Depyrogenation tunnel Validation / Qualification tests in Pharmaceutical industry

Depyrogenation tunnel Validation / Qualification tests in Pharmaceutical industry
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Time stamps

00:00 Introduction
00:10 Table of contents
00:35 Air flow velocity test
01:40 Filter system leakage test
03:13 Tunnel belt / conveyor speed verification
04:10 Non viable particle count
05:05 Heat penetration and endotoxin challange study
05:55 End screen
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In this video you will get

1. Air flow velocity test

Objective : To determine the factors than may affect cross- sectional air velocity distribution in tunnel – ventilated system and is capable of delivering air velocities
Key points :
Test shall be performed for at least 30 minutes
Measure velocity 6 inch below the filter
Take velocity reading at 5 locations

Acceptance Crieteria : Air velocity should be maintained within 90 fpm +/- 20% of mean unit velocity for even distribution of temperature

2. Filter system leakage test
Objective : To verify the integrity of HEPA filter installed in the sterilization and depyrogenation tunnel. HEPA filter installation has been done properly and qualifies the filter integrity test.
Equient used : Aerosol generator and Aerosol Photometer
Key Points :
Aerosol concentration : 80-120 mg/meter cube
Scan the downstream side of HEPA filter.
Acceptance Crieteria : Photometer reading should be less than 0.01 % of the upstream challange concentration of the aerosol 100%.

3. Tunnel belt/conveyor speed verification
Objective : To ensure the tunnel conveyor belt speed meets the requirements as specified.
Equipments used : Vernier calliper
Key point : Start the stopwatch when advance signal reaches the start position and run for 1 minute
Acceptance crieteria : Conveyor speed shall not vary more than 3% of set speed

4. Nonviable particle count
Objective : To establish that at different location within the tunnel, count size of particle per cubic meter is within the limit.
Key points : Switch on particle counter and place the isokinetic probes at specified location under the filter of conveyor belt of tunnel and observe the reading.
Acceptance crieteria : The particle counts taken under the HEPA filter in the different zones of sterilizing tunnel should meet the requirements of ISO 5 / Class A.

5. Heat penetration and endotoxin challange study

Objective : To ensure that heat is sufficiently penetrating into the inner most portion of the vial / ampoule subjected for sterilization and depyrogenation cycle.
Key points : Use vial with approx 10000 EU/vial of bacterial endotoxin. Place minimum 10 numbers of probes, one probe each inside the endotoxin spiked 8 vials and 3 without spiked vials.
Acceptance crieteria : All themperature measured in the chamber is more than 300 degree celcius. The recovery of endotoxin concentration after in sterilization and depyrogenation should be at least 3 log reduction.

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