We are a contract laboratory, and we prepare, sterilize, and growth-promote
the majority of the agar and broth media that we use to test our clients'
products. The contents of our autoclave loads can vary quite significantly,
depending on what types of analyses we have in-house/ what type of media we
require on a given day.
Based on the above, it is not realistic for us to specifically qualify every
possible load pattern that we may use. In our annual autoclave
re-qualifications, we typically validate our liquid cycle for a couple
configurations of maximum (chamber packed with large volumes of agar media)
and minimum (chamber containing small volumes of broth media) loads. We
include thermocouples and BI ampoules in the loads, and test media for
growth promotion post-sterilization.
We believe this validation study qualifies all media load patterns that we
run, as long as they contain volumes of media within the validated range. I
am just wondering if this sounds reasonable to the PMF, as we have recently
had to defend this approach.
Please offer any opinions you may have on the subject, and industry
references/ guidelines that may be helpful.
Thanks so much
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