Autoclave - vaccum leak test failed

Hey. I have a problem with the autoclave. Our vacuum leak test does not come out properly. From time to time the results are less than 1.3 mbar / min but usually the results are failed. Autoclave servis offered to increase the range to about 2.5-5 mbar / min and explained that other companies use higher ranges. According to PN-EN-285 permissible range is below 1.3 mbar / min. The autoclave is used to sterilize clothes, accessories and sterilizing medium to test sterility of the products in the class A / B. Is it permissible to increase?

Do you need to meet EN285?

Did you mention EN285 to your service representative?

Did he trouble shoot the autoclave sufficiently? Of course it is easier for him to increase the leak rate set point, so then he doesn’t have to deal with it. Unfortunately it is easier for him, and harder for you to now defend in an audit.

If it were me, even if we weren’t committed to En285, I would still want to meet EN285, in the eventuality that EN285 will be universally adopted and your company will chose or will be required to adopt it. In any case, it is safer and more robust to follow it.

Leaks could come from fittings, welds, gaskets. I would want to know the source and try to fix it.

I personally would not say it is acceptable to increase. I would consider changing service contractor based on above advise.

I would check the following first:

  • Is the chamber dry and empty prior to starting the test?
  • Can you get the chamber down to 40mbar? This should be pretty easy, if you cant you have a significant leak.
  • Are you allowing a 5 minute stabilisation time post vacuum, and if so what is the pressure increase during this time?
  • Are you running the test for 10 minutes, i.e. 13mbar/10minutes.
  • Is the vacuum line tight? A lot of these units have significant vibration due to the pump that can loosen off connections.