Depyrogenation Tunnel Performance Qualification, Purpose
Depyrogenation Tunnel Performance Qualification, To authenticate and document that the performance of the Depyrogenation Tunnel of Sterile Production area (Cephalosporin Block) of XX Pharmaceutical Limited (PPL) is satisfactory in all critical aspects related to the operational requirements. This protocol describes the performance qualification procedures of the Depyrogenation Tunnel manufactured by Tofflon, China.
Depyrogenation Tunnel Performance Qualification, Scope
This Performance Qualification (PQ) is to be performed against agreed acceptance criteria on the vials of three sizes such as 7.5 ml, 15 ml and 30 ml, which will be sterilized by the Depyrogenation Tunnel installed in the Sterile Production area of Cephalosporin Block of XX Pharmaceutical Limited.
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Responsibilities
Preparation of the protocol
[][]Validation (Engineering) Department with the assistance of Microbiology, Engineering and Maintenance department.
Executing the protocol
[][]Validation (Engineering) Department along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
Microbiological Challenge Test
[][]Microbiology department
Data documentation and preparation of the report
[][]Validation (Engineering) department.
Verifying of the report
[][]Concerned departmental person.
Providing documentation on the equipment
[][]Related departments i.e. Engineering, Production, Microbiology, Validation or other appropriate departments and manufacturer.
Equipment Information
=>Manufacturer : Tofflon, China
=>Capacity : 6000-9000 vials /hr
=>Model : SZA 620
=>Serial no. : YF2014-078B
The Equipment under test
[][]The Depyrogenation tunnel under validation study has the following segments:
=>Pre-heating zone
=>Sterilization zone
=>Cooling zone
[][]The whole production process combines in a line consecutively with a Vial washing machine, Depyrogenation tunnel, Vial Filling machine and Cap sealing machine.
[][]The washed Vials are conveyed into the Pre-heating Zone of the Depyrogenation tunnel automatically after washing in the vial washing machine.
[][]The Vials are flooded with sterile air in this zone. The temperature controlling preset values maintain the circulating air temperature at that preset value.
[][]The warm Vials are then transported into the Sterilizing Zone and are sterilized & depyrogenated by a low turbulence air flow (up to 300°C). The air is heated in an air circulation duct and then flows through the high temperature HEPA filters prior to reaching the vials.
[][]These filters ensure that the air quality corresponds to clean room class A (class 5 according to ISO 14644) in all operation modes, even in the heating and cooling phases. In the last work zone (cooling zone) of the tunnel, the sterilized Vials are cooled down by a vertical low turbulence air flow.
[][]The discharge from the tunnel opens into a clean room where the depyrogenated Vials are stored on a turn table and conveyed by belt transfer system to the infeed of filling machine.
Checking Parameters
[][]The PQ of Depyrogenation Tunnel will be carried out to evaluate the following conditions to confirm the sterilization conditions:
=>Heat Penetration (HP) studies.
=>Microbiological Challenge (MC) test using Endotoxin Challenge Vials.
The system/ equipment to be used as Standard for testing
[][]Performance of the Depyrogenation Tunnel will be judged based on thermal and biological studies which are mentioned below:
=>Equipment Name: Anville Data Logger, TQ Soft Version 6.1.2 with thermocouples.
=>Requirement for challenge test: -Endotoxin Challenge Vials.
Pre requirement For Validation:
[][]Calibration of thermocouples of the data logger/Validator before and after validation with proper identification.
[][]Valid calibration record of Data Logger/Validator.
[][]Data logger reading intervals set at 30 seconds (maximum).
[][]Successful calibration of the Temperature sensors of Depyrogenation Tunnel.
[][]Successful completion of IQ and OQ.
[][]Endotoxin Challenge Vials for ensuring 3 log reduction.
Study Procedure:
Heat Penetration (HP) Study:
[][]The equipment must be run three times at fully loaded condition for each size of vial where seven thermocouples are exposed to monitor the temperature within the loads.
[][]The number of measurement points will be dependent of the width of the tunnel. As the width of the tunnel is 590 mm, seven thermocouples will be placed at 98 mm distance from each other as shown in Appendix – 01.
[][]The conveyer belt of the tunnel will be run at about 98.4 mm/min and 90.2 mm/min for 7.5ml, 15ml and 30 ml vials respectively.
[][]Care must be taken to avoid contact between the thermocouples and the metal surface of the chamber. Evenly distribute the thermocouples as it is shown in the Appendix – 01.
[][]The Results of this test will be recorded in the Appendix-03 (Number of this appendix will be increased as per number of cycles) and will be accepted if met the acceptance criteria.
Microbiological Challenge (MC) test:
[][]This test will be performed while performing the HP study. Seven Endotoxin challenge Vials (ECV) are distributed along with the thermocouples at defined positions of conveyer belt of tunnel at fully loaded condition as per specified load pattern as specified in Appendix -1.
[][]After completion of the cycle ECVs will be tested by the microbiology department for required log reduction.
[][]The results of above test should be recorded in the designated form (Appendix-4).
Acceptance Criteria
For Heat Penetration (HP) study:
[][]During sterilization period; all thermocouple readings must be within set temperature (300deg.C)±15deg.C.
[][]During sterilization period; when all thermocouples are showing a minimum of 285deg.C, temperature difference among the thermocouples are not more than 15deg.C.
[][]For cooling zone performance study:
[][]After passing sterilization zone, minimum reading of all thermocouples are below 35deg.C.
For Microbiological Challenge Test:
[][]The ECVs not exposed to the Depyrogenation cycle (control) should show clot after incubation at time and temperature as per COA.
[][]The Endotoxin content of a challenge vial must be reduced at least 1000 fold (> 3 log reduction).
Deviation And Failure Investigation Summary
In the column below, record any deviations or failures that occurred during the PQ exercise.
| Deviation/ Failure No. | Description and Assessment of Impact on Validation | Initial | Date |
|---|---|---|---|
| 1 | |||
| 2 | |||
| 3 |
Reference Documents
[][]FDA Guidance for Industry ( for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products).
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Depyrogenation Tunnel Performance Qualification Protocol