Vendor
 Point to point wiring diagram
6.3.2 LIST.
 Equipment and instrument list with
YES
Component description.
 Electrical component parts list with
Description. YES
 Function check list.

 Documentation list. YES

 Spare part list YES

List of spares required for smooth operation will be
provided by the Vendor at the time of ordering.

6.4 Technical Manuals

S.No. Specification Requirements

6.4.1 Operating handbook YES
6.4.2 Trouble Shooting Guide YES
6.4.3 Equipment Description YES
6.4.4 Equipment specification YES
6.4.5 Calibration Instruction YES
6.4.6 Maintenance Instruction YES
6.4.7 Maintenance Handbook YES
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 8 of 12

7.0 SAFETY AND ENVIRONMENTAL PROTECTION

S.No. Specification Requirements

7.1 Alarm for without filled vials YES
7.2 All motors have to be thermally Protected. YES
7.5 All the Installation must be in accordance with the cGMP. YES
7.6 The cGMP concerning safety must be applied. YES
7.7 Safety interlock- YES
 Emergency stop button should be provided in the control panel.
 No vial – No filling conveyor stop.
 No powder – filling stop.
 Fill weight low / high from set value – Filling stop.
 Nitrogen pressure low from set value – Filling stop
 Vacuum low from set value – Filling stop
 Sleeping vial coming – machine stop

8.0 CLEANING MAINTENANCE AND SERVICE

S.No. Specification

8.1 In accordance with cGMP guidelines the units must be easy to clean, to disinfect, and where necessary,
to sterilize.
8.2 The Supplier should guarantee that, if required, a service team can be on site within one working day.
8.3 The design should be such as to allow mechanical cleaning of the surface and that the cleanliness of the
surface can be checked easily.
8.4 All machine parts, in particular instrumentation, should be constructed so that they can be easily
removed and calibrated.
8.5 All special tools required for running and maintenance should be best.
8.6 A spare parts delivery guarantee with in time.

9.0 RULES AND REGULATION

These standards, recommendation and requirements are considered the minimum. Specifications that are
more stringent or expansive take the precedence. In case of conflict between published requirements, final
determination is the responsibility of the Owners Representative.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 9 of 12

10. SCOPE OF DELIVERY

S.No. Specification Requirements

10.1 Units described in the specific system requirements including all YES
necessary controls and instrumentation.
10.2 The complete mechanical and electrical installation. YES

10.3 The Connections to all the necessary utilities, exhaust, and waste lines Yes
necessary for its operation.
10.4 All piping and cabling of the units itself. YES

10.5 Wiring and cable run…………. will supply the main power switches to be YES
located in correspondence to the electrical and control cabinets delivered
by the equipment supplier.
10.6 All internal contacts of the supplied equipment for the required utilities. YES

10.7 Unload on site of the equipment: the supplier is required to define all the YES
necessary handling devices required to the unloading operation.
The supplier will inform at least 4 weeks in advance the day of delivery
and the list of required handling devices.
10.8 Assembling operation: the required consumable, the internal YES
transportation, the assembling tools and the required personal are part of
the supply.
10.9 A complete set of commissioning spare parts. YES
10.10 All special tools necessary for use and maintenance of the supplied YES
equipment.
10.11 A complete set of two years spare parts should be listed quoted and YES
offered as option.
10.12 All test activities as specified in this document. YES
10.13 Training in the use and maintenance of the equipment. YES
10.14 A complete set of documentation as specified in this document. YES
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 10 of 12

11.0 INSTALLATION, COMMISSIONING AND TESTS

11.1 General

S.No. Specification Requirements

11.1.1 The Contractor must specify for each piece of equipment the Guaranteed YES
performance and the guaranteed system performance. These values will be
tested during the acceptance tests.
11.1.2 In addition the functionality described in the user requirements and detailed in YES
the system specifications will be tested.

11.2 INSTALLATION, COMMISSION

S.No. Specification Requirements

11.2.1 The commissioning tests will be carried out in accordance with a written test YES
plan developed by the supplier with clearly stated test procedures and
acceptance criteria.
11.2.2 The contractor will approve successfully completed tests and will specify YES
items requiring additional work. Representatives from ……….will attend and
participate in the commissioning tests as required.
11.2.3 The installation and commissioning of the system will be performed at the YES
…………facility by the contractor.
11.2.4 The commissioning can only start once all the foreseen documents have been YES
delivered by the supplier to ……………….
11.2.5 All equipment should be properly installed, adjusted, leveled, tagged, and YES
connected with utilities.
11.2.6 Point to point checks on wiring and pneumatic should be performed. YES

11.2.7 All instruments should be properly calibrated. YES

11.2.8 A equipment (instrument) used for qualification must be listed and approved YES
by ……………..
11.2.9 The calibration equipment must have all the necessary documents to YES
demonstrate their maintenance & use.
11.2.10 The last calibration of all this equipment must be less than 6 months old, and YES
evidenced by certificate.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 11 of 12
S.No. Specification Requirements

11.2.11 Verification that the interior surfaces of equipment are free of practices and YES
dirt and all points of product contact meet the specified material requirements.
11.2.12 All the clearances and tolerances specified in the drawing or recommended YES
by component manufacturers are correct.
11.2.13 On site verification that valves and other equipment with moving parts are in YES
their normal position if in a power down condition and move in the correct
direction with the correct speed and precision.
11.2.14 Verification that all the Input and Output points are connected and labeled YES
according to the documentation and that all the along the input values have
been scaled in accordance with the system specification and process
requirements. That all equipment components requiring configuration
11.2.15 The commissioning should demonstrate that the system supplied by the YES
contractor has been properly installed and that the functions are in accordance
with …………... User Requirements specifications, Vendors System
specifications Manuals and other Documentation.

11.3 Site Acceptance Test (SAT)

S.No. Specification Requirements

11.3.1 This test will be carried out once the commissioning will be completed. The YES
scope will be to verify the performance and the functionality of the system
integrated with the other factory systems (Including sterility testing of at least
02 days).
11.3.2 The test will be carried out to verify the system response with the expected YES
productivity of the system.
11.3.3 Details on the test realization will be defined during the project Phase. The YES
supplier is asked to specify the proposed duration for SAT and the standard
procedure proposed.
11.3.4 During SAT the required functionality, performances and system reliability YES
are met.
11.3.5 The Functionality described in the User Requirements Specification and in the YES
System Specifications are verified and met.
11.3.6 All the documentation agreed has been delivered. YES
 PHARMA DEVILS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: POWDER INJECTION FILLING & PLUGING MACHINE PROTOCOL No....
FUNCTIONAL AREA: PRODUCTION Page No.: 12 of 12
12.0 QUALIFICATION/VALIDATION

S.No. Specification Requirements

12.1 The maintenance Qualification is responsibility of the customer. However, YES
the supplier is responsible for delivering the basic documents for maintenance
qualification.
12.2 This includes all side costs such as: calibration measuring equipment and YES
instruments: manpower (IQ and OQ will take place completely on ……….)
12.3 Time Schedule for IQ/OQ execution will be developed by …... With the YES
supplier.
12.4 Suppliers personnel used for IQ/OQ must be well trained and experienced. YES
This should be documented.
12.5 The onsite test run performed by the supplier might become part of the IQ. YES
12.6 Main IQ/OQ steps such as calibration must be performed and documented in YES
accordance to a SOP approved by ………
12.7 All equipment used for qualification must be listed and approved by ………. YES
The calibration equipment should be well documented.
12.8 The last Recalibration of all this equipment should be less than 06 month old. YES
Proofed by Certificate.
12.9 OQ can only start after IQ approved by ………. YES
12.10 IQ will be carried out by ………. During Installation phase. IQ will include YES
the tests performed by the contractor.
12.11 Part of the OQ will be carried out by ……... During commissioning and SAT YES
phase. OQ will include the tests performed by the contractor.
12.12 After installation of the equipment at customers site. Complementary IQ & YES
OQ tests will be performed by the Customer and may be supervised by a
member of Technical staff.
12.13 Qualification documents (In case of equipments/Instruments) DQ, IQ, OQ & PQ

13.0 GAURANTEE/WARRANTEE

S.No. Specification Requirements

13.1 The System must be guaranteed including all the sub- system and YES
components for a period of 12 months from the date of the system acceptance
for a 03- shift operation.
13.2 The servicing companies involved for the Sub- systems maintenance must be YES
declared and the maintenance group organization described. Furthermore, the
contractor will be directly responsible of the system assistance and the
required operation will be co- ordinate by him.
13.3 In case of failures, the intervention will be guaranteed by the contractor YES
within a maximum time limit. The contractor is asked to specify the
maximum time limit.
13.4 The supplier is asked to propose as option maintenance and assistance YES
contract after the guarantee expiration.