What are the guidelines for autoclave re-Validation?

The Question posed on LinkedIn:

Dear Experts, What are the guidelines that clarify the frequency and number of cycles required for re-Validation of equipment? For example, during re-qualification of the autoclave should each cycle be repeated 3 times (empty, minimum and maximum loads)? Or is it based on risk assessment by choosing the maximum loads only? (On initial qualification each cycle was performed 3 times consecutively). Also for depyrogenation tunnels, should the runs be repeated 3 times? Thank you

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Autoclave Validation

Updated June 2020:

With the age of my presentation and the recent PE009-14 update it was high time to review and update my Autoclave Validation training/presentation.

The linked to pdf contains Autoclave Validation training I have presented in person and via teleconference.

The purpose of the training is as follows:

  • What is an autoclave
  • Why we use autoclaves
  • Identify the two main types used by us
  • Detail how to validate an autoclave (including loading patterns)
  • What to look for in an audit

It is important to note that this training was developed in 2008.  Some references may be out of date.  The overall thinking and methodology remains valid.

Autoclave Validation Presented by Paul Yeatman Bsc – 2020 (pdf)

Autoclave Validation – 2006 version (pdf).

Additional Autoclave Validation Documentation