Autoclave - Leak Rate Tests

Aug 22 / Chris Maughan

If your autoclave uses a vacuum for any point of its cycle, you should perform a leak rate test. This includes both porous and fluids steam sterilisers.

The leak test is normally performed once a week and is used to confirm the integrity of the chamber. 

If you have a failed result, the source of the leak should be identified and resolved before running any production cycles.

How does a leak rate test work?

The leak rate test starts by pulling a vacuum to the setpoint, for example 50mBarA. Once reached all valves are closed and the vacuum pump is stopped. The stabilisation period is started which usually lasts for 5 minutes. 

After stabilisation the leak test is started, at this point the starting pressure is recorded. The test normally runs for 10 minutes and the end result is recorded and the pressure rise is recorded.

The acceptance criteria for a leak test is ≤13mBar/10 minutes.

Leak Rate Test Failure

Failed leak rate tests are a common occurrence. If you see a failure, contact your engineering team. They are usually due to:

  • Damaged Gaskets
  • Loose Clamps (Validation Ports etc.)
  • Door Seal Failures
  • A Wet Chamber
Lesson 

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