Because the "bugs don't lie" and assume you have confirmed the growth on the
two BIs that showed growth to be B. stearothermophilus, I consider this
study to
have failed-- you have not demonstrated the efficacy of sterilization process.
You will therefore have to investigate the operational history of the
autoclave,
reviewing equipment history reports, PMs, change controls, personnel training,
validation records, etc. Consequently, you will probably have to increase the
dwell time and/or temperature.
(Incidentally, I had an experience where a T/C temperature recorded low
temperatures (accumulated Fo value at end of run was approx. 6 min. but the BI
showed no growth).
Aris Koumandaros
aris.koumandaros@pharma.Novartis.com
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