Acceptance Criteria Autoclaves

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
1

Hello all,

We have a specification of 121-124 degrees for the autoclave PQ. The guys want to round up and down to meet these specs. Eg if its 120.6 it can be rounded up to 121 and if its 124.4 it can be rounded down to 124 therefore meeting specs during PQ using the thermocouples.
I have worked at a number of sites and there has never been an issue. If the specs are 121-124 and the thermocouples were below 121.0 and above 124.0 then they would raise a deviation.
Does anyone have any experience of this and is this acceptable?

Thanks

2

Here the issue is that you are not attaining the prescribed temperature of 121C at some points. That is there are still cold spots in your autoclave. I have never heard any one rounding off. It should be either 121C or more.
With basic information you gave what I suggest you is that arrange your loads and rework till all the thermocouples reach 121C.
Honestly speaking if it does not attain 121C in PQ it will never reach 121C during production runs.
One more suggestion I would like to give is that Calibrate those thermocouples. Then start PQ.

3

Thanks for that. Just needed the sanity check