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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:
Mon, 15 Jun 2020 11:33:26 -0400
Content-Type:
text/plain
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text/plain (221 lines)
Dave,

Using an official method for Total Aerobic Microbial Count found in USP
<61> that meets the method suitability requirements for bioburden
monitoring  would not be considered an alternative method subjected to
method validation as described in USP <1223>.

Since the NECC fungal outbreak regulators and industry alike have been more
sensitive to fungal contamination but requiring the use of SDA for routine
downstream bioburden monitoring based on the potential fungal risk is not
useful.

Tony

On Mon, Jun 15, 2020 at 10:30 AM Dave Houde <[log in to unmask]> wrote:

> 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
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> the
> > > discussions are not necessarily those of the PMF or the sponsors of 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.
>


-- 
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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