Dear Forum members,
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?
Anticipating some clarification on this matter.
Thanking you in advance for the reply.