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Subject:
From:
Bob Westney <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 27 Nov 2018 12:20:54 -0500
Content-Type:
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Dual incubation of a single medium is current industry practice and agency
expectation (barring qualification of a single-temperature incubation
scheme).  The regulations are too old to provide any guidance.

USP <1117> states:

"Selection of Culture Conditions

Time and incubation temperatures are set once the appropriate media have
been selected. Typically, for general microbiological growth media such as
SCDM, incubation temperatures in the ranges of approximately 20°–35° have
been used with an incubation time of not less than 72 hours. Longer
incubation times may be considered when contaminants are known to be slow
growing. The temperature ranges given above are by no means absolute.
Mesophilic bacteria and mold common to the typical facility environment are
generally capable of growing over a wide range of temperatures. For many
mesophilic organisms, recovery is possible over a range of approximately
20°. In the absence of confirmatory evidence, microbiologists may incubate
a single plate at both a low and a higher temperature. Incubating at the
lower temperature first may compromise the recovery of Gram-positive cocci
that are important because they are often associated with humans."

A few years ago, Dr. Tim Sandle wrote this article:

https://www.researchgate.net/publication/266394440_Examination_of_the_Order_of_Incubation_for_the_Recovery_of_Bacteria_and_Fungi_from_Pharmaceutical-grade_Cleanrooms

Bob Westney
Director of Quality and Operations
Cryologics, Inc.
www.Cryologics.com

On Tue, Nov 27, 2018 at 11:32 AM Joel Russo <[log in to unmask]> wrote:

> 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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The Microbiology Network (http://microbiologynetwork.com) and supported by
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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

Sartorius https://promotions.sartorius.com/real-heroes

Steris - http://www.sterislifesciences.com/

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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