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Subject:
From:
Jeanne Moldenhauer <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 9 Mar 2020 10:31:57 -0500
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Allison

I just finished compiling all of the FDA 483's for the last 5 years for a
PDA book (available through the PDA website soon).  In that five year
period there are no citations for the incubation conditions you talk
about.  However, there have been comments/questions regarding the basis for
the incubation conditions used, i.e., you should have data or published
literature to identify why you chose the conditions you used.

Published literature gives several different approaches.

DuMoulan, et al. showed that a temperature of 32.5 deg C + 2.5 deg C was
the best temperature overall for growth of microbes for sterility testing.
(They were validating a rapid method)

Other publications say for biphasic temperatures to do the lower
temperature first so you don't harm the fungi.  Other compendia indicate
that you should do the 30-35 deg c temperature  first to protect the human
borne organisms.

The best thing to do is to run an incubation conditions validation study.
I published instructions for this type of testing in the IVT journal.  None
of my clients who have validated incubation have had any issues on
incubation conditions from any regulator.

Jeanne Moldenhauer

On Fri, Mar 6, 2020 at 7:53 AM Berman, Alison <[log in to unmask]>
wrote:

> 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?
>
> Thanks!
>
> Alison Berman, MFS
> Supervisor
> Quality Control - Microbiology
>
> [AMR_Logo_for Email Signatures_19DEC]
>
> O 631.924.4000 ext. 379
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Steris - http://www.sterislifesciences.com/

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

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

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

BD Industrial Media - http://www.bd.com/ds/

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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