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March 2020


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"Berman, Alison" <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Fri, 6 Mar 2020 13:14:06 +0000
text/plain (2560 bytes) , image001.png (21 kB)
Hello all,

In the case of media fill vials, guidance calls for an incubation range of 20-35C for not less than 14 days and allows you to validate as appropriate with a single or dual temperature. I would like to know how companies are incubating their units and if dual, ensuring 20-25C incubation is performed first.

In the case of routine EM/PM sampling for aseptic process monitoring, there had been a shift in thinking over the past few years. There was a lot of discussion of changing incubation of general media at 30-35C for NLT 72 hrs followed by 20-25C for NLT 3-5 days to a single temperature (maybe 28-32) for NLT 72 hrs. Has anyone done this?

Has anyone ever had a citation from an auditor for incubating media fill units at the lower temp first but incubating the routine EM/PM samples at the higher temp first?


Alison Berman, MFS
Quality Control - Microbiology

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