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July 2020

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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, 8 Jul 2020 10:33:37 -0400
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Joel you should be aware that the USP does not specifically address
in-process bioburden as USP <61> is provided as the microbial enumeration
test when there is a microbiological requirement in the USP monograph.

On Wed, Jul 8, 2020 at 10:18 AM Joel Russo <[log in to unmask]> wrote:

> Hello all,
>
> I’m trying to compile a list of requirements (either official or PDA
> publication) defining in-process Bioburden sampling / testing.   Are they
> monograph specific per product (and / or water type used in the process per
> 1231), or are there regulations / standards out there that I’m glossing
> over?
>
> Kind Regards,
> Joel Russo
>
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> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
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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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