Installation Qualification (Iq) Protocol FOR Mechanical Sifter

Location Solid Manufacturing
INSTALLATION QUALIFICATION Reference No. IQ 007-18

IDAMAN PHARMA
PROTOCOL
MANUFACTURING Revision No. 00
FOR
SDN BHD Date 02 MAY 2018
MECHANICAL SIFTER
Page No. 1 of 22
INSTALLATION QUALIFICATION (IQ)

PROTOCOL
FOR
MECHANICAL SIFTER
IDAMAN PHARMA MANUFACTURING SDN BHD

Lot. 24 & 25, Jalan Perusahaan Lapan,
Bakar Arang Industrial Estate,
08000 Sungai Petani, Kedah Darul Aman.
IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 2 of 22
CONTENTS
1. REVIEW AND APPROVAL.......................................................................................................................... 3

2. PROTOCOL REVISION HISTORY.............................................................................................................. 4
3. OBJECTIVE................................................................................................................................................. 5
4. METHODOLOGY....................................................................................................................................... 5
5. METHODOLOGY....................................................................................................................................... 5
6. ASSOCIATED DOCUMENT & REFERENCE............................................................................................ 5
7. TERMS AND DEFINITIONS........................................................................................................................ 5
7. RESPONSIBILITY....................................................................................................................................... 6
8. EQUIPMENT AND PROCESS DESCRIPTION........................................................................................... 7
9. OVERVIEW OF IQ TESTS AND CHECKS.................................................................................................. 8
10. TESTS AND CHECKS................................................................................................................................ 9
10.1 DOCUMENT VERIFICATION...................................................................................................................... 9
10.2 INSTRUMENTATION IDENTIFICATION AND CALIBRATION VERIFICATION.....................................11
10.3 UTILITIES REQUIREMENT SPECIFICATION.........................................................................................14
10.4 CRITICAL COMPONENTS FEATURE VERIFICATION...........................................................................15
10.5 PRODUCT CONTACT PART MATERIALS REVIEW...............................................................................18
10.6 LUBRICANT VERIFICATION.................................................................................................................... 19
10.7 INSTALLATION, SAFETY AND PHYSICAL INSPECTION.....................................................................20
11. IDENTIFICATION OF PERSONNEL...................................................................................................... 21
12. LIST OF TEST INCIDENT REPORTS......................................................................................................... 22
13. LIST OF APPENDICES............................................................................................................................. 23
IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 3 of 22
1. REVIEW AND APPROVAL

1.1 PRE-APPROVAL
Installation Qualification (IQ) will be carried out in satisfactory manner and the results will be documented
correctly. This protocol has been reviewed and approved for execution by the following:
PRE-APPROVAL
PREPARED BY SIGNATURE DATE
Senior Executive of Technical Services
REVIEWED BY SIGNATURE DATE
Head of Technical Services
Head of Engineering
Head of Production
APPROVED BY SIGNATURE DATE
Head of Quality Assurance

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 4 of 22
1.2 POST APPROVAL

The tests and checks specified in this protocol have been carried out in a satisfactory manner and the
results documented correctly. All remaining Test Incident Report (If Any) listed have been considered and
will not affect the operation of Mechanical Sifter.
POST APPROVAL
PREPARED BY SIGNATURE DATE
Executive - Technical Services
REVIEWED BY SIGNATURE DATE
Head of Technical Services
Head of Engineering
Head of Production
APPROVED BY SIGNATURE DATE
Head of Quality Assurance

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 5 of 22
2. OBJECTIVE
The objective of this Installation Qualification Protocol is to document and qualify the Mechanical Sifter
installed at Idaman Pharma Manufacturing Sdn. Bhd.
3. METHODOLOGY
This Installation Qualification (IQ) protocol will document the result of installation of the Sieving machine.
The protocol and associated report will provide documented evidence for the installation of the Sieving
machine has been installed properly and meets the installation requirement.
4. SCOPE
This protocol will assess the following:
 Documentation
 Utilities Requirement
 Critical Components Feature
 Product Contact Part
 Installation, Safety and Physical Inspection
.
5. ASSOCIATED DOCUMENT & REFERENCE
1. PIC/S PE009-13, 01 January 2017.
2. ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities, Volume 5,
Commissioning and Qualification, First Edition, March 2001.
3. SOP, S-TCHS-006: Procedure to Perform Qualification for New Facility / System / Equipment
6. TERMS AND DEFINITIONS

The definitions of general terms used within the qualification study are given in Qualification Procedure.
Specific terms used within this protocol are defined below:
TERM DEFINITION
IQ Installation Qualification
PIC/S Pharmaceutical Inspection Co-operation Scheme
SOP Standard Operating Procedure
ISPE International Society for Pharmaceutical Engineering
GEP Good Engineering Practices

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 6 of 22
7. RESPONSIBILITY
The following table defines the responsibilities of personnel involved in compilation, execution and
approval of this IQ.
DEPARTMENT RESPONSIBILITIES
 Preparation of protocol
 Submission of completed protocol and report for approval prior to execution
Technical  Execution of Installation Qualification with Good Documentation Practices

Services  Compilation of test or data
 Initiate and submit Test Incident Reports for review
 Preparation of report
 Review and approve protocol
 Execute the Installation Qualification of the equipment with Good

Engineering
Engineering Practices (GEP)
 Review and approve report
 Review and approve protocol

Production  Assist Technical Services in the Installation Qualification execution
 Review and approve report
 Ensure that protocol has met its defined purpose

Quality
Assurance  Approval of protocol and report that met all technical, compliance and
quality requirements
IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 7 of 22
8. EQUIPMENT AND PROCESS DESCRIPTION
Mechanical Sifter is a circular unitary gyratory screen used to separate mass composition of solids from
solids, liquid from solid and for gradation of materials as per particle size, having a wide range
application. This is accomplished by vibrating the screens in three different planes along the vertical lines
by means of a specially designed vibratory motor having off centered weights at the top and bottom and
of the motor shaft.
The top weight causes vibration in the horizontal plane which causes the material to move across the
screen towards the periphery. The lower weight acts to tilt the machine which causes vibration in the
vertical tangential axis. The angle of lead of the lower weight with relation to the upper weight provides
variable control of the screening pattern. Thus, the material moves across the screens and also in the
vertical and tangential planes enabling maximum screening. This Mechanical Sifter is equipped with
mesh size 16, 20, 40 and 60.
IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 8 of 22
9. OVERVIEW OF IQ TESTS AND CHECKS

The following table defines all the testing within this IQ with its objective.
Section
Test Description Objective
Reference
To verify that all the lifecycle documentation of the

1. Document Verification Test
equipment is available and current.
To verify that the utilities requirement and

2. Utilities Requirement Verification specifications of equipment are available and within
the specification.
To verify that all the features of critical component of
3. Critical Components Feature Verification
the machine are installed ‘As Specified’.
To check product contact parts are made from as

4. Product Contact Parts Material Review
per manufacturer’s design.
To check the condition of the mesh that is being

5. Mesh Integrity Check
used with the machine.
Installation, Safety and Physical To inspect and verify the installation, safety and
6.
Inspection physical condition of the equipment.
SS Container
IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 9 of 22
10. TESTS AND CHECKS
10.1 DOCUMENT VERIFICATION
10.1.1 OBJECTIVE
To verify that all the lifecycle documentation of the equipment is available and current.
10.1.2 METHOD
Using the table of results, verify all the lifecycle documentation.
10.1.3 TEST TOOL
This is visual inspection only. No tools required.
10.1.4 ACCEPTANCE CRITERIA
All lifecycle documentations of the equipment are available and current
10.1.5 RESULTS
Acceptable Verified By
Description Document Reference Result
(Yes / No) (Initial and Date)
Operational Manual
Standard Operating
S-PNTT-015
Procedure:
Operation and Cleaning of
Operation and
Mechanical Sifter
Cleaning
Standard Operating
S-MNEG-064
Procedure:
Preventive Maintenance for
Preventive
Mechanical Sifter
Maintenance
User Requirement
User Requirement Specification for Sieving
Specification (URS) Machine
URS 002-18
Risk Assessment
(FMEA)
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 10 of 22
10.2 INSTRUMENTATION IDENTIFICATION AND CALIBRATION VERIFICATION
10.2.1 OBJECTIVE
To verify that critical instrumentation of on the machine have been identified and documented. All critical
instrumentation is calibrated.
10.2.2 METHOD
List the critical instrumentation in the table below; verify all critical instruments are calibrated.
10.2.3 TEST TOOL


All the critical instrumentation is listed its calibrations are valid. Records of calibration are correct and
available. Any instrument requiring calibration must be calibrated before commence.
10.2.5 RESULTS
Equipment Details As Specified Result
Heater
Control number
Model
Certificate No.
Compressed Air
Meter
Control number
Model
Certificate No.
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 11 of 22
Equipment Details As Specified Result
Temperature Gauge inside Mechanical Sifter Machine
Inlet temperature
Instrument
Control number
Model
Certificate No.
Outlet temperature
Instrument
Control Number
Brand
Certificate No.
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 12 of 22
Description As Specified Result
Control System FRL meter
Control No
Cert No.
Atomizing Droplet Control
Control No
Certificate No
Pattern Air Control
Control No
Certificate No
Opening Control
Control No
Certificate No
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 13 of 22
10.3 UTILITIES REQUIREMENT SPECIFICATION
10.3.1 OBJECTIVE
To verify that utilities requirement and specifications of equipment are available.
10.3.2 METHOD
Using the table of results, verify all the listed utilities against ‘As Specified’.
10.3.3 TEST TOOL
All supporting utilities are available ‘As Specified’.
10.3.5 RESULTS
Electricity
Phase
Ampere
Voltage
Frequency
Compressed Air
Compressed air required

by machine
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 14 of 22
10.4 CRITICAL COMPONENTS FEATURE VERIFICATION
10.4.1 OBJECTIVE
To verify that all the feature of critical component of the Mechanical Sifter are installed per ‘As
Specified’.
10.4.2 METHOD
Using the following table, inspect and verify all the components features. Record all observation in the
following table.
10.4.3 TEST TOOL
Tape Measurer and visual inspection only.
All critical installed components are installed correctly as per operation manual.
10.4.5 RESULTS
Coating Unit
Cabinet
Manufacturer
Coating Pan
Pan Size
Diameter
Pan Mouth
Diameter
Capacity
Drainage
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 15 of 22
Driving Unit
Motor
Speed controller
Hot Air Unit
Dimension
Electrical Heater
Fan’s Motor
Exhaust Air Unit
Dimension
Fan’s Motor
Peristaltic Pump
Brand
Voltage
Serial No.
Stirrer Motor
Brand
Model
Serial No.
Power
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 16 of 22
Stirrer Motor Gearbox
Brand
Serial No.
Type
Control System
Schlick Spray Gun
Main FRL with Meter
Atomizing Droplet Control
Model
Brand
Tubing
Pattern Air Control
Model
Brand
Tubing
Opening Control
Model
Brand
Tubing
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 17 of 22
10.5 PRODUCT CONTACT PART MATERIALS REVIEW
10.5.1 OBJECTIVE
To check product contact parts are made from stainless steel or pharmaceutical grade materials.
10.5.2 METHOD
a. By visual, verify the following product contact parts have been installed against the tank.
b. The product contact parts test by using Molybdenum Test Kit (Avesta - 960).
c. Drop of chemical at Stainless Steel change colour to dark brown (moly present).
10.5.3 TEST TOOL
Molybdenum Test (Avesta - 960)
316L Stainless Steel change colour from white to dark brown (moly present)
10.5.5 RESULTS
Coating Pan
Spray Gun
Peristaltic Pump’s
Tubing
Stirring Rod
Stirrer
Coating Solution
Tank
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 18 of 22
10.6 LUBRICANT VERIFICATION
10.6.1 OBJECTIVE
To verify that the suitable type of lubricant to be used thus prolong the equipment shelf life.
10.6.2 METHOD
Using the table of results, verify all the listed attribute against “as specified”.
.
10.6.3 TEST TOOL
To verify that the lubricants supplied are as per manufacturer recommendation.
10.6.5 RESULTS
Location Where Type of Verified By

Application Part Grade Supplier
Used Lubricant (Initial and Date)
Industrial
Gearbox (Stirrer) Gear HD 40 Mobil
Grade
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 19 of 22
10.7 INSTALLATION, SAFETY AND PHYSICAL INSPECTION
10.7.1 OBJECTIVE
To inspect and verify the installation, safety and physical condition of the equipment.
10.7.2 METHOD
Using the table of results, verify all the listed attribute against ‘As Specified’.
10.7.3 TEST TOOL
All the installation, safety and physical inspection must be inspected and found satisfactory.
10.7.5 RESULTS
Inspection Verified By
Description As Specified
Satisfactory (Initial and Date)
Equipment supplied As purchase order or equivalent Yes / No/ NA
All replacement part identified and

Spare parts Yes / No/ NA
listed
Emergency stop/alarm/interlock
Safety Inspection Yes / No/ NA
installed/ safety door
No damage and installation to good

Physical Inspection Yes / No/ NA
workmanship standard
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 20 of 22
11. IDENTIFICATION OF PERSONNEL

The following is a record of each individual who is involved in the execution of this protocol.
Signatures
Company /
Title Name Date
Department
Full Initials
IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 21 of 22
12. LIST OF TEST INCIDENT REPORTS
The following table details all Test Incident Reports / non-conformances identified during the execution
of the IQ. All Test Incident Reports / non-conformances identified require the initiation of a Test Incident
Report Form.
Test Corrective
Ref.
Incident Test Incident Report Action Date
Protocol Corrective Action
Report Details Implemented Resolved
Section
No. By:
COMMENTS:
Reviewed By: Date:

IDAMAN PHARMA
PROTOCOL
FOR
MECHANICAL SIFTER
Page No. 22 of 22
13. LIST OF APPENDICES
Appendix Protocol Test No. of

Appendix Title
No. Section (s) Pages
14. REVISION HISTORY
Rev. No. Date Issued By Remarks
00 02 MAY 2018 M. IYAD AL-MALIKI Original Release

Installation Qualification (Iq) Protocol FOR Mechanical Sifter

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Location Solid Manufacturing

INSTALLATION QUALIFICATION Reference No. IQ 007-18

INSTALLATION QUALIFICATION (IQ)

IDAMAN PHARMA MANUFACTURING SDN BHD

1. REVIEW AND APPROVAL.......................................................................................................................... 3

1. REVIEW AND APPROVAL

Senior Executive of Technical Services

REVIEWED BY SIGNATURE DATE

Head of Technical Services

APPROVED BY SIGNATURE DATE

Head of Quality Assurance

1.2 POST APPROVAL

Executive - Technical Services

REVIEWED BY SIGNATURE DATE

Head of Technical Services

APPROVED BY SIGNATURE DATE

Head of Quality Assurance

6. TERMS AND DEFINITIONS

PIC/S Pharmaceutical Inspection Co-operation Scheme

SOP Standard Operating Procedure

ISPE International Society for Pharmaceutical Engineering

GEP Good Engineering Practices

 Submission of completed protocol and report for approval prior to execution

Technical  Execution of Installation Qualification with Good Documentation Practices

 Initiate and submit Test Incident Reports for review

 Review and approve protocol

 Execute the Installation Qualification of the equipment with Good

 Review and approve protocol

 Review and approve report

 Ensure that protocol has met its defined purpose

8. EQUIPMENT AND PROCESS DESCRIPTION

9. OVERVIEW OF IQ TESTS AND CHECKS

To verify that all the lifecycle documentation of the

To verify that the utilities requirement and

To check product contact parts are made from as

To check the condition of the mesh that is being

10. TESTS AND CHECKS

10.1 DOCUMENT VERIFICATION

Using the table of results, verify all the lifecycle documentation.

10.1.3 TEST TOOL

This is visual inspection only. No tools required.

10.1.4 ACCEPTANCE CRITERIA

All lifecycle documentations of the equipment are available and current

Reviewed By: Date:

10.2 INSTRUMENTATION IDENTIFICATION AND CALIBRATION VERIFICATION

10.2.3 TEST TOOL

10.2.4 ACCEPTANCE CRITERIA

Reviewed By: Date:

Temperature Gauge inside Mechanical Sifter Machine

Reviewed By: Date:

Atomizing Droplet Control

Pattern Air Control

Reviewed By: Date:

10.3 UTILITIES REQUIREMENT SPECIFICATION

To verify that utilities requirement and specifications of equipment are available.

10.3.3 TEST TOOL

This is visual inspection only. No tools required.

10.3.4 ACCEPTANCE CRITERIA

All supporting utilities are available ‘As Specified’.

Compressed air required

Reviewed By: Date:

10.4 CRITICAL COMPONENTS FEATURE VERIFICATION

10.4.3 TEST TOOL