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From:
Timothy Cser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 27 Nov 2018 17:43:21 +0000
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Hi Joel.  I've seen both in publications but my personal experience is that a wider variety of molds will grow at a little lower than 30-35 being that you're recovering organisms from a (generally) cooler environment. That doesn't mean the molds wouldn't grow but either way, a study to justify the conditions is always a good idea.

Here are a few publications regarding the subject:

Access the most recent version at doi:10.5731/pdajpst.2014.00994
PDA J Pharm Sci and Tech 2014, 68 394-406
Oliver Gordon, Manfred Berchtold, Alexandra Staerk, et al.
Microbiological Environmental Monitoring

Tony Cundell publication:

https://www.americanpharmaceuticalreview.com/Featured-Articles/190686-Mold-Monitoring-and-Control-in-Pharmaceutical-Manufacturing-Areas/

PDA publication:
https://www.ncbi.nlm.nih.gov/pubmed/9752711

Tim Cser
916-759-1401
[log in to unmask]

MilliporeSigma

MilliporeSigma is a division of Merck KGaA, Darmstadt, Germany

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Joel Russo
Sent: Monday, November 26, 2018 12:11 PM
To: [log in to unmask]
Subject: [PMFLIST] EM testing for TYMC

Good afternoon all,

Am scouring the regs for an answer and haven’t come up with anything.  For EM testing of yeasts and molds, is it ever acceptable to only incubate plates at 30-35, regardless of the selectivity of the media used in the sampling?  In my previous experience, growing fungi occurs best at 20-25, regardless of media type, and have heard of large aseptic manufacturers get cited for only incubating at 30-35, and being required to rethink their incubation plan.

Kind Regards,
J. Russo
Consulting Microbiologist

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