PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT FOR
DEPYROGENATING & STERILIZING TUNNEL
Protocol cum Report No.: Batch Size: 250 vials Page No.: 1 of 25
PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
PERFORMANCE QUALIFICATION
PROTOCOL CUM REPORT FOR
DEPYROGENATING AND
STERILIZING TUNNEL
PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT FOR
DEPYROGENATING & STERILIZING TUNNEL
Protocol cum Report No.: Batch Size: 250 vials Page No.: 2 of 25
PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
CONTENTS
S. No. Description
1.0 Approval of Performance Qualification Protocol
2.0 Objective
3.0 Responsibilities
4.0 Equipment Description & Identification
5.0 Methodology for Performance Qualification
6.0 Critical parameters and acceptance Criteria
7.0 Verification of reference documents
8.0 Verification of Materials Required
9.0 Training Records
10.0 Test Equipment Details
11.0 Depyrogentaing and Sterilizing Tunnel Set Parameters
12.0 Records of Observations and Results
13.0 Deviation Sheet
14.0 List of Appendix
15.0 Summary & Conclusion
16.0 Post Approval of Performance Qualification
Appendix 1: Deviation and Corrective Action Report Form
PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT FOR
DEPYROGENATING & STERILIZING TUNNEL
Protocol cum Report No.: Batch Size: 250 vials Page No.: 3 of 25
PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
1.0 Protocol cum Report approval
Protocol Prepared BY:
Functional Area Name Signature Date
Production
Engineering
Quality Assurance
Protocol Reviewed By:
Functional Area Name Signature Date
Head Production
Head Engineering
Quality Assurance
Protocol Approved By:
Functional Area Name Signature Date
Head Operation
Head Quality Assurance
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PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
2.0 Objective:
The objective of this protocol is to provide an outline for the performance qualification of Depyrogentaing and
Sterilizing Tunnel installed in Washing area of Dry powder Injectables and to verify that;
➢ The Tunnel performs according to its pre-defined specifications and qualifies for its intended purpose.
➢ The performance data of the Tunnel is documented for future reference.
➢ Release of Tunnel for routine use.
2.1 Scope:
This protocol will be implemented for performance qualification of Depyrogenation and Sterilizing Tunnel
supplied by M/s. ………, in order to check whether the Machine gives required Sterilization/ depyrogenation
for Vials.
2.2 Re-qualification:
Performance Qualification of Dry Heat Steriliser shall be re-qualified in case of;
➢ Any change in the existing equipment, facility or system, which can affect the performance of the
qualified process.
➢ Once in six months ± 15 days. Only one cycle for minimum and maximum size of vials shall be
requalified.
Instructions:
1. For each data sheet, record the requested information in black ink.
2. In the "Verified" column, indicate that the item is inspected and verified according to pre-laid Specifications.
Verification can be by a visual examination referring literature and using a measuring device, etc.
3. After each data sheet is completed, put signature and date in the assigned space.
4. Where the required information is not available ‘Not Available’ shall be entered accordingly. A single diagonal line
shall be scribed through unused boxes and comments sections and “N/A” meaning “not applicable” entered, along
with initials and date of the person who enters the line.
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Protocol cum Report No.: Batch Size: 250 vials Page No.: 5 of 25
PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
3.0 Responsibilities:
3.1 Validation Team
(Comprising members from Production, Engineering, Validation and Quality Assurance)
• Prepares the performance qualification protocol.
• Ensures that the protocol is in compliance with current policies and procedures on equipment Qualification.
• Ensures that the content is sufficient, clearly defined, technically sound and accurate.
• Distributes the draft protocol for review and collates comments.
• Makes any necessary corrections to the protocol and answers queries from the reviewers.
• Distributes the finalized protocol for review and approval signatures.
• Execution of PQ protocol.
• Review of protocol, the completed qualification data package, and the final report.
3.2 Head – Production/Engineering/Validation/Operations
• Review and Approval of protocol, the completed qualification data package, and the final report.
• Assist in the resolution of validation deviations.
3.3 Head - Quality Assurance
• Review and Approval of protocol, the completed qualification data package, and the final report.
• Verification that the protocol test requirements are completed and properly documented for approval.
• Assist in the resolution of validation deviations.
4.0 Equipment Description & Identification:
4.1 Equipment Description
The machine shall be used for Sterilization / depyrogenation of different size of vial i.e. 7.5 ml, 10 ml, 15 ml,
20 ml & 30 ml etc through the use of a hot-air laminar air flow sterilizing tunnel. The instrument is being
used for sterilizing of glass vials. The height of the receptacles is not exceeds 100 mm. The tunnel is made
with, both in feed and out feed conveyor for continuous line installation between washing and filling
machines. The full belt width for carrying the vials is 750 mm. The air damper plate is adjustable, which is to
be done depending on the size of the vials.
The machine is having a sterilizing zone, comprising a closed housing with built in filters, the hot air is
calculated at 350˚C / 662˚F the air heating elements are located in the hot zone and the air temperature is kept
constant by the use of regulating device the sensor needed for this are located in the direct air current beneath
the filters. The cooling zone continuous to sterilizing zone is designed as a laminar flow unit and protects vial
during transit through tunnel. When integrated with a washing machine and a filling machine the vials are
transported and controlled automatically.
PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT FOR
DEPYROGENATING & STERILIZING TUNNEL
Protocol cum Report No.: Batch Size: 250 vials Page No.: 6 of 25
PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
4.2 Name 0f The Equipment : Dry Heat Steriliser (Tunnel)
4.3 Make : M/s…………...
4.4 Model /Serial No : ……………….
4.5 Equipment Identification No. : ……………….
4.6 Equipment Location. : Injection (Room No.: ………..)
Remarks (if any):
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
Verified By & Date:…………….
PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT FOR
DEPYROGENATING & STERILIZING TUNNEL
Protocol cum Report No.: Batch Size: 250 vials Page No.: 7 of 25
PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
5.0 Methodology for Performance Qualification:
5.1 Parameters to be checked:
5.1.1 Air supply inspection of HEPA filters of different zones in sterilization tunnel before study of heat distribution & penetration study.
a. Integrity test of HEPA filter
b. Air velocity
c. Non viable particle count
d. Air flow pattern
5.1.2 Heat distribution studies
a. With calibrated data Logger & thermocouple.
5.1.3 Heat penetration studies
a. With calibrated data Logger & thermocouple.
b. With Endotoxin Challenge Test.
5.1.4 Data logger & thermocouple calibration (Pre calibration and Post calibration)
5.2 Process Variables:
a. Size of vial to be validated : ________________________
b. Type of Vial : ________________________
c. Conveyer speed : ________________________
5.3 Test Plan:
5.3.1 Air supply inspection of HEPA filters (Integrity Test of HEPA)
Test equipment required:
Aerosol Photometer
Aerosol Generator
Switch ON the Sterilization Tunnel to reach the operating condition for at least half an hour and then Switch
OFF the heaters to cool down and then check the integrity of HEPA filters as per respective SOP.
Scan the down streamside of HEPA filter using overlapping strokes with the photometer probe. Scan the
entire surface area and perimeter of filter including the junctions between the filter and the filter-mounting
frame.
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5.3.2 Air Velocity HEPA Filters:
Test equipment required: Anemometer
Switch ON the Sterilization Tunnel to reach the operating condition allow the pressure of different zones to
get stabilize for at least half an hour and then Switch OFF the heaters to cool down.
Measure the air velocity of HEPA filters as per respective SOP & take the reading of Air Velocity under each
filter.
5.3.3 Non-viable Particle counts
Test equipment required: Particle counter
Switch ON the Sterilization Tunnel to reach the operating condition and allow the pressure of different zones
to get stabilize for at least half an hour and then Switch OFF the heaters to cool down. Take the readings of
particle count of different zone of Tunnel as per respective SOP.
5.3.4 Air flow pattern for intersection flow of Tunnel:
Switch ON the blower of Sterilization Tunnel to reach the operating condition and allow the pressure of
different zones to get stabilize for at least half an hour and then Switch OFF the heaters to cool down.
Take a smoke pencil and bring it near to the intersection of Drying-Sterilization zone, Sterilization & Cooling
zone and also do at the intersection of Vial filling room and exit of the sterilization Tunnel. Observe the
direction of smoke.
5.3.5 Heat Distribution studies of the Tunnel:
Ensure that all the process parameters are set to their respective values as being done for routine production
run. Tie 12 thermocouples with the help of Teflon tape together with S.S rod at equidistant through out the
width of the Tunnel. Care should be taken to avoid contact of the tips of the thermocouple with any solid part
of the Tunnel as well as SS rod. Put these thermocouples along width of the Sterilization Tunnel’s conveyor
belt as per Annexure-1.
Follow the standard operating procedure for the operation of Sterilization Tunnel and allow these
thermocouples to travel the tunnel. Switch ON the Data logger. Observe the temperature profile being
achieved for each thermocouple. Take out the Temperature profile of data logger & from temperature
recorder of Tunnel. Check the FH value for each probe of data logger.
Calculate FH value based on the given formula and check the results against the acceptance criteria for
compliance.
Formula: FH = dt 10(Ta- Tb)/Z
Tb =250oC, Z= 46.4
Ta = Actual temperature
dt: Interval between two successive measurement.
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5.3.6 Heat Penetration Studies of the Tunnel:
Ensure that all the process parameters are set to their respective values as being done for routine production
run. Put 12 thermocouple of Data logger into individual vial and tie it with Teflon tape in such a way that it
touches the inside bottom of the vial. Distribute these vials at equidistant through out the width of the
Tunnel’s conveyor belt as per Annexure - 1. Take run for the START of the load, in the MIDDLE of the load
and at the END of the load (i.e. three sub-runs for each individual run). Follow the standard operating
procedure for the operation of Vial Washing and Sterilization Tunnel and allow these Vials to travel the
tunnel. Switch ON the Data logger. Observe the temperature profile being achieved for each thermocouple.
Allow the thermocouple implanted with vials to travel the sterilization zone along with other vials. Check the
FH value for each probe of data logger.
Calculate FH value based on the given formula and check the results against the acceptance criteria for
compliance.
5.3.7 Endotoxin Challenge Test:
Spike 10 vials of required capacity, with 104 Endotoxin units each and dry the vials at 50 - 60°C. Ensure that
all the process parameters of tunnel are set as being done during routine production run. Distribute nine
spiked vials (properly numbered and identified) at equidistant through out the width of conveyor belt as per
Annexure-3. Take run for the START of the load, in the MIDDLE of the load and at the END of the load.
Keep one spiked vial as Positive control.
Follow the standard operating procedure for the operation of the Tunnel. Allow the spiked vials to travel the
sterilization zone along with other vials. Remove the identified numbered vials from the other end of tunnel
in the aseptic area aseptically. Collect these vials aseptically and send them to microbiological lab for
analysis of Endotoxin and check the results against the acceptance criteria for compliance and attached the
report to the validation reports.
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DEPYROGENATING & STERILIZING TUNNEL
Protocol cum Report No.: Batch Size: 250 vials Page No.: 10 of 25
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5.3.8 Data logger & Thermocouple calibration
Data logger and thermocouple should be pre & post calibrated to ensure that the temperature measurement
system is accurate and precise. It should cover entire range of temperature (100°C, 200°C, 300°C & 350°C),
which is subjected for the validation of Tunnel.
Remarks (if any):
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
Verified By & Date:……………
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6.0 Critical parameters and acceptance Criteria:
6.1 Heat distribution & penetration:
6.1.1 The FH value of each channel should be at least 30 minutes, during the sterilization and
Depyrogenation cycle. (Reference: PDA technical Report No: 03)
6.1.2 Sterilization temperature shall not be less than 300°C
6.1.3 Sterilization hold during heat distribution shall not less than 5 minutes.
6.1.4 Sterilization hold during heat penetration shall not be less than 3 minute.
6.1.5 The deviation in temperature from average is not more than ±12.5°C for each channel during
Sterilization hold period.
6.1.6 The Data logger & thermocouple is accurate to within ± 0.5°C.
6.2 Endotoxin Challenge test:
6.2.1 There should be minimum 3-log reduction of the initial Endotoxin units present for the de-
pyrogenation of Vials.
6.3 Air supply inspection:
6.3.1 Photometer readings down stream of HEPA filtration unit should be less than 0.01%.
6.3.2 Air Velocity at each point HEPA filter should not be less than 0.45 meter/second.
6.3.3 The particle count reading of each zone should comply with class 100 areas (Particles of size >
0.5µm Not more than: 100 and > 5.0µm Not more than: 01 per feet3).
6.3.4 The direction of smoke should be from Sterilization Drying zone and also from
Sterilization zone Cooling zone. Also the direction of smoke should be from vial filling
depyrogenating Tunnel.
Remarks (if any):
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
Verified By & Date:………………………..
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7.0 Verification of Reference Documents:
S.No. Subject/Title of Document Document No. Verified by
1. SOP for Operation & Cleaning of Depyrogenating & Sterilization
Tunnel
2. SOP for Preventive Maintenance of Tunnel
3. SOP for Integrity testing of HEPA filters
4. SOP for Particulate matter count monitoring
5. SOP for Air velocity measurement
6. SOP for Endotoxin challenge test
8.0 Verification of Materials required:
S.No. Item/Reagent required Manufacturer/
Supplier
Batch No./AR
No. Expiry Date
Location of
Certificate Of
Analysis
Verified By
1. Smoke generating agent
(Titanium tetrachloride)
2.
Vials Type:
___________
Size : ____________
3. LAL
4. Endotoxin 10,000
5. LAL Reagent Water
Remarks (if any):
________________________________________________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________________________________
Verified By & Date:…………………….
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9.0 Training Records:
SUPERVISORY STAFF
S.No Area of training Name of trainee Training on protocol is given*?
(Yes/ No) Checked by
1.0 Vial Sterilization &
De-pyrogenation
2.0 Engineering
3.0 Production
4.0 Validation
5.0 Quality Assurance
6.0 Microbiological
7.0 Others (Specify):
OPERATORS
8.0 Tunnel Operation
9.0 Vial washing Machine
10.0 Others (Specify):
Name of the Trainer: ______________
Remarks (if any):
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
Verified By & Date:……………
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10.0 Test Equipment Details:
Review the calibration status of the test equipment including the temperature probes of the data logger to be utilized in
performance qualification testing and record the calibration due dates in the table below. All equipment / instrumentation
must remain within the calibration due date for the duration of PQ test for which the item is used. If a due date potentially
occurs during the testing period then the instrument must be recalibrated before it can be utilized.
S.No. Test Instrument ID Calibration
Certificate No. Calibration Date Next Calibration Due
Checked
By & Date
1. Aerosol Photometer
2. Anemometer
3. Particle Counter
4. Channel – 1
Temperature Sensor-1
5. Channel – 2
Temperature Sensor-2
6. Channel – 3
Temperature Sensor-3
7. Channel – 4
Temperature Sensor-4
8. Channel – 5
Temperature Sensor-5
9. Channel – 6
Temperature Sensor-6
10. Channel – 7
Temperature Sensor-7
11. Channel – 8
Temperature Sensor-8
12. Channel – 9
Temperature Sensor-9
13. Channel – 10
Temperature Sensor-10
14. Channel – 11
Temperature Sensor-11
15. Channel – 12
Temperature Sensor-12
Remarks (if any):
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Verified By & Date:……………………..
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11.0 Dry Heat Steriliser (Tunnel) Test Details:
S.No. Details Observation
1. Previous Qualification Details
(Date, Vial Size, etc.)
2. Pressure differential of zones in tunnel
3. Pressure differential of Filling and
Washing Area
4. Temperature of washing and filling area
before start of study
5. Duration of study (hours)
6. Machine set parameters
6.1 Control probe of tunnel
6.2 Set temperature of Heater – 1
6.3 Set temperature of Heater – 2
6.4 Set temperature of Heater – 3
6.5 Set temperature of Heater – 4
6.6 Conveyor start temperature
6.7 Conveyor Stop temperature
6.8 Too high temperature
6.9 Conveyor speed
Remarks (if any):
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Verified By & Date:……………………..
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12.0 Records of Observations and Results:
12.1 Observations of Study of HEPA integrity, Air velocity of HEPA filters, particle count and air flow pattern test.
Test Parameter Observations Verified
by/Date Location Acceptance criteria Result
HEPA integrity
Drying zone
Filter –1
Penetration should be less than
0.01%
Sterilization zone
Filter – 01
Filter – 02
Filter – 03
Filter – 04
Cooling zone
Filter – 01
Filter – 02
Average Air
velocity
Drying zone
Note less than 0.45 m/s (89 feet /
minute)
Sterilization zone
Cooling zone
Particle count
Drying zone
Location –1
Location –2
Location –3
Location –4
Particles of
≥0.5µm: Not more than 100
particles/ ft3.
Particles of
≥5.0µm: Not more than 1
particle/ ft3.
Sterilization zone
Location –1
Location –2
Location –3
Location –4
Cooling zone
Location –1
Location –2
Location –3
Location –4
Air flow pattern
Sterilizing zone, drying
zone, cooling zone and
filling area
Sterilization zone to drying zone
Sterilization zone to cooling zone
Vial filling to sterilizing zone Drying zone
Remarks (if any):
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Verified By & Date:……………………..
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12.2 Observations of Heat Distribution Study (Type _________________)
Process Parameter Observations Verified by/Date
Start Time
Stop Time
Differential pressure of washing and filling area.
Differential Pressure drying zone
Differential Pressure sterilizing zone
Differential Pressure cooling zone
Speed Of Tunnel During Sterilization Hold (Min &
Max)
Sterilization Hold Time started at
Sterilization Hold Time ended at
Sterilization Hold Time
Limit: Not less than 5 Minutes
Complies /Not complies
Maximum Temperature deviation in positive side from
average for all probes
Limit: Not more than +12.5°C
Complies /Not complies
Maximum Temperature Deviation in negative side
from average for all probes
Limit: Not less than -12.5°C
Complies /Not complies
Maximum temperature (From all probes)
Not less than 300°C and not more than 350°C.
Complies /Not complies
Minimum temperature (From all probes)
Not less than 300°C
Complies /Not complies
Minimum FH value (Compare all probes)
Limit: Not less than 30
Complies /Not complies
Maximum FH value (Compare all probes)
Limit: Not less than 30
Complies /Not complies
Remarks (if any):
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Verified By & Date:……………………..
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12.3 Observations of Heat Penetration Study [(Type ____________________ (Run 1)]:
Process Parameter Observations
Verified by/Date Initial Middle End
Start Time
Stop Time
Differential pressure of washing and filling
area.
Differential Pressure drying zone
Differential Pressure sterilizing zone
Differential Pressure cooling zone
Speed Of Tunnel During Sterilization Hold
(Min & Max)
Sterilization Hold Time started at
Sterilization Hold Time ended at
Sterilization Hold Time
Limit: Not less than 3 Minutes
Complies /Not complies
Maximum Temperature deviation in positive
side from average for all probes
Limit: Not more than +12.5°C
Complies /Not complies
Maximum Temperature deviation in negative
side from average for all probes
Limit: Not more than -12.5°C
Complies /Not complies
Maximum temperature (From all probes)
Not less than 300°C and not more than 350°C.
Complies /Not complies
Minimum temperature (From all probes)
Not less than 300°C
Complies /Not complies
Minimum FH value (Compare all probes)
Limit: Not less than 30
Complies /Not complies
Maximum FH value (Compare all probes)
Limit: Not less than 30
Complies /Not complies
Endotoxin test
Limit: 3 log reduction
Complies / Not complies
Remarks (if any):
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Verified By & Date:……………………..
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12.4 Observations of Heat Penetration Study [(Type ____________________ (Run 2)]:
Process Parameter Observations
Verified by/Date Initial Middle End
Start Time
Stop Time
Differential pressure of washing and
filling area.
Differential Pressure drying zone
Differential Pressure sterilizing zone
Differential Pressure cooling zone
Speed Of Tunnel During Sterilization
Hold (Min & Max)
Sterilization Hold Time started at
Sterilization Hold Time ended at
Sterilization Hold Time
Limit: Not less than 3 Minutes
Complies /Not complies
Maximum Temperature deviation in
positive side from average for all probes
Limit: Not more than +12.5°C
Complies /Not complies
Maximum Temperature deviation in
negative side from average for all probes
Limit: Not more than -12.5°C
Complies /Not complies
Maximum temperature (From all probes)
Not less than 300°C and not more than
350°C.
Complies /Not complies
Minimum temperature (From all probes)
Not less than 300°C
Complies /Not complies
Minimum FH value (Compare all probes)
Limit: Not less than 30
Complies /Not complies
Maximum FH value (Compare all probes)
Limit: Not less than 30
Complies /Not complies
Endotoxin test
Limit: 3 log reduction
Complies / Not complies
Remarks (if any):
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Verified By & Date:……………………..
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12.5 Observations of Heat Penetration Study [(Type ____________________ (Run 3)]:
Process Parameter Observations
Verified by/Date Initial Middle End
Start Time
Stop Time
Differential pressure of washing and
filling area.
Differential Pressure drying zone
Differential Pressure sterilizing zone
Differential Pressure cooling zone
Speed Of Tunnel During Sterilization
Hold (Min & Max)
Sterilization Hold Time started at
Sterilization Hold Time ended at
Sterilization Hold Time
Limit: Not less than 3 Minutes
Complies /Not complies
Maximum Temperature deviation in
positive side from average for all probes
Limit: Not more than +12.5°C
Complies /Not complies
Maximum Temperature deviation in
negative side from average for all probes
Limit: Not more than -12.5°C
Complies /Not complies
Maximum temperature (From all probes)
Not less than 300°C and not more than
350°C.
Complies /Not complies
Minimum temperature (From all probes)
Not less than 300°C
Complies /Not complies
Minimum FH value (Compare all probes)
Limit: Not less than 30
Complies /Not complies
Maximum FH value (Compare all probes)
Limit: Not less than 30
Complies /Not complies
Endotoxin test
Limit: 3 log reduction
Complies / Not complies
Post calibration of data logger Channels
and temperature probes
Complies /Not complies
Remarks (if any):
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Verified By & Date:……………………..
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PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
13.0 Deviation Sheet:
Report any deviation from the acceptance criteria or from protocol instructions in the Deviation report form of
Appendix 1. Record the total number of deviations reported during the performance qualification activities of this
Protocol. Record the Deviation number and Title in the Table below. Include all Deviation Report Forms in
Appendix 1. Indicate the status of each variance as ‘Closed’ only when the Deviation is resolved.
Deviation No. Deviation Title Status
Total No. of Deviations: ___________
Remarks (if any):
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Verified By & Date:……………………..
PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT FOR
DEPYROGENATING & STERILIZING TUNNEL
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PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
14.0 List of Annexures:
Annexure No. Document Title
Remarks (if any):
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………
Verified By & Date:……………………..
PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT FOR
DEPYROGENATING & STERILIZING TUNNEL
Protocol cum Report No.: Batch Size: 250 vials Page No.: 24 of 25
PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
15.0 Summary & Conclusion:
16.0 Post Approval of Performance Qualification:
Functional Area Name Signature Date
Head Engineering
Head Production
Head Operation
Head Quality Assurance
PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT FOR
DEPYROGENATING & STERILIZING TUNNEL
Protocol cum Report No.: Batch Size: 250 vials Page No.: 25 of 25
PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT
Appendix 1: Deviation and Corrective Action Report Form
This Deviation and Corrective Action Report Form shall be completed for each result that does not meet the expected or as
designed condition encountered during the execution of the protocol. Each form shall be numbered sequentially and tracked
on the Deviation Sheet within the protocol.
Deviation Report Number:
Protocol Section No.: Date of Test:
Description Of Test Result:
Immediate Action Taken:
Corrective Action Taken/ Planned:
Deviation Reported By:
Name: Signature: Date:
Corrective action must be taken prior to approval of PQ:
Head-Engg. Signature
Date:
Head-User dept. signature Date:
QA Signature: Date:
Corrective Action Implemented:
Corrective Action Implemented By:
Name: Signature: Date:
(Attach comments and supporting documentation as necessary)
Was a re-test or amendment necessary due to the Deviation? Date of re-test:
Is Deviation Closed (Yes/No):
QA Signature: Date: