IQ Aquaklenz Ampoule Washer - Doc Update

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L.B.S. LABORATORY L.P.
Installation Qualification Protocol
Equipment : Protocol No. : Effective Date : 25-12-2020

AQUAKLENZ ROTARY AMPOULE WASHER IQ-K7 : QA-VC-002
MODEL CMAW 20X4
Facility : Location : Revision :

L.B.S. LABORATORY L.P. K7 Washing Sterilization and 00
Cooling Room no.110
Title :
INSTALLATION QUALIFICATION OF AQUA KLENZ AMPOULE WASHER
Approval of this Qualification Protocol is joint responsibility of the following functional area:
Name Designation Signature Date
Written by Ms. Wanida Chainariang Validation staff
Reviewed by Ms. Saifone Harnchanaphol Validation coordinator
Mr. Panuwat Rungraksathum Head of Project Engineer

Reviewed by
Team
Reviewed by Mr. Jai Prakash Maurya Acting Head of Sterile
Section
Approved by Mr. Wara Jivatadavirute QA Manager
TABLE OF CONTENTS
Installation Qualification
AQUAKLENZ ROTARY AMPOULE WASHER

Protocol No. : IQ-K7 : QA-VC-002 Revision : 00
MODEL CMAW 20 X 4
Code : SP-WA-01 Effective date : 25/12/2020 Page : 1/32
PAGE
1.0 OVERVIEW..................................................................................................................................3
2.0 SCOPE..........................................................................................................................................3
3.0 IQ EXECUTION TEAM AND SIGNATURE VERIFICATION......................................................3
4.0 REFERENCE DOCUMENT...........................................................................................................4
5.0 RESPONSIBILITIES....................................................................................................................4
6.0 SYSTEM DESCRIPTION.............................................................................................................5
7.0 DEFINITIONS..............................................................................................................................5
8.0 TRAINING REQUIREMENTS......................................................................................................6
9.0 TEST FUNCTIONS......................................................................................................................6
9.1 TEST FUNCTION NUMBER ONE: DOCUMENT AND DRAWING VERIFICATION.................6
9.2 TEST FUNCTION NUMBER TWO : MACHINE VERIFICATION...............................................8
9.3 TEST FUNCTION NUMBER THREE: LEVELLING VERIFICATION.........................................9
9.4 TEST FUNCTION NUMBE FOUR; MOC VERFICATION.........................................................10
9.5 TEST FUNCTION NUMBER FIVE: ELECTRICAL COMPONENT VERIFICATION.................11
9.6 TEST FUNCTION NUMBER SIX : LOCATION OF INSTALLATION VERIFICATION..........12
9.7 TEST FUNCTION NUMBER SEVEN: UTILILTIES VERIFICATION...........................................13
9.8 TEST FUNCTIN NUMBER EIGHT : CRITICAL INSTRUMENTS CALIBRATION REVIEW.......14
9.9 TEST FUNCTIN NUMBER NINE : OVERALL INSTALLATION VERIFICATION........................15
9.10 TEST FUNCTION NUMBER TEN: COMPONENT CERTIFICATION AND CALIBRATION......16
9.11 TEST FUNCION NUMBER ELEVEN : COMPONENT LIST VERIFICATION............................17
10.0 SAFETY REVIEW.......................................................................................................................27
11.0 DEVIATION HANDLING...........................................................................................................30
12.0 SUMMARY REPORT AND CONCLUSION..............................................................................31


MODEL CMAW 20 X 4
13.0 ABBREVIATIONS......................................................................................................................32
14.0 ATTACHMENTS.........................................................................................................................32

MODEL CMAW 20 X 4
1.0 OVERVIEW
Introduction
AquaKlenz ampoule washer will wash ampoules of 1-2 ml size in a Class D environment and under
Laminar flow hood (class A) to provide essentially clean and particles free ampoules to be
transferred into the sterilizing and depyrogenating tunnel.
Objective
To verify that the AquaKlenz has been assembled in accordance with the Design Qualification
documents and in accordance with Good Manufacturing Practices (GMP).
2.0 SCOPE
This procedure is applicable to the AquaKlenz rotary ampoule wash installed at the sterile
production floor at LBS Laboratory K7.
3.0 IQ EXECUTION TEAM AND SIGNATURE VERIFICATION
Following personnel are involved in the completion of this project with defined responsibilities as
follows :
Print name Designation Department/ Signature Date

Company name
Ms. Wanida Chainariang Validation officer VC/ QA/ LBS
Ms. Saifone Harnchanaphol Validation coordinator VC/ QA/ LBS
Mr. Panuwat Rungraksathum Head of Project MN/MN/LBS
Engineer Team
Mr. Jai Prakash Maurya Acting head of Sterile SP/FA/LBS


MODEL CMAW 20 X 4
4.0 REFERENCE DOCUMENT
Following documents are referred during preparation of this protocol.
Document name Document number

Design qualification KCC/W 20X4/DQ-058
Offer No. RPL/KCC/STW-03-12/2546 R2 Dated 27-01-2012
Purchase Order no. IA-1-006/2012 Dated 15-3-2012
Operation and maintenance manual ------
5.0 RESPONSIBILITIES
Responsibilities of personnel involved in different activities related to the installation qualification
of the Pure Steam Generator are defined below:
Functions Responsible person Position

Preparation of IQ document Ms. Wanida Chainariang Val. staff
Review of IQ document Ms. Saifone Harnchanaphol Validation coordinator
Review of IQ document Mr. Panuwat Rungraksathum Head of Project Engineer Team
Review of IQ document Mr. Charakorn Ariyakabooth Plant engineer
Review of IQ document Mr. Jai Prakash Maurya Acting Head of Sterile Section
Approval of IQ document Mr. Wara Jivatadavirute QA manager
Clearance of the equipment for Mr. Panuwat Rungraksathum Head of Project Engineer Team
Components
execution check Mr. Panuwat Rungraksathum/ Head of Project Engineer Team/
personnel
Ms. Wanida Chainariang Val. Staff
Review of executed IQ document Ms. Saifone Harnchanaphol Validation coordinator
Review of executed IQ document Mr. Panuwat Rungraksathum Head of Project Engineer Team
Review of executed IQ document Mr. Jai Prakash Maurya Acting Head of Sterile Section
personnel
Approval of executed IQ document. Mr. Wara Jivatadavirute QA manager

MODEL CMAW 20 X 4
6.0 SYSTEM DESCRIPTION
6.1 General description

The AquaKlenz ampoules washer is to provide clean and particle free ampoules for pharmaceutical
manufacturing use. The washer will have the following functions:
 Ultrasonic Bath
 Vial Rinse with Recycled Water
 Vial Rinse with USP Water
 Filtered Air Blow-Off
The ampoule washer is a stand-alone unit, floor mounted and can be run independently or when
connected to a tunnel, as a compact line.
6.2 Wash schematics
Sr No. Major components description

1 Infeed Loading mesh conveyor
2 Ultrasonic cleaning bath having immersion ultrasonic transducer
3 Infeed warm screw
4 Infeed star wheel to index the ampoules
5 Ampoule cassettes which form the pick and transfer mechanism
6 Set of nozzles provided for various wash media, typically, Recycled water
Compressed air and WFI
7 Outfeed star wheel at the discharge
8 Outfeed connected to Drying zone of tunnel
7.0 DEFINITIONS
1.1 Critical component : Component within a system where the operation, contact, data, control,
alarm, or failure may have a direct impact on the manufacturing parameters which in turn affect
the product quality.
1.2 Non-critical components : Component within a system where the operation, contact, data,
control, alarm, or failure will have an indirect impact, or no impact, on the manufacturing
parameters which in turn affect the quality of the product.
1.3 Deviation : Any event (planned or unplanned) that has the potential to adversely impact product
quality. Deviation may or may not have the potential to impact operations and operational costs.

MODEL CMAW 20 X 4
1.4 Variance : Any event (planned or unplanned) that has the potential to impact operations and
operation cost and no impact on product quality.
8.0 TRAINING REQUIREMENTS
Identify the training need for Operating Personnel

Sr. No. Subject
1 Component Identification
2 Operation and maintenance of the AquaKlenz rotary ampoules washer
3 Safety feature of the Rotary Washer
9.0 TEST FUNCTIONS
9.1 TEST FUNCTION NUMBER ONE: DOCUMENT AND DRAWING VERIFICATION
Objective : To verify that the documentation provides complete and corrected technical
references and permits servicing of the units
Procedure :
Verify that the required documents and drawings listed in the tables below are available.
Review the documents and drawings for completeness and exactness with the installed unit.
Sign and date all copies of the drawings, once verification is completed.
Attach the copies of the drawings to this protocol or reference the location from where they
can be easily retrieved.
Any items in the installation, which are not conforming to the corresponding drawings, must
be commented on in the appropriate space. List the non-conformances and the reasons for
them in an attachment are needed.
Acceptance Criteria :
All documents are present.
The documents must be accurate and complete.
The drawing information must correspond to the physical installation

MODEL CMAW 20 X 4
Drawing Verification
Sr. Title Doc’s No. revision date Present

No. and location Yes No.
1 GA Drawing of Ampoule washer DRG NO: KAW-20X4-MO1
2 Ampoule Washer (20x4) Assembly drawing 1 DRG NO: KAW-20X4-A01
3 Infeed / outfeed Assembly Drawing DRG NO: KAW-20X4-A02
4 Conveyor Assembly Drawing DRG NO: KAW-20X4-A03
5 Screw Assembly Drawing DRG NO: KAW-20X4-A04
6 Main Drive assembly drawing DRG NO: KAW-20X4-A05
7 P&ID for Continuous Motion Ampoule Washer DRG NO: KAW-20X4-LBS-02
8 GA Drawing for ampoule line DRG NO: KCCL-2546-02
9 Control Wiring Diagram DRG NO : K-WT-E49-50
10 Power Wiring Diagram DRG NO : K-WT-E40-48
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Meet the acceptance criteria? ( ) yes ( ) No.
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
9.2 TEST FUNCTION NUMBER TWO : MACHINE VERIFICATION
Objective :
To ensure that all parts of the Ampoule Washer are present, identified and not damaged.
Procedure :
Confirm that identification name plates have been applied to the units and indicate the type,
tag no. manufacturer, Model No.
Confirm that various components of ampoule washer are presented as per drawings, in the
proper numbers and configuration.
Visually examine the ampoule washer for defects.
Acceptance criteria :
Each item listed in the following table is present and documented. There is no visible defects
on the Ampoule Washers.
Factory assembled Free of Defects

Sr. No Description
Yes No. Yes No.
1 Infeed Loading Conveyor

2 Infeed indexing screw
3 Guide Railings
4 Machine Drive
5 Cassettes
6 Nozzles
7 Spray Beams
8 Re-circulatory Water Tank
9 Purified Water Tank
10 Filter housing (WFI, Air, PW& RCW)
11 Filter for water
12 Filter for air
13 Pressure gauges
14 Pressure Transmitters
15 Temperature sensor
Sr. No Description Factory assembled Free of Defects

MODEL CMAW 20 X 4
Yes No. Yes No.

16 Level switch
17 Ultrasonic Cleaning system
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Meet the acceptance criteria? ( ) Yes ( ) No.
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……
9.3 TEST FUNCTION NUMBER THREE: LEVELLING VERIFICATION

Objective :
To ensure that ampoule washer is placed to proper location and leveled correctly.
Test equipment : Spirit Level Indicator / water level indicator
Procedure :
Check the layout drawing to ensure the proper positioning of the ampoule washer, found in the
final documentation file. Place the spirit level indicator at different points in the machine frame
for level checks. Place transparent tube filled with water at suitable length at various corners
for alignment check.
The machine is properly levelled
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
9.4 TEST FUNCTION NUMBE FOUR; MOC VERFICATION
Objective :To ensure that actual material of construction and finishes of ampoules washer
match those specified by Design qualification.
Procedure : Determine the specified MOC and finished of the Ampoule Washer from the notes
on the assembly drawing or the Material Verification Certificate found in the final documents
file. Record in the table provided below.
Acceptance criteria : the MOC matches the DQ or URS specification
Material of Construction and Finishing list
Sr No. Item Specification Product

contact
AISI 316 L SS  YES NO

1 Infeed loading conveyor
SS Square Bar  YES NO
2 Machine Stand
3 Guide Railings
SS 316 L + NYLOCAST  YES NO
4 Infeed Star wheel
UHMWPE  YES NO
5 Outfeed Star wheel
EPDM  YES NO
6 Gripper
Delrin  YES NO
7 Infeed Indexing wheel
8 Spray Nozzle
9 Spray Pipe
Silicon braided (Food Pharma grade)  YES NO
10 Flexible Pipe
11 Cassettes
12 Collection bowl
13 Reciprocating ring
14 Water tank
15 Interconnecting piping
16 Filter Housing

MODEL CMAW 20 X 4
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……
9.5 TEST FUNCTION NUMBER FIVE: ELECTRICAL COMPONENT VERIFICATION
Objective :
To ensure that the electrical components installed on the Ampoule Washer match the
descriptions of those specified on the DQ documents.
Test equipment : multi meter
Procedure : Compare the description of all specified electrical components and instruments
( i.e. motor starter, inverter, drive etc) found on the DQ documents with actual electrical
components installed on the machine.
Acceptance Criteria :
The electrical components specified match those installed
Description Verified
Correct installation of main control panel  YES  NO
All electrical components checked and free from defects  YES  NO
All control circuits are checked and found correct  YES  NO
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
9.6 TEST FUNCTION NUMBER SIX : LOCATION OF INSTALLATION VERIFICATION
Objective :
To verify the location of installation as per the equipment layout with respect to room, found in
DQ document
Procedure :
Check that equipment is installed in the room specified in the Ampoule Washer general
arrangement layout and room layout drawings.
Check the assembly of other components as per General Arrangement drawing
Location of installation is verified
Sr No. Particular Specification Actual Meet spect.
1 Overall dimension 3930x1945x1300  YES  NO
2 Washing machine 2280x1945x1300  YES  NO
3 Wash schematic 1300x1115x1200  YES  NO
4 Room of installation Room no.110  YES  NO
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
9.7 TEST FUNCTION NUMBER SEVEN: UTILILTIES VERIFICATION

Objective : To verify that all necessary utilities are correctly installed.
Test equipment: Calibrated digital multi-meter and air pressure gauge.
Procedure : Confirm the utilities connections are configured as per specification found in the
DQ documents and in compliance with the local codes. Record the results in the table below.
Acceptance criteria : The utilities connect match DQ specification and local codes.
Sr Description Specified ( Approximately) Measured result Meet spect.

No.
1 Electrical supply 380-415 V,50 Hz, 3PH  YES  NO

2 Compressed air 10N CuM/Hr. @ ≥ 6 Bar g  YES  NO
3 WFI ≥ 2 Bar  YES  NO
4 PW ≥ 2 Bar  YES  NO
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
9.8 TEST FUNCTIN NUMBER EIGHT : CRITICAL INSTRUMENTS CALIBRATION REVIEW

Objective: To verify that all critical instruments for the ampoule washer have been calibrated
before starting the operation qualification.
Procedure: Confirm that all critical instruments are calibrated with traceability. Attach copies
of calibration certificates to this protocol. Record the results in the table below:
All critical instrumentations for the ampoule washer shall be in a state of calibration.
Sr Calibration
Item Frequency of calibration
No.
Yes No.
1 Pressure gauges
2 Pressure transmitters
3 Temperature sensors
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
9.9 TEST FUNCTIN NUMBER NINE : OVERALL INSTALLATION VERIFICATION

Objective: To verify that the Ampoule Washer have been installed before starting the
operation qualification
Procedure: Confirm that all ampoule washer is ready for conducting Operation Qualification.
Record the results in the table below:
Acceptance criteria :All checks are conducted at real time and found satisfactory.
Sr. No. Description Checked
1 Ampoule Washer positioned properly as per drawing and leveled  YES  NO

2 Sufficient space for men, material movements  YES  NO
3 Pump motor direction of rotation  YES  NO
4 Washing nozzle mounting position  YES  NO
5 Cassettes assembly  YES  NO
6 Guides mounting  YES  NO
7 Vibrations of the unit  YES  NO
8 Leakages in system  YES  NO
9 Pressure transmitter functioning  YES  NO
10 Functioning of all the sensors and related inter locks  YES  NO
11 Utility verification as per requirement  YES  NO
12 Solenoid valve operation  YES  NO
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
9.10 TEST FUNCTION NUMBER TEN: COMPONENT CERTIFICATION AND CALIBRATION

Objective : This is to verify the Test certificate and Calibration certificates of the designated
components. Check whether the certificate corresponds to the installed component.
Procedure : Compare the make, model no. and other specifications from the certificate with
the specifications of the component and in table below
Acceptance criteria : All checks are conducted at real time and found satisfactory
Sr. Components to be calibrated Serial No./ID Certificate No.

No No.
Name Location
1 Temperature sensor for Recirculatory water I-212053874
KCCL-003
recirculatory water (RTD1) tank
2 Temperature sensor for purified Purified water tank I-212050782
KCCL-003
water (RTD2)
3 Pressure transmitter for WFI (PT2) WFI line 19111110037 -
4 Pressure transmitter for PW (PT1) PW line 19111110048 -
5 Pressure transmitter for re- Recirculatory water
19111110040 -
circulatory water (PT4) path
6 Pressure transmitter for Air path
K13250398 -
compressed air (PT3)
7 Pressure gauge for recirculatory Recirculatory Path
516661 -
WFI (0-4 kg/cm2 ) (PG4)
8 Pressure gauge for WFI WFI line
(0-4 kg/cm2 ) (PG2) 518598 -
9 Pressure gauge for PW PW line

516660 -
(0-4 kg/cm2) (PG1)
10 Pressure gauge for compressed air Air path
312268 -
(0-4 kg/cm2) (PG3)
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
9.11 TEST FUNCION NUMBER ELEVEN : COMPONENT LIST VERIFICATION

Objective : To verify the components installed
Procedure : Check the component name and tag no. against the DQ specification.
Acceptance criteria : The actual component installed match those on the DQ specification.
Instrument / Component verification
Sr Description Tag no. Specification (used) Verified

no.
1 Motor for rotary axis Make : Allen Bradley  YES  NO

Type : Servo motor
Cat no. : MPM-B1152C-MJ72AA
Details : 1.2/1.61 KW/HP,3000 RPM
Sr. No. : 21886786
QTY : 01 No.
2 Gear box for rotary axis Make : SHIMPO  YES  NO
Model : VRL-120B-70-K5-19FC19
Ratio : 1:7
Sr. No. : 21220781
QTY : 01 No.
3 Motor for Oscillation Axis Make : Allen Bradley  YES  NO
Type : Servo motor
Power : 2.6 KW, 4000 RPM
Cat No. : MPL-B4530K-MJ72AA
QTY : 01 No.
Sr. No. : 21851487
4 Gear box for Oscillation Axis Make : ALPHA  YES  NO
Model : TP050S-MA3-88-0G1
Ratio : 88:1
Sr. No. : 21220781
QTY : 01 No.

MODEL CMAW 20 X 4

no.
5 Motor for Up-Down Axis Make : Allen Bradley  YES  NO

Type : Servo motor
Power : 3.2 /4.4 KW/HP,, 3000 RPM
Cat No. : MPL-B4560F-MJ74AA
QTY : 01 No.
Sr. No. : 21056005
6 Gear box for Up-Down Axis Make : APEX  YES  NO
Model : ADR140-035-P0
Ratio : 35:1
QTY : 01 No.
7 Motor for Star wheel Make : Allen Bradley  YES  NO
Type : Servo motor
Power : 1.5/2.0 KW/HP,, 5000 RPM
Cat No. : MPL-B320P-MJ72AA
QTY : 01 No.
Sr. No. : 21172096
8 Gear box for star wheel Make : SHIMPO  YES  NO
Model : VRL-120B-70-K5-L9FAL9
Ratio : 50:1
QTY : 01 No.
Sr. No. : 21231361
9 Motor for infeed warm screw Make : Allen Bradley  YES  NO
Type : Servo motor
Power : 3.2/4.33 KW/HP,3000 RPM
Cat No. : MPL-B4560F-MJ72AA
QTY : 01 No.
Sr. No. : 21734856

MODEL CMAW 20 X 4

no.
10 Gear box for infeed warm Make : Rotomotive  YES  NO

screw Type : Box 040
Ratio : 7.5:1
QTY : 01 No.
11 Level switch Make : Balaji Auto Systems  YES  NO
Model : VMT-16-L-Bend
QTY : 3 Nos.
12 Diaphragm valve DSV-14,DSV- Make : ITT  YES  NO
1, Type : Diaphragm type
DSV-5,DSV- Actuated valve
10, Model : DN-25 B209
DSV-3,DSV-7, QTY : 10 Nos.
DSV-9,DSV- Sr. No. : 903489-001-005,
12, 903489-001-006,
DSV-11,DSV- 903489-001-007,
2 903489-001-010,
903489-001-014,
903489-001-002,
903489-001-001,
903489-001-003,
903489-001-012,
903489-001-011
Model : DN-15 B206
QTY : 05 Nos.
Sr. No. : 903489-002-003,
903489-002-001,
DSV-13,DSV- 903489-002-004,
8, 903489-002-002,
DSV-4,DSV-6, 903489-001-002,
DSV-15

MODEL CMAW 20 X 4

no.
13 Water pump SP1 , SP2 Make : INOXPA  YES  NO

Type : SE-20
Power : 2.2 KW, 2840 RPM
Sr. No. : I-144019J, I144018H
14 FRL FRL Make : Festo  YES  NO
Model : LFR-D-mini+LOE-D-mini
Range : 0-16 Bar
Qty : 1 No.
15 Temp. Sensor RTD-1, RTD- Make : Radix  YES  NO
2 Range : 0-250 °C
PT 100 3 WIRE
Size : 100mm, Length 6mm OD
Qty : 2 Nos.
Sr. No. : I-212053784,
I-212050782
16 Pressure transmitters PT-1, PT-2, Make : Gefran  YES  NO
PT-3, PT-4 Model : KS-E-E-E-BO1D-M-V
Range : 0-10 Bar
Output : 4-20 mA
Qty : 4 Nos.
Sr. No. : I9111110040,
I9111110048,
I9111110037,
K13250398
17 Solenoid for Diaphragm valve Make : Festo  YES  NO
Model : MFH-3-1/ 8SEU
QTY : 15 Nos.
Range : 0.5 – 80 bar, 6.9 – 120 PSI

MODEL CMAW 20 X 4

no.
18 Filter for re-circulatory water FRW Make : Millipore  YES  NO

Type : HI07 101 15
Qty : 1 No.
19 Filter for compressed air FCA Make : Domnick Hunter (Parker)  YES  NO
Type : 0.1µ, Code 7 Fitting
Qty : 1 No.
20 Filter housing with gauge WFIFH,AF,P Make : Millipore  YES  NO
WFH,RWFH Cat No. : HI07 101 15
Description : Single Place10” Housing
Qty : 4 Nos.
21 PLC Make : Allen Bradley  YES  NO
Model : Compactlogix L33ERM
Cat No. : 1769-L33ERM
22 HMI (common with tunnel) Make : Allen Bradley  YES  NO
Model : Panel View plus 1000
Cat No. : 2711P-RDT10C Ser B
23 Servo drive for rotary Axis Make : Allen Bradley  YES  NO
Model : Kinetix 6000
Cat No. : 2094-EN02D-M01-S0
Sr.No. : 21746601
24 Servo drive for oscillatory Make : Allen Bradley  YES  NO
axis Model : Kinetix 6000
Cat No. : 2094-BMO2-M
Sr.No. : 21800312
25 Servo drive for up-down axis Make : Allen Bradley  YES  NO
Cat No. : 2094-BMO2-M
Sr.No. : 21746575

MODEL CMAW 20 X 4

no.
26 Servo drive for Star wheel Make : Allen Bradley  YES  NO

axis Model : Kinetix 6000
Cat No. : 2094-BMP5-M
Sr.No. : 21800326
27 Servo drive for infeed screw Make : Allen Bradley  YES  NO
Cat No. : 2094-BM02-M
Sr.No. : 23618238
28 Ultrasonic system Make : Branson  YES  NO
•Transducer
Model : CB1016-40-18C
Power : 750 watt (18 T)
Qty : 2 Nos.
Sr. No. : S8540-36
•Power Supply
Model : S 8540936
Power : 1500 watt,60Hz208/240v
EDP : 101-132-494
Sr. No. : GFK1303SBU2219
29 Gear box motor for infeed Make : Bonfiglioli  YES  NO
conveyor Type : BN71A4
Power : 0.25 KW,1380 RPM
Code No.: 830620106
Sr. No. : 3233010036
Gear No.
Type : VF44 VP71B5
Ratio : 35 : 1
Sr. No. : 163778950005

MODEL CMAW 20 X 4

no.
30 Proximity switch Make : SICK  YES  NO

Model : IME12-04BPSZU3S
Qty : 1 No.
31 Limit switch Make : NUX  YES  NO
Model : LS803RN
32 Photo sensor for counting Make : Wenglor  YES  NO
Model : HK12PA
Type : PNP-NNO,Reflex sensor
with Background
suppression
Qty : 1 No.
33 Photoelectric switch Make : Electronic switches Nashik  YES  NO
Model : IFS 203/4
Type : PNP-NO
Range : 20 mm
Qty : 4 Nos.
34 Water Heater IH-1,IH-2 Make : Heatrays Technologies  YES  NO

Type : Immersion
Power : 3 K watt
Qty : 2 Nos.
35 I-gush Bush ( for Cassette) Make : I-gush  YES  NO
Part No. : HFM-0810-09
36 Bearing for Infeed Lifting Make : KID  YES  NO
Starwheel Block Part No. : G146-35R
Ref No. : CF6WBR

MODEL CMAW 20 X 4

no.
37 Blower Motor BM-100 Make : Klenzaids  YES  NO

Power : 0.75 KW,1HP,2880
RPM,415 V,3 Phase
Qty : 1 No.
Sr. No. : 011M / 0513
Recommended spares Parts list

no.
1 Gear motor for Infeed Make : Bonfiglioli  YES  NO

conveyor Type : BN 71A4
Power : 0.25KW, 1380RPM
2 Water Pump Make : INOXPA  YES  NO
Type : SE-20
Power : 2.2KW
Qty : 1 No.
3 FRL Make : Festo  YES  NO
Model : LFR-D-Mini+LOE-D-mine
Range : 0-16 Bar
Qty : 1 No.
4 Temp.Sensor Make : Radix  YES  NO
Range : 0-250 °C
Size : 100 mm,Length 6mm OD
Qty : 1 No.
5 Proximity sensor Make : Teknic  YES  NO
Model : EGT12X04
Qty. : 1 No.

MODEL CMAW 20 X 4

no.
6 Pressure transmitter Make : Gefran  YES  NO

Model : KS-E-E-E-BO1D-M-V
Range : 0-10 Bar
Qty : 2 Nos.
7 Cassettes Make : Klenzaids  YES  NO
Model : Four finger for Ampoule
Qty. : 3 No.
8 Gripper (for Cassette finger) Make : Klenzaids  YES  NO
MOC : EPDM
Qty. : 50 Pcs
9 Cassettes Springs Make : Klenzaids  YES  NO
MOC : SS-316
Qty. : 100 Pcs
10 Cassettes Opening Roller Make : Klenzaids  YES  NO
MOC : Nylocast
Qty. : 50 Nos.
11 Spray Nozzles Make : Klenzaids  YES  NO
Model : For 1 ml Ampoule
Qty. : 20 Pcs
12 Filter Water Make : Millipore  YES  NO
Type : Cartridge filter,code-7
Fillting
Size. : 10” Long 10 Micron
Qty. : 1 No.
13 Air Filter Make : Domnick Hunter  YES  NO
Part No. : KA 0071
Qty. : 1 No.
14 O-Ring (For Nozzle spray) Make : Klenzaids  YES  NO
MOC : Silicone
Qty. : 50 Pcs

MODEL CMAW 20 X 4

no.
15 Bush (For Casstte) Make : I-gush  YES  NO

Qty. : 40 Pcs
16 Infeed Lifting Block Make : Klenzaids  YES  NO
Qty. : 2 Nos.
17 Boarding for Infeed Lifting Make : IKD  YES  NO
Starwheel P.N. : G146-35R
Ref No. : CF6WBR
18 Photo electronic switch Make : Nashik  YES  NO
Model : IFS 203/4
Brown : +ve 10 to 30 V DC
S/N : 1307296
Qty. : 1 No.
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
10.0 SAFETY REVIEW
Objective :
To verify and document all actual or potential safety issues associated with this equipment.
Procedure :
10.0.1 Complete the applicable attachment indicating which safety specification is applicable to
the equipment.
10.0.2 Document any discrepancies in the Deviation Report Log.
All safety information shall be identified and documented.
Hazop Review and Checklist

Indicate which of the safety specifications listed below are applicable. For those indicated, record the
specific measures to take to verify their completion.
New Equipment Safety Review

Walk through conducted [ ] YES [ ] NO [ ] N/A
HAZOP REVIEW [Hazard and operability analysis]
Conducted by: ________________________ Date: __________ Location: ________________
Extreme Temperature: Applicable [ ] YES [ ] NO

All Hot Lines/Equipment Insulated: [ ] YES [ ] NO [ ] N/A
Personnel Protection Available: [ ] YES [ ] NO [ ] N/A
Heat Sources Shielded and Identified: [ ] YES [ ] NO [ ] N/A
Signs Posted to Alert Operators that Surface is HOT: [ ] YES [ ] NO [ ] N/A
Pressure Considerations: Applicable [ ] YES [ ] NO
All piping properly aligned [ ] YES [ ] NO [ ] N/A
Pressure rating of piping components is compatible with SOP [ ] YES [ ] NO [ ] N/A
Pressure relief devices provided where applicable [ ] YES [ ] NO [ ] N/A
Compressed AIR/GAS lines can be isolated and blend to zero energy state. [ ] YES [ ] NO [ ] N/A
ASME stamps [ ] YES [ ] NO [ ] N/A
Location: ______________________________________________

MODEL CMAW 20 X 4
Hazardous Materials of Fluids: Applicable [ ] YES [ ] NO

If hazardous materials are applicable, attach Material Safety Data Sheet(s) to this report.
MSDS attached [ ] YES [ ] NO [ ] N/A
If required, SOP’s for safe handling written [ ] YES [ ] NO [ ] N/A
Location: _______________________________________________________
Spill retention provided [ ] YES [ ] NO [ ] N/A
Toxic and Flammable Chemical Risks Controlled [ ] YES [ ] NO [ ] N/A
Biohazards contained [ ] YES [ ] NO [ ] N/A
Electrical Hazards: Applicable [ ] YES [ ] NO

All wiring properly contained [ ] YES [ ] NO [ ] N/A
All systems properly grounded [ ] YES [ ] NO [ ] N/A
Lock out’s available on all major equipment [ ] YES [ ] NO [ ] N/A
Specify types and locations: _______________________________________________________

Proper shielding provided [ ] YES [ ] NO [ ] N/A
Moving Parts: Applicable [ ] YES [ ] NO

Guards provided and in place at pinch points [ ] YES [ ] NO [ ] N/A
Guards provided and in place over moving parts [ ] YES [ ] NO [ ] N/A
Cut down lock nuts on shaft [ ] YES [ ] NO [ ] N/A
Belt tension properly adjusted [ ] YES [ ] NO [ ] N/A
Physical Environmental: Applicable [ ] YES [ ] NO

Sharp edges removed or protected [ ] YES [ ] NO [ ] N/A
Trip/fall hazards eliminated or protected against [ ] YES [ ] NO [ ] N/A
Low clearance head space clearly indicated or eliminated [ ] YES [ ] NO [ ] N/A
Equipment properly anchored [ ] YES [ ] NO [ ] N/A
Eye hazards eliminated [ ] YES [ ] NO [ ] N/A
Adequate lighting in area [ ] YES [ ] NO [ ] N/A

MODEL CMAW 20 X 4
Warning and precautionary signs where appropriate [ ] YES [ ] NO [ ] N/A

Adequate Ventilation [ ] YES [ ] NO [ ] N/A
Confined space eliminated or labeled [ ] YES [ ] NO [ ] N/A
Dust Levels: Applicable [ ] YES [ ] NO

Particulate matter concentration results [ ] YES [ ] NO [ ] N/A
Location: ____________________________________________________
Respiratory equipment/device in place, if required [ ] YES [ ] NO [ ] N/A
Noise Levels: Applicable [ ] YES [ ] NO

Noise level is ________________dB
Noise reduction equipment/device in place, if required. [ ] YES [ ] NO [ ] N/A
Ergonomic Design: Applicable [ ] YES [ ] NO

Ergonomic risks evaluated, operators can access all areas of machine [ ] YES [ ] NO [ ] N/A
Adequate operator visibility [ ] YES [ ] NO [ ] N/A
Emergency stop buttons visible, accessible, labeled, and operational [ ] YES [ ] NO [ ] N/
Warning bells and lights visible and functional [ ] YES [ ] NO [ ] N/A
Belt/conveyor/table width not operational without safety guard [ ] YES [ ] NO [ ] N/A
Hazardous equipment not operational without safety guard [ ] YES [ ] NO [ ] N/A
Excessive reaching, body bending, weight pushing and pulling eliminated or minimized
[ ] YES [ ] NO [ ] N/A
Personnel protective equipment to be worn while operating is indicated. Include requirements.
Requirements location: __________________________ [ ] YES [ ] NO [ ] N/A
Comment : …………………………………………………………………………………………………………………………...
…………………………………………………………………………………………………………………………………………...
Meet the acceptance criteria? ( ) yes ( ) No.
Checked by ………………………………………………….. Date ……………………………………….……
Reviewed by…………………………………….……………. Date ……………………………………….……


MODEL CMAW 20 X 4
11.0 DEVIATION HANDLING
Objective
To document any deviation to the stated test procedure or acceptance criteria, and to evaluate
the deviation relative to acceptability of the qualification study.
Procedure
Document all deviations found during execution using the Deviation Report Form.
In case of deviation follow SOP NO. QA-QI-008
Completed Deviation Report Forms are submitted to QA for signature acceptance.
Deviation Report Form
Evaluation / Assigned
Action shall Verified Action Approved
Sr No. Deviation Corrective Date for
be taken by by Completed By
Action Completion
 YES  NO
 YES  NO
 YES  NO
 YES  NO

MODEL CMAW 20 X 4
12.0 SUMMARY REPORT AND CONCLUSION
Summary report :
The following test function were checked during execution this protocol.
Meets Acceptance Criteria
Test function#1: Document and drawing verification  YES  NO

Test function#2: Machine verification  YES  NO
Test function#3: Levelling verification  YES  NO
Test function#4: Material of construction verification  YES  NO
Test function#5: Electrical Component verification  YES  NO
Test function#6: Location of installation verification  YES  NO
Test function#7: Utilities verification  YES  NO
Test function#8: Critical instrument calibration review  YES  NO
Test function#9: Overall Installation verification  YES  NO
Test function#10: Component Certification and Calibration  YES  NO
Test function#11: Component list verification  YES  NO
Conclusion :
 1. Machine conforms with the requirements of installed components and it is released for next step of
Qualification.
 2. Machine does not conform with the requirements of installed components and it is not released for
next step of Qualification until all deviations are attended and certified.
Written by …………………………………..…………… Date ………………………………………………………………
Reviewed by ……………………………………………… Date ………………………………………………………………


MODEL CMAW 20 X 4
13.0 ABBREVIATIONS
14.0 ATTACHMENTS
Attachment no Description

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L.B.S. LABORATORY L.P.

Installation Qualification Protocol

Equipment : Protocol No. : Effective Date : 25-12-2020

Facility : Location : Revision :

Name Designation Signature Date

Written by Ms. Wanida Chainariang Validation staff

Reviewed by Ms. Saifone Harnchanaphol Validation coordinator

Mr. Panuwat Rungraksathum Head of Project Engineer

AQUAKLENZ ROTARY AMPOULE WASHER

Code : SP-WA-01 Effective date : 25/12/2020 Page : 1/32

3.0 IQ EXECUTION TEAM AND SIGNATURE VERIFICATION......................................................3

4.0 REFERENCE DOCUMENT...........................................................................................................4

6.0 SYSTEM DESCRIPTION.............................................................................................................5

8.0 TRAINING REQUIREMENTS......................................................................................................6

9.0 TEST FUNCTIONS......................................................................................................................6

9.1 TEST FUNCTION NUMBER ONE: DOCUMENT AND DRAWING VERIFICATION.................6

9.2 TEST FUNCTION NUMBER TWO : MACHINE VERIFICATION...............................................8

9.3 TEST FUNCTION NUMBER THREE: LEVELLING VERIFICATION.........................................9

9.4 TEST FUNCTION NUMBE FOUR; MOC VERFICATION.........................................................10

9.5 TEST FUNCTION NUMBER FIVE: ELECTRICAL COMPONENT VERIFICATION.................11

9.6 TEST FUNCTION NUMBER SIX : LOCATION OF INSTALLATION VERIFICATION..........12

9.7 TEST FUNCTION NUMBER SEVEN: UTILILTIES VERIFICATION...........................................13

9.8 TEST FUNCTIN NUMBER EIGHT : CRITICAL INSTRUMENTS CALIBRATION REVIEW.......14

9.9 TEST FUNCTIN NUMBER NINE : OVERALL INSTALLATION VERIFICATION........................15

9.10 TEST FUNCTION NUMBER TEN: COMPONENT CERTIFICATION AND CALIBRATION......16

9.11 TEST FUNCION NUMBER ELEVEN : COMPONENT LIST VERIFICATION............................17

10.0 SAFETY REVIEW.......................................................................................................................27

11.0 DEVIATION HANDLING...........................................................................................................30

12.0 SUMMARY REPORT AND CONCLUSION..............................................................................31

AQUAKLENZ ROTARY AMPOULE WASHER

Code : SP-WA-01 Effective date : 25/12/2020 Page : 2/32

AQUAKLENZ ROTARY AMPOULE WASHER

Code : SP-WA-01 Effective date : 25/12/2020 Page : 3/32

3.0 IQ EXECUTION TEAM AND SIGNATURE VERIFICATION

Print name Designation Department/ Signature Date

Mr. Jai Prakash Maurya Acting head of Sterile SP/FA/LBS

AQUAKLENZ ROTARY AMPOULE WASHER

Code : SP-WA-01 Effective date : 25/12/2020 Page : 4/32

4.0 REFERENCE DOCUMENT

Following documents are referred during preparation of this protocol.

Document name Document number

Functions Responsible person Position

AQUAKLENZ ROTARY AMPOULE WASHER

Code : SP-WA-01 Effective date : 25/12/2020 Page : 5/32

6.0 SYSTEM DESCRIPTION

6.1 General description

6.2 Wash schematics

Sr No. Major components description

AQUAKLENZ ROTARY AMPOULE WASHER

Code : SP-WA-01 Effective date : 25/12/2020 Page : 6/32

8.0 TRAINING REQUIREMENTS

Identify the training need for Operating Personnel

9.0 TEST FUNCTIONS

9.1 TEST FUNCTION NUMBER ONE: DOCUMENT AND DRAWING VERIFICATION

AQUAKLENZ ROTARY AMPOULE WASHER

Code : SP-WA-01 Effective date : 25/12/2020 Page : 7/32

Sr. Title Doc’s No. revision date Present

1 GA Drawing of Ampoule washer DRG NO: KAW-20X4-MO1

2 Ampoule Washer (20x4) Assembly drawing 1 DRG NO: KAW-20X4-A01

3 Infeed / outfeed Assembly Drawing DRG NO: KAW-20X4-A02

4 Conveyor Assembly Drawing DRG NO: KAW-20X4-A03

5 Screw Assembly Drawing DRG NO: KAW-20X4-A04