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June 2020

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Subject:
From:
Dave Houde <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 15 Jun 2020 09:07:54 -0400
Content-Type:
text/plain
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text/plain (152 lines)
Thank you for this information. This is very helpful. It seems that using
TSA alone to enumerate fungi as well as bacteria on samples with a very low
bacterial load makes it an acceptable practice based on the science. My
question is more regulatory than science based. If bioburden is performed
on a product with a very low bacterial load using TSA to enumerate both
bacteria and fungi, is it considered a compendial method, since the USP/EP
instruct to use SDA to enumerate fungi? I have seen cases where auditors
claim that the use of TSA alone is an alternative to the compendial method
which then requires a full validation per <1223> Validation of Alternative
Microbiological Methods.

On Tue, Jun 9, 2020 at 11:22 PM Tony Cundell <[log in to unmask]> wrote:

> Dave,
>
> USP General Test Methods like <61> are provided for referee testing of
> compendial articles, in this case microbial enumeration testing for
> non-sterile drug products and pharmaceutical ingredients with USP monograph
> requirements. When the test is referenced in a regulatory submission it
> becomes a release test.
>
> The Total Aerobic Microbial Count methodology may be used for in-process
> testing after meeting the USP method suitability requirements and the
> growth promotion testing of individual batches of soybean-casein digest
> agar. As the method suitability and growth promotion requirements both
> include the ability to quantitatively recover both yeast and mold it may be
> considered a general microbiological growth medium.
>
> The purpose of the Total Combined Yeast and Mold Count is to selectively
> enumerate fungi within a high background of bacteria. In fact, Sabouraud
> Dextrose Agar was originally developed to isolate dermatological fungal
> pathogens by using a medium with a high concentration of carbohydrate
> Dextrose at la ow pH to suppress the bacterial growth. As Bacillus spp. can
> grow on the medium, antibiotics are usually added to exclude these
> bacteria.
>
> In downstream processing of solutions of proteinous material often held at
> refrigeration temperature, the most typical microbiota are Gram-negative,
> oxidase positive bacteria not yeast or mold. Under these
> circumstances, soybean-casein
> digest agar has a long history of use for monitoring in-process bioburden.
>
> Tony Cundell
>
> On Tue, Jun 9, 2020 at 2:37 PM Dave Houde <[log in to unmask]> wrote:
>
> >  It is not an uncommon practice in the pharmaceutical/Biotech industry to
> > use just TSA  incubated at 30 -35 degrees for the enumeration of both
> > bacteria and fungi. I have seen this method verified in accordance with
> > <61> to ensure it is an acceptable practice for both bacteria and fungi.
> >
> > Since this practice does not follow the compendial method exactly, as it
> > does not use SDA for Fungi, is verification of the method sufficient? Or
> > does it need to be fully validated per <1223> as an alternative
> > Microbiological method?
> >
> > ------------------
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> >
> >
> >
> > 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
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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.
>

------------------
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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