L.B.S. LABORATORY L.P.

Operation Qualification Protocol

Equipment name : Protocol No. : Effective Date :

PyroKlenz Sterilizing and Depyrogenating OQ-K7 : QA-VC-003 04/12/2020
for Ampoules

Facility : Location : Revision :

L.B.S. LABORATORY L.P. Washing sterilization and 00
cooling auto (Room no.110)

Title :
OPERATION QUALIFICATION OF PYROKLENZ STERILIZING & DEPYROGENATING TUNNEL C-450

Approval of this Qualification Protocol is joint responsibility of the following functional area:

Name Designation Signature Date

Written by Mr.Natthaphon Malai Validation Officer

Reviewed by Ms.Saifone Harnchanaphol Validation coordinator

Reviewed by Mr.Panuwat Rungraksatham Head of Project Engineering

Reviewed by Mr.Jai PraKash Maurya Acting Head of sterile section

Approved by Mr.Wara Jivatadavirute QA Manager

 L.B.S. LABORATORY L.P.

Operational Qualification

STERILIZING AND DEPYROGENATING TUNNEL Protocol No. : OQ-K7 : QA-VC-003 Revision : 00

Code : SP-SR-01 Effective date : 04/12/2020 Page : 1/15

TABLE OF CONTENT

PAGE

1.0 OVERVIEW...................................................................................................................................2
2.0 SCOPE......................................................................................................................................... 2
3.0 EXECUTION TEAM AND OQ SIGNATURE VERIFICATION..................................................................2
4.0 REFERENCE DOCUMENTS.............................................................................................................3
5.0 RESPONSIBILITIES.......................................................................................................................3
6.0 SYSTEM DESCRIPTION..................................................................................................................4
7.0 DEFINITION AND ABBREVIATION.................................................................................................5
8.0 TRAINING REQUIREMENT..............................................................................................................5
9.0 TEST FUNCTIONS.........................................................................................................................6
9.1 TEST FUNCTION NUMBER ONE : TESTING EQUIPMENT CALIBRATION REVIEW.............................6
9.2 TEST FUNCTION NUMBER TWO : PROCEDURE LIST.....................................................................7
9.3 TEST FUNCTION NUMBER THREE : TRAINING RECORDS..............................................................8
9.4 TEST FUNCTION NUMBE FOUR : FUNCTIONAL VERIFICATION/ SEQUENCE OF OPERATION............9
9.5 TEST FUNCTION NUMBER FIVE : ALARMS , SAFETIES AND INTERLOCKS VERIFICATION..............11
10.0 SAFETY REVIEW......................................................................................................................13
11.0 OQ DEVIATION HANDLING LIST..............................................................................................13
12.0 SUMMARY REPORT AND CONCLUSION....................................................................................14
13.0 ABBREVIATIONS......................................................................................................................15
14.0 ATTACHMENT..........................................................................................................................15
 L.B.S. LABORATORY L.P.

Operational Qualification

STERILIZING AND DEPYROGENATING TUNNEL Protocol No. : OQ-K7 : QA-VC-003 Revision : 00

Code : SP-SR-01 Effective date : 04/12/2020 Page : 2/15

1.0 OVERVIEW
The sterilizing and depyrogenating tunnels C-450 with laminar air flow is used in aseptic manufacturing.
The tunnel contains three sections namely : preheating, heating and cooling. Sterilization and
depyrogenation occur at 300⁰C in the heating section. After sterilization and depyrogenation, cooling is
necessary before container filling. Therefore, It is important to keep the cooling section sterile by
maintaining a slight positive pressure towards the tunnel room.

2.0 SCOPE
2.0 To verify the operational attributes of the Sterilizing and Depyrogenating Tunnel
2.1 To establish documentary evidence to demonstrate that t h e Sterilizing and Depyrogenating tunnel
is qualified for correct operation as per design specification and GMP requirement.

3.0 EXECUTION TEAM AND OQ SIGNATURE VERIFICATION

Following personnel are involved in the execution of the Operation Qualification protocol. Each
personnel is identified by name, designation and signature in the following table.

Print name Designation Department / Signature Date

Company name
Mr. Natthaphon Malai Validation Officer VC / QA / LBS

Ms. Saifone Harnchanaphol Validation coordinator VC / QA /LBS

Mr. Panuwat Rungraksatham Head of Project Engineering MN / MN /LBS

Mr. Jai Prakash Maurya Acting Head of sterile section SP / FA / LBS

 L.B.S. LABORATORY L.P.

Operational Qualification

STERILIZING AND DEPYROGENATING TUNNEL Protocol No. : OQ-K7 : QA-VC-003 Revision : 00

Code : SP-SR-01 Effective date : 04/12/2020 Page : 3/15

4.0 REFERENCE DOCUMENTS

Following documents are referred during preparation of this document.

Document Name Document Number

Design Qualification KCC/C-450/DQ-0144
Installation Qualification KCC/C-450/IQ-0144
List of reference Drawings KT450-M01 to KT450-M16
Operation and Maintenance Manual No document number
FAT protocol KCC/C-450/FAT-0144
GA drawing for ampoule line KCCL-2546-02

5.0 RESPONSIBILITIES

Responsibilities of different department/ personnel involved in different activities related to the

operational qualification of the Sterilizing and Depyrogenating Tunnel are defined below :

Function Responsible person Position

Preparation of OQ document
Mr.Natthaphon Malai Validation officer
Review of OQ document
Ms.Saifone Harnchanaphol Validation coordinator
Review of OQ document
Mr.Panuwat Rungraksatham Head of Project engineer
Review of OQ document
Mr.Jai Prakash Maurya Acting Head of sterile section
Approval of OQ document
Mr.Wara Jivatadavirute QA Manager
Clearance of equipment for execution Mr.Panuwat Rungraksatham Head of Project engineer
Test functions verification Mr.Natthaphon Malai
Val Staff and Engineer
/ Mr.Panuwat Rungraksatham
Review of executed OQ document
Ms.Saifone Harnchanaphol Validation coordinator
Review of executed OQ document
Mr.Panuwat Rungraksatham Head of Project engineer
Review of executed of OQ document
Mr.Jai Prakash Maurya Acting Head of sterile section
Approval of executed OQ document Mr.Wara Jivatadavirute QA manager
 L.B.S. LABORATORY L.P.

Operational Qualification

STERILIZING AND DEPYROGENATING TUNNEL Protocol No. : OQ-K7 : QA-VC-003 Revision : 00

Code : SP-SR-01 Effective date : 04/12/2020 Page : 4/15

6.0 SYSTEM DESCRIPTION

6.1 General description
Description Specifications
Model C-450 (Ampoules)
Serial No. 012/04/0144
Overall dimensions-MM (L x W x H) 2925(L) x 1140(W) x 2500(H)
Drying zone 785(L) x 580(W) x 610(H)
Sterilizing zone 1000(L) x 880(W) x 1250(H)
Cooling zone 775(L) x 580(W) x 610(H)
Control panel dimension 1650(L) x 500(W) x 1850(H)
Electrical power supply 415V, 50Hz, 3 Phase (Flexible cable, 4 core x 25mm Square
with separate earthings)
Estimated Exhaust air Approx. 700 M3 /hr
Total weight (in Kgs)
Net weight 1400 Kgs
Gross weight 2000 Kgs
Working and Test condition
Ampoules capacity (ml) 1&2
Working height 900 ±20 mm
Control system All alarms are attended
Nominal output (1&2ml ampoule) 300 ampoules per minutes.
Belt width for carrying ampoules 450 mm

6.2 MAJOR COMPONENT

A. Drying Zone
B. Sterilizing zone
C. Cooling zone.
D. Exhaust duct
E. Exhaust HEPA filter
F. Chain Link Conveyor.
G. Machine drive
H. View Port
I. Gasket
 L.B.S. LABORATORY L.P.

Operational Qualification

STERILIZING AND DEPYROGENATING TUNNEL Protocol No. : OQ-K7 : QA-VC-003 Revision : 00

Code : SP-SR-01 Effective date : 04/12/2020 Page : 5/15

7.0 DEFINITION AND ABBREVIATION

1.1 Critical component : component which performance will have direct impact on the operation of the
system and /or the quality attributes of the processed materials. Critical components are calibrated or
certified using standards that are traceable to NIST Thailand.
1.2 Non-critical components : components which performance will have indirect or no impact on the steam
quality.
1.3 Deviation : Any event ( planned or unplanned ) that has the potential to adversely impact product
quality. Deviations may or may not have the potential to impact operations and operational costs.
1.4 Variance : Any event ( planned or unplanned) that has the potential to impact operations and
operational costs and no impact on product quality.

8.0 TRAINING REQUIREMENT

-
 L.B.S. LABORATORY L.P.

Operational Qualification

STERILIZING AND DEPYROGENATING TUNNEL Protocol No. : OQ-K7 : QA-VC-003 Revision : 00

Code : SP-SR-01 Effective date : 04/12/2020 Page : 6/15

9.0 TEST FUNCTIONS

9.1 TEST FUNCTION NUMBER ONE : TESTING EQUIPMENT CALIBRATION REVIEW

9.1.1 Objective :
To document the calibration status all test equipment.
9.1.2 Procedure :
1.1.1.1 Complete a list of all the equipment required for conducting OQ.
1.1.1.2 Verify that the test equipment is calibrated and the reference standards are
traceable to NIST Thailand or other accredited laboratories or institution.
1.1.1.3 Complete the Test Equipment List, indicating the equipment description, ID/serial number,
calibration date, re-calibration date.
9.1.3 Acceptance Criteria :
All equipment required for execution will be calibrated with copies of calibration records attached.

TESTING EQUIPMENT
Equipment Manufacturer Model Serial # Certified / Cal. date Next Cal. Initial
description calibrated due date /date

Comment : ……………………………………………………………………………………………………………………..….……..
………………………………………………………………………………………………………………………………………….………..
Meet Acceptance Criteria : ( ) Yes ( ) No.
Checked by ……………………………..……………..….. Date ………………………………………………..
Reviewed by ……………………………..…………………. Date ………………………………………………..
 L.B.S. LABORATORY L.P.

Operational Qualification

STERILIZING AND DEPYROGENATING TUNNEL Protocol No. : OQ-K7 : QA-VC-003 Revision : 00

Code : SP-SR-01 Effective date : 04/12/2020 Page : 7/15

9.2 TEST FUNCTION NUMBER TWO : PROCEDURE LIST

9.2.1 Objective :
To verify that the availability of the required procedure providing adequate direction and control over
the operation of the equipment.
9.2.2 Procedure :
1.1.1.1 Verify that the operation SOP provides personnel adequate direction and control over the
operation of the equipment.
1.1.1.2 Complete the procedure list.
9.2.3 Acceptance criteria :
All associated SOPs for operation and execution will be reviewed and documented.
PROCEDURE LIST
Sr. No. SOP No. Procedure Title

Comment : ……………………………………………………………………………………………………………………..….……..
………………………………………………………………………………………………………………………………………….………..
Meet Acceptance Criteria : ( ) Yes ( ) No.
Checked by ……………………………..……………..….. Date ………………………………………………..
Reviewed by ……………………………..…………………. Date ………………………………………………..
 L.B.S. LABORATORY L.P.

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Code : SP-SR-01 Effective date : 04/12/2020 Page : 8/15

9.3 TEST FUNCTION NUMBER THREE : TRAINING RECORDS

9.3.1 Objective :
To document the training of personnel for safe and proper operation of the system or equipment.
9.3.2 Procedure :
1.1.1.1 Document all personnel executing this protocol that have been trained on the SOP.
1.1.1.2 List all SOPs that must be used during the execution of this protocol.
1.1.1.3 Conduct training program for all listed SOP.
9.3.3 Acceptance criteria :
Operators are reasonably trained and training is documented.
Training Programs

Sr.No. SOP # Title Trainee Trainer

Comment : ……………………………………………………………………………………………………………………..….……..
………………………………………………………………………………………………………………………………………….………..
Meet Acceptance Criteria : ( ) Yes ( ) No.
Checked by ……………………………..……………..….. Date ………………………………………………..
Reviewed by ……………………………..…………………. Date ………………………………………………..
 L.B.S. LABORATORY L.P.

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STERILIZING AND DEPYROGENATING TUNNEL Protocol No. : OQ-K7 : QA-VC-003 Revision : 00

Code : SP-SR-01 Effective date : 04/12/2020 Page : 9/15

9.4 TEST FUNCTION NUMBE FOUR : FUNCTIONAL VERIFICATION/ SEQUENCE OF OPERATION

9.4.1 Objective :
To verify and document the operation and functionality of the equipment.
9.4.2 Procedure :
1.1.1.1 Test the functionalities and operation attributes of the equipment with procedures supplied by
manufacturer.
1.1.1.2 Indicate “Yes” if the result were as expected and “No” if the expected result did not happen.
1.1.1.3 Document any discrepancies in the Deviation Reporting Log. If any variances /deviations are
present, complete the appropriate deviation /variance form.
9.4.3 Acceptance criteria :
All functional requirements must conform to the expected responses.

A. Power Continuity Check :

Objective : To ensure that power is available to the Control Panel
Procedure :
1. Check fuses using the continuity tester, record that all fuses have been checked in the table
below.
2. Replace all MCBs in the correct position, check circuit breakers are in the ON position.
3. Ensure that power supply to the machine is available.
4. Check earth continuity.
Acceptance Criteria :
MCB’s not damaged and rated as per electrical diagrams

MCB Tag no. Rating

Comment : ……………………………………………………………………………………………………………………..….……..
………………………………………………………………………………………………………………………………………….………..
Meet Acceptance Criteria : ( ) Yes ( ) No.
Checked by ……………………………..……………..….. Date ………………………………………………..
Reviewed by ……………………………..…………………. Date ………………………………………………..
 L.B.S. LABORATORY L.P.

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B. Product Out Put Verification

Objective : To carry out plant running trial for observing performance of the Sterilizing and
Depyrogenating Tunnel

Procedure : Perform the operation as indicated in form.

Acceptance Criteria
All acceptance criteria in the list must be met.

Sr. Ampoule Dia Height Ampoule Output Ampule output Conforms

No. Size (mm) (mm) (APM specified ) (Actual)
(ml)
YES NO
YES NO
YES NO

Comment : ……………………………………………………………………………………………………………………..….……..
………………………………………………………………………………………………………………………………………….………..
Meet Acceptance Criteria : ( ) Yes ( ) No.
Checked by ……………………………..……………..….. Date ………………………………………………..
Reviewed by ……………………………..…………………. Date ………………………………………………..
 L.B.S. LABORATORY L.P.

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STERILIZING AND DEPYROGENATING TUNNEL Protocol No. : OQ-K7 : QA-VC-003 Revision : 00

Code : SP-SR-01 Effective date : 04/12/2020 Page : 11/15

9.5 TEST FUNCTION NUMBER FIVE : ALARMS , SAFETIES AND INTERLOCKS VERIFICATION

9.5.1 Objective :
To verify and document the alarms, safeties and interlocks of the equipment.
9.5.2 Procedure :
 Follow the test procedures provided by the manufacturer.
 Observe the operations and verify the result by checking “Pass” or “Fail”.
 Indicate “Pass” if the results are as expected and “Fail” if the expected result does not happen.
 Document any discrepancies in the Deviation Report Log. If any variances /deviations are present,
complete the appropriate deviation/variance form.
9.5.3 Acceptance criteria :
All safeties and interlock requirements must conform to the expected responses.
Alarms Reaction Verified
Tunnel Inadequate Ampoule Conveyor stop Pass Fail
(Auto Reset)
Tunnel Outfeed O/L (Auto reset) Conveyor stop Pass Fail
Heater Safety Microswitches Operated (Auto reset) Heater + Conveyor stop Pass Fail
Filter Safety Controller ON (Auto reset) Heater + Conveyor stop Pass Fail
Vapor Exhaust Blower O/L (Ack) Conveyor & Vapor Exhaust Blower stop Pass Fail
Exhaust Blower1 O/L (Ack) Conveyor& Exhaust Blower1 stop Pass Fail
Exhaust Blower 2 O/L (Ack) Conveyor& Exhaust Blower 2 stop Pass Fail
Auto Pressure Blower O/L (Ack) Conveyor +Auto Pressure stop Pass Fail
Conveyor Motors O/L (Ack) Conveyor Motor Stop Pass Fail
DZ VFD O/L (Ack) DZ Blower + Conveyor Stop Pass Fail
CZ VFD O/L (Ack) CZ Blowers + Conveyor Stop Pass Fail
HZ Entry Damper Motor O/L (Ack) HZ Entry Damper + Conveyor stop Pass Fail
HZ Exit Damper Motor O/L (Ack) HZ Exit Damper + Conveyor stop Pass Fail
CZ Exit Damper Motor O/L (Ack) CZ Exit Damper + Conveyor Stop Pass Fail
CZ Cut-off Temp. (Auto Reset) Conveyor + Printing Pass Fail
Heater Bank 1 Phase Fail (Ack) Only display Pass Fail
Heater Bank 2 Phase Fail (Ack) Only display Pass Fail
Heater Bank 3 Phase Fail (Ack) Only display Pass Fail
Heater Bank 4 Phase Fail (Ack) Only display Pass Fail
Drying Zone (PT-100) Fail Conveyor stop Pass Fail
Hot Zone In (Pt-100) Fail Conveyor + Heater Stop Pass Fail
Hot zone Out (PT-100) Fail Conveyor + Heater Stop Pass Fail
Cooling zone (Pt-100) Fail Conveyor stop Pass Fail
Stabilizing zone (Pt-100) Fail Conveyor stop Pass Fail
Δ P DZ Low/High Conveyor stop Pass Fail
Δ P HZ low/high Conveyor stop Pass Fail
Δ P CZ low/high Conveyor stop Pass Fail
Δ P Washing to Filling Low/High Conveyor stop Pass Fail
Emergency pressed Tunnel stop Pass Fail
Inadequate/ Toppled Vial Machine stop Pass Fail
Washer Outfeed O/L Machine stop Pass Fail
Process Air Set Pressure Low Machine stop Pass Fail
 L.B.S. LABORATORY L.P.

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Alarms Reaction Verified

WFI Water Set Pressure Low Machine stop Pass Fail
Recirculatory Water Set Pressure Low M/C + turntable motor stop Pass Fail
Turn table Motor O/L M/C + Main Drive motor stop Pass Fail
Main Drive motor O/L M/C + Main Drive motor stop Pass Fail
Aspirator Motor O/L M/C + Aspirator Motor Stop Pass Fail
Recirculatory Water Temp. Low M/C + RCW Pump Stop Pass Fail
Recirculatory Water Pump O/L M/C + RCW Pump Stop Pass Fail
Recirculatory Water Low RCW Pump + M/C Stop Pass Fail
Emergency Pressed Washer Stop Pass Fail
Power failure Only heater stop Pass Fail
UPS failure All process will stop Pass Fail
UPS ON PLC remains ON, data are saved for Pass Fail
record and retrieval

Comment : ……………………………………………………………………………………………………………………..….……..
………………………………………………………………………………………………………………………………………….………..
Acceptance Criteria : Alarm sound with corresponding HMI display if causative event taking place.
Meet Acceptance Criteria : ( ) Yes ( ) No.
Checked by ……………………………..……………..….. Date ………………………………………………..
Reviewed by ……………………………..…………………. Date ………………………………………………..
 L.B.S. LABORATORY L.P.

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10.0 SAFETY REVIEW

-

11.0 OQ DEVIATION HANDLING LIST

11.1 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.
11.2 Procedure
1.1.1 Document all deviations found during execution using the Deviation Report Form that is with the
Deviation Report Log.
1.1.2 In case of deviation follow SOP no. QA-QI-008.
1.1.3 Complete Deviation Report Forms are submitted to QA for signature acceptance.

Sr. Deviation Evaluation / Action Assigned Verified Action Approved

No. Corrective shall be Date for by Completed By
Action taken by Completion
 L.B.S. LABORATORY L.P.

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12.0 SUMMARY REPORT AND CONCLUSION

Summary report :

The following test function were checked during execution this protocol.

Meets Acceptance Criteria

Test function#1: Test Equipment and Calibration Review  YES  NO

Test function#2: Procedure list  YES  NO
Test function#3: Training and records  YES  NO
Test function#4: Function verification and sequence of operation  YES  NO
Test function#5: Alarms, safety and interlocks  YES  NO

Conclusion :

 1. Machine conforms with the requirements of operation and it is released for next step of Qualification.

 2. Machine does not conform with the requirements of the operation and it is not released for next step of
Qualification until all deviations are attended and certified.

Written by ……………………….………………………… Date ……………………………………………………

Reviewed by …………………………………………..……… Date ……………………………………………………

 L.B.S. LABORATORY L.P.

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13.0 ABBREVIATIONS
URS User requirement Specifications
CA Approximately
APM Ampoules per minute
cGMP current Good Manufacturing Practice
LAF Laminar Air Flow
AISI American Iron Steel Institute
MOC Material of construction
MS Mild Steel
SS Stainless steel
HEPA High Efficient Particulate Air
PLC Programmable Logic Controller
HMI Human Machine Interface
P&ID Piping & Instrumentation Diagram
DQ Design Qualification
IQ Installation Qualification
OQ Operation Qualification
FAT Factory Acceptance Test

14.0 ATTACHMENT

Attachment no Description