I have been struggling with acceptance criterion to interpret for autoclave qualification, namely equilibration time. I was hoping you could give me some input or an example of this criterion.
I have read numerous articles on this topic but cannot find a concrete example with actual values. Looking at some common definitions, I found the following:
Equilibration time: The period which elapses between the attainment of the sterilization temperature at the reference measuring point (usually chamber drain) and the attainment of the sterilization temperature within the porous load.
The question I have each time is, what is considered as the sterilization temperature? Would this be the set point of the hold time (e.g. 123.0 C) or the commonly accepted 121.1 C (even when the set point is higher, e.g. 123.0 C).
So by means of an example, if the hold time temperature set point is 123.0 C, does the equilibration time start when the reference measuring point reaches 123.0 C (and stops when all probes in the load reach 123.0 C) or when the reference measuring point passes 121.1 C (and stops when all probes in the load have also passed 121.1 C)?
Thanks a lot in advance for any input…