Few queries about autoclave validation

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

Hello All
Your suggestion on the following queries would be helpful.

  1. If I want to procure data loggers for autoclave validation what criteria should I look for?
  2. What type of equipment would be suitable for non-condensable gas determination in the autoclave?
  3. How do I calculate fluctuation criteria (±1°C) during autoclave validation?

we would like to meet the regulatory audits like (FDA, MHRA andTGA)

thanks

2

Hello Shougata,

  1. Most of the places i have worked use GE Healthcare Kaye2000, for temp mapping
  2. I think EN285, HTM2010 or PDA Tech Report might be a good start.
  3. I’m not sure what you are asking here. The Kaye is capable of many functions including F0.

gac70

3

thanks for the reply.
My No.3 query is how the fluctuation is measured? is it Max-Min? or Avg temp-Max/Min during the holding time?
thanks

4

Hello Shougata,

The guidelines are very good. They go into things like overshoot, ramp up period and what the spread between thermocouples should be.
If you are looking at the hold period i.e 20 mins, i’m sure there is section on what the spread between the T/Cs should be.