Since all these years my company only do heat distribution and heat penetration for empty & max load for our rubber stopper (aseptic process). Without naming which PIC/S authority, my company was given a finding because we never validate the minimum load for our rubber stopper sterilization.
We are really mad because we have to do minimum load not just for rubber stopper, but also for all other load cycle.
I think the regulatory body espescially the auditor need to understand that these PQ practices (empty, min and max) is costly and time consuming. We understood that it is compulsory for ‘Terminal Sterilization’. And most guidelines also prefer it that way. (Except PIC/S; which they didn’t have complete guidelines on 'terminal sterilization).
In a word, I would like to suggest that, we should simplify the autoclave PQ by :
1). skipping the minimum load study espescially for non-critical load OR,
2). we could just add ‘one empty tray’ as the standard min load study.