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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 15 Jul 2020 15:31:56 -0400
Content-Type:
text/plain
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text/plain (96 lines)
   -

   The 2004 FDA Aseptic Processing Guidance states:

   Incubation temperature should be suitable for recovery of bioburden and
   environmental isolates and should at no time be outside the range of 20-35
   oC. Incubation temperature should be maintained within +2.5oC of the
   target temperature.
   -

   Incubation time should not be less than 14 days. If two temperatures are
   used for the incubation of the media filled units, the units should be
   incubated for at least 7 days at each temperature (starting with the lower
   temperature).

   Tony


On Thu, Jul 9, 2020 at 9:51 AM Reuven Baum <[log in to unmask]> wrote:

> We previously incubated media fills at 20-25C for 14 days.
> We intend to change to 20-25C for 7 days followed by 30-35C for 7 days.
>
> What level of justification is needed for this change ?
> Is a risk assessment enough ?
> Do we need to do a study with microorganisms  ?
>
>
> Reuven
> QC Microbiologist
> Isotopia
>
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> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
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> Veltek Associates, Inc - http://www.sterile.com
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> Microbiologics, Inc. - http://www.microbiologics.com
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
The PMFList is supported by our sponsors as a service to the scientific community.

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]



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

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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/


=================================
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 PMF or the sponsors of the list.

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