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November 1998

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Subject:
From:
Jeanne Moldenhauer <[log in to unmask]>
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Date:
Mon, 16 Nov 1998 09:42:44 -0600
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Hi Tony:

Fujisawa published data, in response to an FDA deficiency about
incubation parameters.  The data showed that you got better recovery,
even of molds, at 30- 35 deg C.  Generally, you can get approval from
FDA on some submissions, if you have the validation comparison data in
the submission.

Jeanne Moldenhauer

Tony & Roz Cundell wrote:
>
> The options that appear to be endorsed by the FDA are 20-25 degree C for 14
> days or 20-25 degree C for 7 days followed by an additional 7 days at 30-35
> degree C.
>
> My preferance is to incubate at the higher temperature first to encourage
> the rapid growth of the population most likely to be contaminants in an
> aseptic processing area, i.e. bacteria derived from personnel, review the
> media fill lot for massive aseptic processing control or even inspect the
> containers prior to moving the lot to 20-25 degree C storage for a further 7
> days to allow for fungal growth.
>
> I have worked in microbiology lab where this incubation pattern is routinely
> used for environmental monitoring.
>
> I would like poll the group as to which incubation conditions you use.  Also
> I would like to hear the rationale for using the lower temperature first.
>
> Tony Cundell
> Wyeth-Ayerst
> [log in to unmask]
>
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