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Subject:
From:
Joel Russo <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 11 Mar 2020 23:50:22 -0400
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Use one temperature that will not damage spores, yet will allow human bourne organisms to be detectable in a vial after 14 days.  EM samples should be incubated similarly in my opinion.  Qualify it.

Kind Regards,
Joel

> On Mar 6, 2020, at 8:53 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
> 
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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and 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.
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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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