MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

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VIBRO SIFTER
30” DIA. (GMP MODEL)
INSTALLATION QUALIFICATION

CLIENT

P.O. NO.
LOCATION
OUR REF. NO.
MODEL NO.
JOB NO. /S.R.NO.

Please read and understand the installation, operation and maintenance manual carefully. In case of
any doubt please feel free to write us.
Contents are subject to revision without any notice.
Caution
Failure to comply with the instructions in this manual may result in damage to equipment and
personnel.

Office & Factory Address:

Allied
MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT
Unit No. 17, Param Industrial Estate, Naik Pada,
Waliv, Vasai (East), District Thane- 401 208,
Maharashtra, India. Fax: 0250 –: 2451675
Tel : 6451697, 6454301, 2451674
Email: [email protected]
 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

INSTALLATION QUALIFICATION PROTOCOL

Name of the Equipment : VIBRO SIFTER 30” Dia.

Name of the client :

Name of Manufacturer : ALLIED.

Unit No. 17, Param Industrial Estate,
Naik Pada, Waliv, Vasai (E).
District Thane- 401 208, Maharashtra, India.

PROTOCOL APPROVAL COVER

Name Department Sign / Date

Initiated by: Documentation

Reviewed by: (Quality Assurance Dept.)

Approved by: (Project Dept.)

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CONTENTS

SR. NO. TITLE

1 Unpacking & Checking
2 Introduction & Working principles
3 Instruction before Operating the machine
4 Angles can be adjusted by following method
5.0 Introduction (Operating Procedure)
5.1 Objective
5.2 Background
5.3 Scope
5.4 Acceptance Criteria
5.5 Exceptional Conditions and Deviations
5.6 Validation Approach
6.0 Evaluations
6.1 General
6.2 Equipment and System Utilities
6.3 Maintenance Program
6.4 Lubricants
6.5 Engineering Drawings
6.6 Controls, Alarms and Interlocks
6.7 SOP Identification
7.0 Revalidation Criteria
8.0 Deficiency and Corrective Action Report
9.0 Attachments

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1. UNPACKING AND CHECKING

a) Unpack the cases and the crates carefully under the supervision of a
responsible person and remove the contents without trying to force open any
package.

b) Check the contents with the packing list.

c) Should any shortage be observed in the first check, the case, individual
packages, also the packing materials should be thoroughly searched for a
second time in the presence of person who will certify the shortage report.
Similarly, for any wrong supply of parts and components, the matter should be
immediately brought to the notice M/s. Bombay Pharma Equipments Pvt.
Ltd. giving full reference of supply.

d) In case of breakage or damage, the nature and extent of each article,

component or equipment should be documented in clear and precise terms and
the report sent to the supplier within a week of the receipt of the supply.

e) All the parts and components should be thoroughly cleared of packing

materials before assembly with particular reference to moving parts.

f) All contact parts should be washed thoroughly with warm water and soap
before the equipment is put in production.

2. INTRODUCTION & WORKING PRINCIPLES

a) Vibro Sifter is a self-contained unit ideally suited for sieving dry, wet
powders, Granules etc. We are manufactured in 12”, 20” Dia., 30” Dia., 36”
Dia. & 48” Dia. in single as well as multiple deck arrangements.

b) It uses principle of powder trumbling and interacting because of specially

designed vibrating motor with adjustable petals directly mounted on a top
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plate, which is rested on spring pad to achieve continuous vibrations. The

vibrating energy screen unit consisting of circular pretightened screen causes
vibration in the vertical tangential axis and top petals causes vibration in the
horizontal plain to move the material across the screen towards the discharge
spot.

c) The time required for screening the powder of each batch is to be established
by trial depend on the mesh used, but keeping upper limit of 250 Kgs. /hr. 2, 3
Decks may be provided for differential screening of powder.

All products contact parts of machine are made of stainless steel 316 quality &
non-contact parts depending upon requirement.

3. INSTRUCTION BEFORE OPERATING OF MACHINE

The machine is made out of self-contained cylindrical ring frame.

a) Ensure that the frame is perfectly level.

b) Connect 3 Phase AC, 415 V, 50 cycle electric supply through a suitable

isolator & starter.

c) Tighten all nuts and bolts (there is possibility of their getting loosened during
transportation)

d) Ensure effective earthling to the equipment.

e) Electrical:
i) All the electrical connections should be tightened and properly
connected.
ii) Motor connections should be maintained to give clockwise rotation.

f) Charge the material in to the screen for screening.

g) Run the machine for desired screening time to be established on trial.

CAUTION:

Insulate all electrical switches before cleaning / removing the screen.

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5.0 INTRODUCTION (OPERATING PROCEDURES)

5.1 OBJECTIVE

• The objective of this is to provide guidelines for the installation

of the installation of Vibro sifter.
• To ensure that the equipment and system are installed in the
granulation area and meet the specification as set out in the design
qualification document.
• To ensure that the various SOPs related to the system have been
identified and listed.
• To ensure that all the critical instruments have been identified
and documented for calibration.

5.2 BACKGROUND

Vibratory sifter is a self contained unit suited for sifting of raw

materials or dry granules. The design of the equipment includes feature
to assure GMP operations and easy cleaning. Safety during operation
has also been considered.

Equipment Name Vibro Sifter

All Products contact parts are of S.S. 316 quality material and non-
contact parts are of S.S.304 or cladded with S.S.304 quality material.

5.3 SCOPE

This report will define the procedures, documentation, acceptance

criteria and revalidation criteria to establish that the equipment has been
installed as required in the processing environment.

5.4 ACCEPTANCE CRITERIA

The successful execution of this report in accordance with the desired
requirement as mentioned in the specification of the equipment will
verify that the Vibro sifter has been installed as per GMP requirements
and is ready for operation.

5.5 EXCEPTIONAL CONDITIONS AND DEVIATIONS

Any minor changes of deviations that are necessary to comply with this
report will be documented in the final report.
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5.6 VALIDATION APPROACH

Responsibility: Vendors (BOMBAY PHARMA) IQ Validation team
Ensure that:

1. Purchase order copy is available.

2. Factory Acceptance Test (FAT) document is approved and is in
place.
3. Personnel responsible for installation have undergone proper training
to install the equipment.
4. Required utilities are installed in right capacities.
5. Following drawing are in place.
a) General Arrangement Drawing
b) Electrical circuit diagram
c) Location layout drawing
6. All documents like equipment manual, list of spare parts, list of
lubricants etc. are available.
7. Certificates of M.O.C. are in place.
8. Cleaning procedures are developed and approved.
9. All materials and tooling are available for installation of the
equipment.
The equipment was installed as per the installation procedure provided
in the equipment was cleaned, tagged with equipment number and was
included in the preventive maintenance schedule.
Installation documents were reviewed by validation team and a report
was generated for approval.

7.0 EVALUATIONS

7.1 General
Complete data sheets in Attachments 1 and 2 including:
• Equipment and System Description
• Manufacturer’s Specifications
• Purchase Orders
• Materials in Product Contact

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7.2 Equipment and System Utilities

Complete data sheets in Attachment 3 including:
• Following utilities shall be required for installation of the
equipment.
Electrical

7.3 Maintenance Program

Complete data sheets in Attachment 4 including:
• Equipment Maintenance Program

7.4 Lubricants
Complete data sheets in Attachment 5 including:
• Non In Product/Critical Component Surface Contact

7.5 Engineering Drawings

7.5.1 Complete data sheets in Attachment 6 including:
• Engineering Drawings

7.6 Controls,
7.6.1 Complete data sheets in Attachment 7 including:
• Controls

7.7 SOP Identification

Complete data sheets in Attachment 8 including:
• Initial Cleaning

8.0 REVALIDATION CRITERIA

The equipment shall be subjected to installation, requalification only under

following reasons:

8.1 Change in location of equipment

8.2 Change in the source of any of the utilities being supplied to the
equipment

8.3 Shifting of the equipment for major maintenance or modification and

again location at the same place after completion of work

9 DEFICIENCY AND CORRECTIVE ACTION REPORT

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.
ATTACHMENTS

IQ Data Sheets
ATTACHMENT 1
IQ Data Sheets - General

EQUIPMENT AND SYSTEM DESCRIPTION

Identify and document all equipment associated with the system undergoing IQ. Add
additional pages if necessary.

TECHNICAL SPECIFICATION

Model No. /
Sr. No. Name of Components Make
Part No.
1 Main Motor (0.5 HP)
2 Gasket

Contd….

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ATTACHMENT 1
IQ Data Sheets - General

LIST OF SPARE PARTS

List all the spare parts with their manufacturer.

DESCRIPTION MANUFACTURER
Dust over Bombay Pharma Equipments Pvt. Ltd.
Top deck Bombay Pharma Equipments Pvt. Ltd.
Bottom Deck Bombay Pharma Equipments Pvt. Ltd.
Sieves with Mesh Frame Bombay Pharma Equipments Pvt. Ltd.
‘C’ Clamps Bombay Pharma Equipments Pvt. Ltd.
Bottom deck Bombay Pharma Equipments Pvt. Ltd.
Spring Bombay Pharma Equipments Pvt. Ltd.
Spring locating bush Bombay Pharma Equipments Pvt. Ltd.
PU Coating Wheel with Break Bombay Pharma Equipments Pvt. Ltd.

PURCHASE ORDERS

Identify all purchase orders associated with the system.

Vendor Name PO # Description

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CHECKS FOR INSTALLATION QUALIFICATION

Sr. Acceptance Checked

Parameters Observations Date
No. Criteria by
Horizontal
1 leveling of the Perfectly Horizontal
equipment
Aligned vertically
straight with
Positioning of
2 sufficient space for
the equipment
maintenance

Floor
3 No vibrations
balancing

Identification
4 Manufacturer’s Name
Plate

5 Surface Finish Smooth & matt

Any physical
damage to the No scratches or
6 equipment / damage should be
floor or room observed
walls

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OBSERVATIONS FOR ALL ELECTRICAL CONNECTIONS PROVIDED TO THE EQUIPMENT

Sr. Checked
Parameters Acceptance Criteria Observation Date
No. by
A. No loose hanging cables
General B. Well-insulated electrical wiring.
method of the C. Located in a safe place well
1 electrical protected from water seepage
wiring during machine or floor
cleaning and also safe for
operator during operation
A. Electrical drawing available
Electrical
either pasted in the inside of
2 drawing
the circuit box or as in the
manual.
Switches for
electrical There should be one machine
3 operation of switch for operating and one
the equipment separate power main switch.

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ATTACHMENT 2
IQ Data Sheets
PRODUCT CONTACT PARTS
List all materials in the equipment that come in product contact:

MOC
Checked
Part Material Certificate Date
by
Available?
Dust Cover SS 316 Yes / No
Top Deck SS 316 Yes / No
Mesh Frame SS 316 Yes / No
‘C’ clamps SS 316 Yes / No
Bottom deck SS 316 Yes / No

PRODUCT NON- CONTACT PARTS

List all materials in the equipment that do not come in product contact:

Part Material Checked by Date

Spring S.S.
Eccentric top weight M.S.
Gasket Silicon
Auxiliary top weight M.S.
Base plate S.S.304 Quality

Note: Please ensure that all the certificates are available and traceable to national
standards.

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ATTACHMENT 3
IQ Data Sheets

UTILITIES
Identify and document the installation’s utility requirements.

Actual
Service Requirements Checked By
Supply
Electrical
Voltage 415 V + 10% , - 10%
Phase 3
Amperage 0.8 (no load)
Frequency 50 Hz + 5 % - 5 %
Supply wiring 2.5 sq.mm. 4.0 core
Earthing Available

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ATTACHMENT 4
IQ Data Sheets

EQUIPMENT MAINTENANCE PROGRAM

Sr. Parameters to be
Name of Component Frequency
No. checked
1 Dust cover Cleanliness Daily
2 Top Lid Cleanliness Daily
3 Discharge Deck Cleanliness Daily
4 Sieves / Mesh Cleanliness Daily
5 Gasket Cleanliness Daily
6 “C” clamp Cleanliness Daily
7 Shell Cleanliness Daily
8 PU Coated wheel with break Check/tighten Monthly
9 Bolt of base and motor Cleanliness & tighten Monthly
10 Grease motor bearing Lubrication Monthly
11 Motor terminal Check/tighten Monthly

ATTACHMENT 5
IQ Data Sheets

LUBRICANTS NOT IN PRODUCT/CRITICAL COMPONENT SURFACE

CONTACT

List lubricants that do not come in product contact.

Name Description Used For

Grease Sentinel Grease Motor bearing

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ATTACHMENT 6
IQ Data Sheets

ENGINEERING DRAWINGS

Identify engineering drawings that are associated with the equipment being validated

Drawing # and Storage Location Title

Manager, Formulation Development Location Drawing

Manager, Formulation Development Equipment Drawing

Manager, Formulation Development Electrical Drawing

ATTACHMENT 7
IQ Data Sheets

CONTROLS, ALARMS AND INTERLOCKS

Identify controls that are associated with the item being validated. Enter the name of
the control, alarm or interlock in “Name”, describe what it does in “Function
Description”

Name
Function Description Identified By / Date

Electrical Insulation Avoid accidental hazard

Earthing To avoid the shock

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ATTACHMENT 8
IQ Data Sheets

SOP IDENTIFICATION

Sr. Title of SOP SOP Checked

Particulars
No. Available? by

Set up and Operation of the

1 Operation Machine Yes / No

Cleaning of the Machine

(Passivation Cleaning
2 Cleaning
Procedure For Equipment) Yes / No

Preventive Maintenance of
Preventive
3 the Machine Yes / No
Maintenance

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