I have some doubts regarding autoclave validation.
If we have 5 different loads pattern and each of this have been validated initially. Now during revalidation, what should be the criteria for selecting the load? Do I need to take worst load pattern (as justified during the PQ) and have to revalidate it every 6 months or do I need to rotate my load so that all the load pattern are covered in a period of time. Also if I need to rotate my load, then by how many years (max) should I cover all the loads?
Also do I need to validate a minimum load pattern as well, just like maximum load pattern. If yes then how do I define my minimum load as it will keep changing depending on circumstances. Or can I justify saying that the empty run which has been validated is my minimum load?
Hi, generally you would have to to re-qualify every load/sterilisation cycle combination on a minimum annual basis. Typically you would not have to repeat the empty state as it is fine to do this once off in ithe initial qualification. But you would have to do all 5 load patterns which you have established as per your initial PQ, 3 consecutive successful runs and all. Note that of you change any aspect of the original load patterns or introduce a mixed load, you would end up with an additional stacking pattern, therefore a different load and an extra PQ test to complete. If in actual production sterilisation you use low and high loads for differennt cycles then you would certainly have to do these as well.
What you can do is rotate the testing throughout the year and perform your re-PQ concurrently as the different loads/sterilisation cycle combinations are encountered throughout the production cycle.
I wouldn’t necessarily do 3 no-load runs per cycle type, as this test is more applicable to OQ. It all depends on the scope of the PQ, type of cycles, load types, load patterns, etc. I would probably do single empty load runs on each cycle to be used and confirm that heat distribution has not changed significantly from initial OQ and is still within standard requirements. The ultimate aim of the annual PQ is to prove the clave’s continued, consistent suitability for use. The best way to do this would be via using the actual load pattern (min/max/half/full/mixed)/cycle type (gravity/pressure/vacuum, etc) combinations.
Dear forum member,
You can rotate these load patterns at least minimum in the year. The load pattern validated during PQ should remain same during revalidation also. At least every load should get revalidate once in a year.
The minimum load pattern should be designed as per production requirement. It should be little more in size than the normal production loads as it will cover all small changes in production load. You can not justify the empty load as minimum load
Aravind, For revalidation, all load configurations should be done once to confirm acceptance criteria are still being met. Need to do each configuration (worse case) since they must have differing attributes or you would not have had several in the initial validation. We typically do each pattern every year but do spread them out over several months so the autoclave isn’t tied up for too long. Example: January, Liquid Loads, March Hard Goods due, etc. Russ Nyberg
I would say re-validating “loads” is overkill. I’m not in agreement with some of the new guidances. What(why) are you actually re-validating? I wholly understand performing empty chamber runs to verify the integrity of the chamber. What changed to necessitate or could cause an overkill cycle to fail? (Less clean steam? traps not working?) Wouldn’t a robust change control system along with a comprehensive document review suffice? I think everyone reviews the cycle log, temperatures, times, pressures. Please explain what I am missing…all I see is a great risk in false positives and errant validation procedure rendering a perfectly good cycle questionable.