Autoclave Revalidation

GOOD VALIDATION PRACTICE (cGVP)
1

I was hoping someone could help me with this. During autoclave requalification how many different max/min loads need to be included in the protocol. We currently run 1 cycle recipe and have several different equipment loads.

Do I need to include all of the max/min loads? Or is it possible to justify running 1 max/min load if you can say it is the “worst case load”?

Also, can I get away with running 1 time for a requalification or do I need to have 3 runs?

2

Hi

Previously i have run one max load, one min load and one worst case load during a requalification. (three in total)

The max and min were same recipe and the worst case was subminimal dose.

Hope this helps