Autoclave Qualification: 2K Temperature Difference, & 1K Fluctuation in Empty Chamber Test

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Dear all,

There is a criteria that states that the maximal difference in temperature between all mapping points in a chamber cannot be more than 2K at any moment throughout the holding phase

There is another criteria that stated that the maximal fluctuation of one mapping point throughout the holding time cannot be more than 1K.

I know the first one is more or less stated for the small and large pack in the EN285:2016 norm, but what about the second one (1K). Where does this one come from? Or is this one no longer applicable?

Thanks for your support,

2

The fluctuation was indicated in obsolete HTM2010, while current EN285 does not. I’m also puzzled on this requirement of HTM. When the allowable temperature band for the chamber/process is 3K, but yet at each individual point is fluctuation of +/-1K (2K). I’m thinking of removing from our site procedure, but met with disagreement.