10072-02 RQ Protocol Line-1 Tunnel-001

TITLE REFERENCE SOP Protocol No.
:10072-02
: :
RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Details of Equipment/ System Production PN/TUNNL-001 Vial washing area Line-1 / PN025 IMA-LIBRA / BLUE GALAXY 870 FLS LD 8015
User Department System ID Equip. Location/ Room No. Equip. Make/ Model Equip. Serial No. (Supplier) Document Effective Date Qualification Start Date Qualification Completion Date Requalification due date
Table of Contents S. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. Details Pre-Approval Scope Objective Abbreviations Responsibility Intended use of equipment Equipment / system description Safety Precautions Training Record Equipments/ Materials Required for Qualification Verification of calibration status Verification of operational controls Qualification requirements & observations Qualification Tests & Results Requalification criteria Details of Discrepancies Summary / Conclusion References Annexure Post Approval Page No. 02 03 03 03 04 04 04 05 05 06 07 08 08 28 30 30 31 32 32 33
1. PRE APPROVAL: Page 1 of 34
Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot Nos - 4, 34 to 48, EPIP, IP-Pashamylaram, Medak(Dist.), Hyderabad 502307
TITLE REFERENCE SOP Protocol No.:10072-02 Name Prepared by
: :
RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Designation Department Signature /date
Reviewed by
Approved by
2. SCOPE: Page 2 of 34
TITLE REFERENCE SOP Protocol No.:10072-02
: :
RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001
This qualification protocol is applicable for the requalification of depyrogenation tunnel in vial washing room of manufacturing Line-1 as per the Qualification Plan 20017. 3. OBJECTIVE: The objective of this protocol is to ensure the consistency, repeatability and reproducibility of the depyrogenation tunnel machine in the following conditions. Measurement of airflow velocity Verification of Differential pressures across zones. Installed filter system integrity / Leakage test. Air flow pattern test. Non-viable particle count. Verification of Conveyor Speed. Heat Penetration Study with biological qualification. Heat Penetration Study with biological qualification by increasing set speed. Physical observation of vials during qualification run. 4. ABBREVIATIONS: ID No. MOC NA OQ PQ QA QC RQ S. No. PN AISI Identification Number Material of Construction Not Applicable Operational Qualification Performance Qualification Quality Assurance Quality Control Re-Qualification Serial Number Production American Iron And Steel Institute
Page 3 of 34
TITLE REFERENCE SOP Protocol No.:10072-02 5. RESPONSIBILITY: Department/ Function Validation group Engineering / Instrumentation Quality Control User department Quality Assurance
: :
Responsibility Preparation & Execution of the protocol and collection of samples. Review the activity and provide required technical support. To perform testing of samples, wherever applicable. To provide necessary support For the execution of activity To review and approve the executed protocol with supporting data
6. INTENDED USE OF EQUIPMENT Depyrogenation tunnel is used for the preparation/processing (depyrogenation) of containers for the filling of sterile drug product. Depyrogenation process shall be done by using filtered dry hot air. 7. EQUIPMENT/ SYSTEM DESCRIPTION Depyrogenating Tunnel is located at Vial washing room Line-1 of Ground Floor Production Department. The purpose of Depyrogenating Tunnel is to depyrogenate the Vials coming out from the Vial washing Machine. The tunnel, constructed in AISI 304, consists of three laminar flow zones such as inlet zone, heating zone and cooling zone. The clean and slighty containers are arranged and automatically deposited by the washer on to the tunnel conveyor belt at the in-feed zone. The tunnel inlet zone is protected by sterile laminar air flow which protects the washed vials discharged by washing machine and prevents any hot, saturated air, released from the heating zone because of higher pressure. The vials coming out from the heating zone enter into the cooling zone where they struck by the cooling laminar flow and brought to temperature required for the successive working. With the principle of communicating vessel, assisted by the make up of the hot zone tunnel permits operation with difference in pressure between the sterile chamber and the tunnel area Page 4 of 34
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of 50 Pascal with variation of 15 of such value are absorbed and balanced automatically with out altering the operating parameters. The tunnel sterilizer equipped with anemometer, DP meters, hot zone air flow measurement system and Automatic adjustment of air speed basing on the density. 8. SAFETY PRECAUTIONS: Personnel involved in autoclave qualification shall follow proper written procedures for equipment operation. Personnel shall wear necessary gloves, wherever applicable. Do not touch the hot surfaces during validation. Care should be taken while handling with electrical cables.
9. TRAINING RECORD: Purpose To train all the personnel involved in execution of qualification, on following attributes: System Description Protocol, applicable SOPs and documentation.
Doc. Ref. No(s). Training by S. No. Name of the participant Area of Operation Sign and Date
Trainer (Sign and Date):
Page 5 of 34
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10. INSTRUMENT/ MATERIALS REQUIRED FOR QUALIFICATION: 10.1 S. No. 1 2 3 4 5 6 7 8 9 10 11 13 Data logger Smoke generator Stop watch Sensor details S. Instrument Name No. 1 Temperature mapping probes Checked By: (Sign and Date) Pre calibration date Reviewed By: (Sign and Date) Post calibration date Non-Viable particle counter Details of Instruments Instrument Name Anemometer Digital manometer Aerosol Photometer Instrument ID IN/ANMTR-001 IN/ANMTR-002 IN/DMNMR-001 IN/APHMR-001 PN/PLCTR-001 PN/PLCTR-003 PN/PLCTR-004 PN/PLCTR-005 PN/PLCTR-006 Calibration certificate No./ Done date Calibration Due date
Page 6 of 34
TITLE REFERENCE SOP Protocol No.:10072-02 10.2
: :
Details of materials Endotoxin spiked container Specific size & quantity of the container as per requirement Minicolt-4 smoke refill canister / Dry Ice PAO
11. VERIFICATION OF CALIBRATION STATUS: Equipment Name Instrument Name Instrument ID No. PN/TUNNL-001-MG001 PN/TUNNL-001-MG002 Magnehelic Gauge PN/TUNNL-001-MG003 PN/TUNNL-001-MG004 PN/TUNNL-001-MG005 PN/TUNNL-001-MG006 DP Transmitter Tunnel Temperature Sensor PN/TUNNL-001-DPT001 PN/TUNNL-001-DPT002 PN/TUNNL-001-TS001 PN/TUNNL-001-TS002 PN/TUNNL-001-TS003 PN/TUNNL-001-TS004 Strip chart Recorder Anemometer Remarks: Checked By: (Sign and Date) Reviewed By: (Sign and Date) PN/TUNNL-001-SC001 PN/TUNNL-001-AM001 PN/TUNNL-001-AM002 PN/TUNNL-001-AM003 Calibration Date Calibration Due Date
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12. VERIFICATION OF OPERATIONAL CONTROLS: Description of Control Availability of approved operation, cleaning and monitoring SOPs 2 Availability of approved PM SOP 3 Availability of log books for recording the activities 4 Implementation of gowning practices with SOPs Remarks: Checked By: (Sign and Date) S. No. 1 Document Ref. No. Status/ Remarks
Reviewed By: (Sign and Date)
13. QUALIFICATION REQUIREMENTS & OBSERVATIONS: 13.1 Measurement of airflow velocity: Switch on the tunnel fans in maintenance mode. The tunnel should be stabilized at least 15 min prior to start the activity and heaters should be OFF. Perform the air velocity measurement test as per SOP # FU4-QA-GEN-040 and record the observations. Calculate minimum, maximum & average velocity of all locations.
13.1.1 Procedure
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Diagram.1 HEPA Filter location drawing
1 5 4
Diagram.2 Air velocity sampling locations of filter
13.1.2 Acceptance criteria: Air velocity should be with 79-118 FPM (0.4-0.6 m/s) at conveyer level in infeed zone, hot zone and cool zone.
Page 9 of 34
TITLE REFERENCE SOP Protocol No.:10072-02 13.1.3 Result:
: :
PERFORMANCE/ RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001
Page 10 of 34
TITLE REFERENCE SOP Protocol No.:10072-02 Name of the instrument used: Instrument Id: Filter No Filter-1 Filter-2 Filter-3 Filter-4 Filter-5 Filter-6 Filter-7 Remarks: Done by : (Sign/Date) 13.2 L1 L2
: :
RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Calibration due Date: Calibration certificate no: Grill Location & Velocity in m/s L4 L5 Acc. limit
L3
Min
0.4-0.6 m/s
Checked By: (Sign/Date) Verification of Differential pressures across zones:
Reviewed By: (Sign/Date)
13.2.1 Procedure : Monitor & record the pressure differential values from the calibrated magnehelic gauge across zones. Perform the differential pressure test as per SOP # FU4-QA-GEN-040 and record the observations for the various zones using manometer. While measuring DP between zone to zone and zone to room, place manometer positive end in high pressure zone and negative in low pressure zone.
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Diagram .3 Differential pressure representations
13.2.2 Acceptance criteria & Results Description Filter-1 (Across filter) Filter-2 (Across filter) Filter-3 (Across filter) Filter-4 (Across filter) 120 pa -400 pa. Acceptance criteria 120 pa -350 pa. Observation Result Pass/Fail Pass/Fail Pass/Fail Pass/Fail Remarks
Page 12 of 34
TITLE REFERENCE SOP Protocol No.:10072-02 Filter-5 (Across filter) Filter-6 (Across filter) Filter-7 (Across filter) DP between Infeed zone and washing room DP between Depyrogenation zone and Infeed zone DP between depyrogenation zone and cool zone DP between filling room and cool zone Done by: (Sign/Date)
: :
RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Pass/Fail Pass/Fail 120 pa -350 pa. Infeed zone DP should be higher than washing room Depyrogenation zone DP should be higher than Infeed zone Depyrogenation zone DP should be higher than cool zone Filling room DP should be higher than cool zone Checked By: (Sign/Date) Pass/Fail Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail Reviewed By: (Sign/Date)
Note: whichever is correct in result column.
13.3 Installed filter system integrity / Leakage test: 13.3.1 Test Procedure: Perform the filter integrity test as per SOP # FU4-QA-GEN-040 and record the observations. The downstream concentration of aerosol from each HEPA filter should not be more than 0.01%, while upstream PAO concentration is set as 100%.
13.3.2 Acceptance criteria:
13.3.3 Results: Page 13 of 34
TITLE REFERENCE SOP Protocol No.:10072-02 Filter ID No. Filter-1 Filter-2 Filter-3 Filter-4 Filter-5 Filter-6 Filter-7 Remarks if any: Checked by : (Sign / Date)
: :
RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Mounting joints % Result Pass/Fail Pass/Fail Pass/Fail Pass/Fail Pass/Fail Pass/Fail Pass/Fail Done By Sign/Date:
Upstream Downstream Concentration % Concentration %
Reviewed by: (Sign / Date)
Note: whichever is correct in result column. 13.4 Air flow pattern test: 13.4.1 Procedure: Ensure that the tunnel air velocities and pressure differential are maintained. Perform the air flow pattern test as per SOP # FU4-QA-GEN-040 and record the observations. Attach the air flow pattern visual record to the executed protocol.
13.4.2 Acceptance criteria & Results
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RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Acceptance criteria The air flow should be from Infeed zone to washing room The air flow should be towards Infeed zone and cool zone The airflow should be towards cooling zone Laminarity should be observe until Working height level. Laminarity should be observe until Working height level. Observation Complies / Not complies Complies / Not complies Complies / Not complies Complies / Not complies Complies / Not complies
Description of test Generate the fog near Infeed zone towards panels Generate the fog in Depyrogenation zone Generate the fog in Filling room near turn table panel Generate the fog near filters in Infeed zone Generate the fog near filters in cooling zone Remarks: Checked by : (Sign / Date)
Reviewed by: (Sign / Date)
Note: whichever is correct in result column. 13.5 Non-viable particle count 13.5.1 Procedure: A discrete particle counting, light scattering instrument is used to determine the concentration of air borne particles, equal to and larger than the specified sizes, at designated sampling locations. Perform the non viable particle count test as per SOP # FU4-QA-GEN-040 and attach the non viable particle count data printout to the executed protocol. All the readings of test should pass the below mentioned criteria. Maximum permitted number of particles/m3 is mentioned in following table. At rest Maximum permitted number of particles/m3 0.5m/ m3 5m/ m3 3520 20 Page 15 of 34
13.5.2 Acceptance criteria:
: :
Diagram.5 NVPC location drawing 13.5.3 Results; Location Infeed zone location-1 Infeed zone location-2 Infeed zone location-3 Depyrogenation zone location-1 Depyrogenation zone location-2 Depyrogenation zone location-3 Cool zone location-1 Cool zone location-2 Cool zone location-3 Done by Sign/Date Checked By : (Sign/Date) 13.6 Verification of conveyor speed : 13.6.1 Procedure: Perform the conveyor speed verification for all the set speeds. During qualification verification of conveyor speed shall be done as per SOP # FU4-QAGEN-040. Operate the tunnel as per SOP # FU4-PR-MF-OPI-002 Observation 0.5m / m
3
Results 5m / m
3
Reviewed By : (Sign/Date)
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13.6.2 Acceptance criteria: Conveyor speed should be within 5% of set speed 13.6.3 Results: S. No. Container size Set Conveyor Speed Observed conveyor Speed Results Done by Sign / Date
Remarks if any: Checked By: (Sign/Date ) Reviewed By: (Sign/Date)
13.7 Heat Penetration Study with Endotoxin Spiked Vials 13.7.1 Procedure Heat penetration study with endotoxin spiked containers shall be performed for following containers 2 mL vial with 13 mm neck 3 mL vial with 13 mm neck 5 mL vial with 20 mm neck 10 mL vial with 20 mm neck 20 mL vial with 20 mm neck 30mL vial with 20 mm neck Page 17 of 34
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The tunnel when operated with fully loaded glass vials on the conveyor is capable of producing the temperature profiles in side the vials distributed across the conveyor belt as per the temperature set points set in the PLC of the equipment. Operate the tunnel as per SOP # FU4-PR-MF-OPI-002 & perform the heat penetration study as per SOP # FU4-QA-GEN-040. The placement of spiked Endotoxin vials and temperature sensors in empty vial are depicted in the below diagram. Note: The tunnel conveyor should not stop when SS zigs are in depyrogenation zone Left side conveyor edge Depyrogenation zone
In feed zone
Cool zone
Right side conveyor edge Vial with temperature sensor 13.7.2 Acceptance criteria: Each temperature sensor of the row should be more than 300C for minimum of 3 minutes (Considered as residence time) during Depyrogenation period of each run. The temperature variation across all sensors in any row shall not be more than 20C at any stage in passage of load during calculated residence time. Depyrogenation zone temperature during Depyrogenation period shall be at 330 6C and the same shall be confirmed through strip chart to ensure the equipment functionality. Minimum 3- log reduction should be achieved for endotoxin spiked vials. Endotoxin Spiked Vial
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TITLE REFERENCE SOP Protocol No.:10072-02 13.7.3 Results:
: :
Parameters Container details vial size Neck Size 2 mL 13 mm 3mL 13 mm
Observations 5 mL 10 mL 20 mm 20 mm
20 mL 20 mm
30 mL 20 mm
Results
Date of cycle Cycle Start Time Cycle End Time Set conveyor speed Observed conveyor speed (max) Depyrogenation hold start time for set -1 Depyrogenation hold end time for set-1 Calculated residence time for set-1 Depyrogenation hold start time for set -2 Depyrogenation hold end time for set-2 Calculated residence time for set-2 Depyrogenation hold start time for set -3 Page 20 of 34
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RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Observations 5 mL 10 mL 20 mm 20 mm
Parameters vial size Neck Size Depyrogenation hold end time for set-3 Calculated residence time for set-3 Minimum temperature during depyrogenation hold period for set-1 Maximum temperature during depyrogenation hold period for set-1 Maximum temperature variation across the probes in any row during Depyrogenation hold period for set-1 Minimum temperature during depyrogenation hold period for set-2 Maximum temperature during depyrogenation hold period for set-2 Maximum temperature variation across the probes in any row during Depyrogenation hold period for set-2 Minimum temperature during Container details 2 mL 13 mm 3mL 13 mm
20 mL 20 mm
30 mL 20 mm
Results
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RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Observations 5 mL 10 mL 20 mm 20 mm
Parameters vial size Neck Size depyrogenation hold period for set-3 Maximum temperature during depyrogenation hold period for set-3 Maximum temperature variation across the probes in any row during Depyrogenation hold period for set-3 Maximum variation ( C) of temperature from set point (330C) in strip chart Done by sign/Date Container details Remarks if any: Checked by : (Sign/Date) Reviewed by : (Sign/Date) 2 mL 13 mm 3mL 13 mm
20 mL 20 mm
30 mL 20 mm
Results
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13.8 Heat Penetration Study with Endotoxin Spiked Vials with increased set speed 13.8.1 Procedure: Perform the one heat penetration run with endotoxin spiked vials by increasing 5% of set speed and followed same procedure as mentioned in 13.7.1. Each temperature sensor of the row should be more than 300C for minimum of 3 minutes (considered as residence time) during Depyrogenation period of each run. The temperature variation across all sensors in any row shall not be more than 20C at any stage in passage of load during calculated residence time. Depyrogenation zone temperature during Depyrogenation period shall be at 330 6C and the same shall be confirmed through strip chart to ensure the equipment functionality. Minimum 3- log reduction should be achieved for endotoxin spiked vials.
13.8.2 Acceptance criteria :
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TITLE REFERENCE SOP Protocol No.:10072-02 13.8.3 Result:
: :
Parameters Container details Date of cycle Cycle Start Time Cycle End Time Actual conveyor speed Increased set conveyor speed Observed conveyor speed (max) Depyrogenation hold start time for set -1 Depyrogenation hold end time for set-1 vial size Neck Size 2 mL 13 mm
Observations 3mL 13 mm 5 mL 20 mm 10 mL 20 mm 20 mL 20 mm 30 mL 20 mm Results
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RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Observations vial size Neck Size 2 mL 13 mm 3mL 13 mm 5 mL 20 mm 10 mL 20 mm 20 mL 20 mm 30 mL 20 mm Results
Parameters Container details
Calculated residence time for set-1 Depyrogenation hold start time for set -2 Depyrogenation hold end time for set-2 Calculated residence time for set-2 Depyrogenation hold start time for set -3 Depyrogenation hold end time for set-3 Calculated residence time for set-3 Minimum temperature during depyrogenation hold period for set-1 Maximum temperature during depyrogenation hold period for set-1 Page 25 of 34
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RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Observations vial size 2 mL 13 mm 3mL 13 mm 5 mL 20 mm 10 mL 20 mm 20 mL 20 mm 30 mL 20 mm Results
Parameters Neck Size Maximum temperature variation across the probes in any row during Depyrogenation hold period for set-1 Minimum temperature during depyrogenation hold period for set-2 Maximum temperature during depyrogenation hold period for set-2 Maximum temperature variation across the probes in any row during Depyrogenation hold period for set-2 Minimum temperature during depyrogenation hold period for set-3 Maximum temperature during depyrogenation hold period for set-3 Maximum temperature variation across the probes in any row during Depyrogenation hold period for set-3 Container details
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RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Observations vial size 2 mL 13 mm 3mL 13 mm 5 mL 20 mm 10 mL 20 mm 20 mL 20 mm 30 mL 20 mm Results
Parameters Neck Size Maximum variation ( C) of temperature from set point (330C) in strip chart Done by sign/Date Remarks if any: Checked by : (Sign/Date) Container details
Reviewed by : (Sign/Date)
Note-1: If 1 probe gets opened during depyrogenation consider remaining 11 sensors data. At least 11 sensors should be functional throughout the cycle to consider it satisfactorily.
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13.9 Physical observation of vials during heat penetration study: 13.9.1 Procedure: Physical observation of the containers shall be done by viewing through the glass window of the tunnel (cool zone) for following parameters. Movement of the vial, tilting of vial on conveyor, breakage of the vial, charring of the vial.
13.9.2 Acceptance criteria & Results: Parameters / S.No. Acceptance criteria Vial should move on the conveyor belt in 1 erect condition. No vial should be tilted No breakage of vials 2 should be observed No charring spot should be observed 3 on the surface of the vials Observed by sign 4 /date Remarks if any: Checked by Sign/Date : Observation 2 mL 3mL 5mL 10mL 20mL 30mL
Reviewed by Sign/Date :
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14 QUALIFICATION TESTS & RESULTS: Refere nce Docum ent No. SOP # FU4QA-GEN-040 SOP # FU4QA-GEN-040 SOP # FU4QA-GEN-040 SOP # FU4QA-GEN-040 SOP # FU4QA-GEN-040 SOP # FU4QA-GEN-040 SOP # FU4Page 29 of 34
S. No.
Test
Item/ Stage
Acceptance Criteria
Results
Si gn & D at e
Measurement of Air flow velocity Differential pressure test Filter integrity / Leakage test Air flow pattern test Non viable particle Verification of conveyor speed Heat penetration study
Refer point no.13.1.2 Refer point no.13.2.2 Refer point no.13.3.2 Refer point no.13.4.2 Refer point no.13.5.2 Refer point no.13.6.2 Refer point no.13.7.2
: :
RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Si gn & D at e
S. No.
Test
Item/ Stage
Refere nce Docum ent No. QA-GEN-040 NA SOP # FU4QA-GEN-040
Acceptance Criteria
Results
with Endotoxin spiked vials Heat penetration study with Endotoxin spiked vials with increased set speed Physical observation of vials during Heat penetration study
Refer point no.13.8.2
Refer point no.13.9.2
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15 REQUALIFICATION CRITERIA 15.1 Scheduled re-qualification: Heat Penetration and Endotoxin challenge trials shall be done as part of a time-related requalification programme for every tunnel. Re-qualification shall be performed once in six months at minimum. One heat penetration with endotoxin challenge trail shall be done on every process specification / container size combination on each tunnel at least once per 2-years. Where HEPA filter in situ integrity testing in the hot zone of LAF tunnels is required to be done twice per year at approximately 6 month intervals.
15.2 Unscheduled re-qualification: Any modification in the depyrogenation process parameters or any major maintenance of equipment which has impact on depyrogenation, shall be properly investigated. Based on out come of the investigation results requalification shall be performed. Introduction of any new container (specifications/source) shall be qualified, based on the impact assessment on the depyrogenation efficiency.
16 DETAILS OF DISCREPANCIES: Description Notification Ref. No. Proposed/ Performed Corrective Actions Recorded By (Sign and Date)
Impact on Qualification/ Further Actions to be taken (if any):
Reviewed By (User): (Sign and Date)
Approved By (QA): (Sign and Date)
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17 SUMMARY/ CONCLUSION:
Prepared by: Sign/Date : Page 32 of 34
Reviewed by: Sign/Date :
: :
18 REFERENCES: SOP # FU4-QA-GEN-040 - Qualification/ Re-Qualification of Depyrogenation Tunnel SOP # FU4-PR-MF-OPI-002 - Cleaning and Operation of Depyrogenating Tunnel (MakeIMA). SOP # FU4-EN-OPI-007- Operation of digital temperature data logger. SOP # FU4-QC-MIC-GEN-029 - Handling and Maintenance of Endotoxin Indicators
19 ANNEXURES: S. No. Title/ Description of Annexure No. of Pages
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20 POST APPROVAL: Name Executed by Designation Department Signature/ Date
Reviewed by
Approved by
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10072-02 RQ Protocol Line-1 Tunnel-001

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TITLE REFERENCE SOP Protocol No.

1. PRE APPROVAL: Page 1 of 34

TITLE REFERENCE SOP Protocol No.:10072-02 Name Prepared by

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

Trainer (Sign and Date):

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

TITLE REFERENCE SOP Protocol No.:10072-02 10.2

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

Reviewed By: (Sign and Date)

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

Diagram.1 HEPA Filter location drawing

Diagram.2 Air velocity sampling locations of filter

TITLE REFERENCE SOP Protocol No.:10072-02 13.1.3 Result:

PERFORMANCE/ RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

Checked By: (Sign/Date) Verification of Differential pressures across zones:

Reviewed By: (Sign/Date)

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

Diagram .3 Differential pressure representations

Pass/Fail Reviewed By: (Sign/Date)

Note: whichever is correct in result column.

13.3.2 Acceptance criteria:

13.3.3 Results: Page 13 of 34

Upstream Downstream Concentration % Concentration %

Reviewed by: (Sign / Date)

13.4.2 Acceptance criteria & Results

TITLE REFERENCE SOP Protocol No.:10072-02

Reviewed by: (Sign / Date)

13.5.2 Acceptance criteria:

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

Remarks if any: Checked By: (Sign/Date ) Reviewed By: (Sign/Date)

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

TITLE REFERENCE SOP Protocol No.:10072-02 13.7.3 Results:

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

Parameters Container details vial size Neck Size 2 mL 13 mm 3mL 13 mm

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Observations 5 mL 10 mL 20 mm 20 mm

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001 Observations 5 mL 10 mL 20 mm 20 mm

TITLE REFERENCE SOP Protocol No.:10072-02

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

13.8.2 Acceptance criteria :

TITLE REFERENCE SOP Protocol No.:10072-02 13.8.3 Result:

RE QUALIFICATION PROTOCOL FU4-QA-GEN-035/ FU4-QA-FORM-120-1 Equipment No.: PN/TUNNL-001

Observations 3mL 13 mm 5 mL 20 mm 10 mL 20 mm 20 mL 20 mm 30 mL 20 mm Results

TITLE REFERENCE SOP Protocol No.:10072-02

Parameters Container details

TITLE REFERENCE SOP Protocol No.:10072-02

TITLE REFERENCE SOP Protocol No.:10072-02