PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

INSTALLATION QUALIFICATION

PROTOCOL CUM REPORT

FOR

PASTE KETTLE

(CAPACITY- 200 LITRES)

EQUIPMENT ID. No.

LOCATION Solution Preparation Room ,

Coating Area
DATE OF QUALIFICATION

SUPERSEDES PROTOCOL No. NIL

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

CONTENTS

S.No. TITLE PAGE No.

1.0 Pre-Approval 3

2.0 Objective 4

3.0 Scope 4

4.0 Responsibility 5

5.0 Equipment Details 6

6.0 System Description 6

7.0 Pre-Qualification Requirements 8

8.0 Critical Variables to be Met 9

9.0 References 17

10.0 Documents to be Attached 17

11.0 Deviation from Pre-Defined Specification, If Any 18

12.0 Change Control, If Any 18

13.0 Review (Inclusive of follow up action, If Any) 18

14.0 Conclusion 19

15.0 Recommendation 19

16.0 Abbreviations 20

17.0 Protocol Post Approval 21

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

1.0 PRE – APPROVAL:
INITIATED BY:

DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

2.0 OBJECTIVE:
 To provide documented evidence for the Installation Qualification of Paste Kettle for ……
 To confirm that the equipment and its components are installed as per the Specifications mentioned
in the design qualification document and other requirements given by supplier.

3.0 SCOPE:
 The scope of this installation qualification protocol cum report is limited to qualification of Paste
Kettle (Make- Bectochem, Capacity- 200 liter) to be installed in Solution Preparation Room of
Coating Area.
 Said Equipment was in Granulation, earlier now .it has been shifted in Coating Solution Preparation
area, Refer more details by respective change control.
 This document provides all the relevant information related to specification, installation checks and
acceptance criteria to be required for installation qualification activity.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following departments, shall be
responsible for the overall compliance of this Protocol cum Report:
DEPARTMENTS RESPONSIBILITIES
 Initiation, Approval, Compilation and Authorization of the Installation
Qualification Protocol cum Report.
Quality Assurance  Co-ordination with Production and Engineering to carryout Installation
Qualification.
 Monitoring of Installation Qualification Activity.
 Review & Pre Approval of Protocol cum Report.
 To Co-ordinate and support for Execution of Qualification study as per
Production
Protocol.
 Post Approval of Qualification Protocol cum report after Execution.
 Review & Pre Approval of Protocol cum Report.
 Co-ordination, Execution and technical support in Installation Qualification
Activity.
Engineering
 Calibration of Process Instruments.
 Responsible for Trouble Shooting (if occurs during execution).
 Post Approval of Qualification Protocol cum report after Execution.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

5.0 EQUIPMENT DETAILS:
Equipment Name Paste Kettle
Equipment ID.
Manufacturer’s Name Bectochem
Supplier’s Name Bectochem
Location of Installation Solution Preparation Room, Coating Area

6.0 SYSTEM DESCRIPTION:

Paste kettle is designed as per good manufacturing practice in terms of clean ability of components,
surface finish, absence of sharp corners, assembling and de-assembling of components and control
devices. Machine should be designed to be of jacketed type, electrically or steam heated, thermostatic
control with the unit, safety valve, insulated with suitable insulating material, tilting with hand wheel.
Easy transfer of paste while tilting, unit should be provided with suitable lid to discharge. Bottom valve
for steam water, which should be easily removable and easily cleanable.

MAIN FEATURES
 All contact part made of SS 316 as per GMP standard
 Hemispherical design for proper mixing of paste.
 Jacket provided with Steam/Electrical heating arrangement.
 Tilting arrangement for kettle is provided for discharge for starch paste.
 Anchor type impeller design for proper mixing of paste.
 Safe earthing system.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

7.0 PRE – QUALIFICATION REQUIREMENTS:

7.1 Verification of Documents :
 Executed and approved design qualification document.
 Piping and Instrumentation Diagram (P& ID).
 Electrical Circuits Diagram.
 Technical Specification of Equipment.
 Calibration Certificate of Components.
 Certificate of Material of Construction of Components.
7.1.1 Procedure:

 Verify the above mentioned documents for availability, completeness and approval status.

 If any deviation is observed the same has to be recorded giving reasons for deviation and approved.
Deviation should be approved by Authorized person.

 Approved Drawings and supporting documents would form a part of the IQ Protocol cum report.

7.1.2 Acceptance Criteria:

 All the documents should be available, complete and approved by respective authorities.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

8.0 CRITICAL VARIABLES TO BE MET:
8.1 General Checks & Checklist:
Observed By
Installation Checks Acceptance Criteria Observation (Engineering)
Sign/Date
Grouting And Mounting Should be grouted and
mounted properly.
Leveling Should be properly balanced
and leveled
Edges of Parts Metal edges should be
properly Rounded off without
any sharp edges.
Welding of Joints Welding of joints should be
without any welding burrs.
Place of Installation Solution Preparation Room,
Coating Area ,‘G’ Block
Illumination in area NLT 300 Lux.
Working space around Should be sufficient for easy
the equipment operation, cleaning, sanitation
and maintenance
Machine Inspection Ensure that all parts are
present and not damaged.
Electrical component Ensure that the electrical
verification components match to the
descriptions in D.Q

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: …………………… Sign/Date: ……………………

Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
Reviewed By
(Manager QA)
Sign/Date: ……………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

8.2 Utilities Provided:
Observed By
Parameters Acceptance Criteria Observation (Engineering)
Sign/Date

Utility connections should be available as per the manufacturer’s specification.

Electrical Supply 3 Phase

Voltage – 415 ± 10%
Frequency – 50 Hz ± 5%

Compress Air Supply

Flow Pressure 6 bar (kg/cm2)

Main Cable specification 50 mm2 copper, 4 core

Total Load 39.375 KW ( 52.5 HP)

Quality Oil, Water & Dust Free

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: …………………… Sign/Date: ……………………

Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
Reviewed By
(Manager QA)
Sign/Date: ……………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

8.3 MOC Verification List:
Observed by
S.No. Component MOC Observation (Engineering)
Sign/Date
1. Bowl SS 316
2. Top Dish SS 316
3. Impeller SS 316
4. Discharge Assembly SS 316
5. Safety Railing SS 304
6. Ladder SS 304
7. V belt STD
8. Gasket For Top Lid Food grade silicon
9. Operating Panel SS 304
10. pipe line RMG to FBD SS 316
11. Main Shaft SS 316L

12. Chopper Shaft SS 316L

13. Frame structure SS 304

Cladding and Covers

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: …………………… Sign/Date: ……………………

Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
Reviewed By
(Manager QA)
Sign/Date: ……………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

8.4 Drawing Verification:
Observed By
Available
Reference Engineering Drawings (Engineering)
(Yes/No)
Sign/Date
General arrangement Diagram

Power Circuit Diagram

Pneumatic Connections Diagram

Pneumatic Diagram for Solenoid valve

Panel Physical Layout

Circuit Diagram for PLC Controls

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: …………………… Sign/Date: ……………………

Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

Reviewed By
(Manager QA)
Sign/Date: ……………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

8.5 Equipment Verification:
8.5.1 Technical Specifications:

Observed By
Name of
Acceptance Criteria Observation (Engineering)
Components
Sign/Date
Capacity Working : 200 Ltr
Gross : 160 Ltr
Dimension 1275L x 1000 W x 1880 H in mm

All Contact Parts SS316

Non Contact Parts SS304

Motor  Make: REMI

 HP: 3 HP
 RPM: 1440
 VOLT: 415 ± 10%
 PHASE: 3PH
Gear Box  Make: “SUDARSHAN GEARS”
 Type: Worm Reduction Type
 Ratio: 30:1
Agitator  Shape: Anchor Type
 RPM: 30-200
 Shaft: SS 304
 Coupling: fanner type
 Sealing: single dry mechanical seal
Bowl Dimension  Shell : 700 mm ID x540 mm HT x
4 thk
 Jacket : 850 mm ID x 380 mm HT
x 2mm thk
 Cladding: 16 SWG fully covering
the jacket. Welding type
 Locking: 2 Nos. locking pins with
top cover to align
bowl in position
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

Observed By
Name of
Acceptance Criteria Observation (Engineering)
Components
Sign/Date
Tilting  Type : mechanical
Arrangement
 Hand wheel with bevel gear
arrangement
Nozzle Schedule  Jacket inlet with QRC- 25 BSP
 Safety valve : 15 BSP
 Jacket Outlet With QRC : 20 BSP
 Jacket Drain : 20 BSP- with blind
 Thermo well: 20 BSP- PT-100
Sensor
 Jacket Vent: 15 BSP- with needle
valve
 Bottom Outlet: 100 With Flush
Type Valve Manually Operated
 Steam inlet: 20 NB
Finish  Internal : 240 Grit mirror
 External: 180 Grit matt
Main Bowl & shell Make: BLPTPL
MOC: 10 SWG ( SS 316)
Jacket Bowl Make: BLPTPL
MOC: 10 SWG( SS 304)
Insulation Bowl Make: BLPTPL
MOC: 14 SWG( SS 304)
Stand Make: BLPTPL
MOC: 10 SWG( SS 304)
Dimension: 80 x 80 x10
Plummer Block Make: ZKL
MODEL: UCP-211
Top Lid Make: BLPTPL
MOC: 14 SWG( SS 316)
VFD For geared Make: ABB
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

Observed By
Name of
Acceptance Criteria Observation (Engineering)
Components
Sign/Date
motor Volt: 3 HP
Anchor blade & Make: BLPTPL
shaft
MOC: ( SS 316)
Dimension: 50x10 Thk
Dia: 55 Dia
Operating Panel Make: BLPTPL
Type: Non FLP, push button type
Safety Valve At Make: Spirex
Steam Line
MOC: Gun metal 15 B
Electric Actuated Make: Aira
Solenoid Valve At
MOC: ½ “BSP
Steam Line
Volt : 230 V AC
Gate Valve At Make: HVI
Steam Line
MOC: gun metal, ½ “ NB
Gate Valve at Make: HVI
condensate line
MOC: gun metal, ½ “ NB
Steam Trap At Make: HVI
Condensate Line
MOC: ½ “ NB

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: …………………… Sign/Date……………………
Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
Reviewed By
(Manager QA)
Sign/Date: ……………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

8.6 Installation Checks:
Observed By
S.No. Specification Observation (Engineering)
Sign/Date
1. Identification and verification of
major and sub components of Paste
Kettle.
2. Verification of system utility
requirements.
3. Check that all bolts are properly
tightened.
4. Ensure all Electric connections done
properly.
5. Ensure all mechanical adjustment.

6. Check that all Pneumatic

connections are properly fitted.

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: ………………… Sign/Date: …………………

Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

Reviewed By
(Manager QA)
Sign/Date: …………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

8.7 Safety:
Observed By
Checks Acceptance Criteria Observation (Engineering)
Sign/Date
Electrical wiring and Electrical wiring should be as
Earthing per approved drawings.
Double external earthing to
control machine (panel and
motors) and operator should
be provided.
MCB for overload Trip Should be provided for
equipment safety.
Emergency off: To stop the Should be provided For
process immediately equipment and operator safety

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: ………………… Sign/Date: …………………

Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

Reviewed By
(Manager QA)
Sign/Date: …………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

9.0 REFERENCES:
The Principle Reference is the following:

 Validation Master Plan

 Schedule-M – “Good Manufacturing Practices and Requirements of Premises, Plant and

Equipment for Pharmaceutical Products.”

 WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol-2 – Good

Manufacturing Practices and Inspection.

The following references are used for addition guidance:

 FDA/ISPE Baseline Pharmaceutical Engineering Guide-Volume 5:- Commissioning and

Qualification Guide, First Edition/March 2001.
 Code of Federal Regulations (CFR), Title 21, Part 210, Current Good Manufacturing Practice
(cGMP) in Manufacturing, Processing, Packing, or Holding of Drugs, Beta. April 1, 1998.
 Code of Federal Regulations (CFR), Title 21, Part 211, Current Good Manufacturing Practice
(cGMP) for Finished Pharmaceuticals, April 1, 1998.
 EU Guide to Good Manufacturing Practice, Part 4, 1997.
 European Commission’s working party on control of medicines and inspections document,
Validation Master Plan, Design Qualification, Installation & Operational Qualification, Non Sterile
Process Validation, Cleaning Validation, October 1999.
 GMP Guide, Validation of Automated Systems in Pharmaceutical Manufacture, Version 4.0,
December 2001.

10.0 DOCUMENTS TO BE ATTACHED:

 Technical details for Equipment Requirement with Engineering Drawings.
 Certificate of MOC
 Calibration certificates
 Operation and Maintenance Manual
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

11.0 DEVIATION FROM PRE-DEFINED SPECIFICATION IF, ANY:
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
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………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
12.0 CHANGE CONTROL, IF ANY:

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………

13.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY ):

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

14.0 CONCLUSION:
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
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15.0 RECOMMENDATION:
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

16.0 ABBREVIATIONS:
WHO : World Health Organization
FDA : Food and Drug Administration
CFR : Code of Federal Regulations
cGMP : Current Good Manufacturing Practices
DQ : Design Qualification
EU : European Union
SS : Stainless Steel
Kg : Kilogram
mm : Millimeter
HP : Horse Power
V : Volt
Hz : Hertz
QA : Quality Assurance
IQ : Installation Qualification
CFM : Cubic Feet per Minute
RMG : Rapid mixer granulator
MOC : Material of construction
NLT : Not less than
HP : Horse power
KW : Kilo watt
SS : Stainless steel
PLC : Programmable logical control
Kg : Kilo gram
MCB : Miniature circuit break
PTS : Powder transfer system
HMI : Human machine interface
FBD : Fluid bed dryer
Id : Inner diameter
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR PASTE KETTLE

17.0 POST APPROVAL:

INITIATED BY:
DESIGNATION NAME SIGNATURE DATE

OFFICER / EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(PRODUCTION)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)