While running the autoclave validation if any of the probes may attain > 124.5.is it acceptable ?if so how can we justify it?
What is the set-point on the autoclave? What is the mean of the rest of the locations? Is any equipment heat labile (can overheating it damage it)?
All locations within the autoclave should be within a specified range for uniformity. This shows that there is consistent air removal/steam penetration.
123
Check out this previous discussion
http://forum.askaboutgmp.com/t/autoclave-pq-uniformity-of-2c/2714