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June 2020

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Subject:
From:
"Dr. Michael J. Miller" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 15 Jun 2020 10:36:39 -0400
Content-Type:
text/plain
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text/plain (341 lines)
You are correct. If a monograph chapter requires the use of TSA and SDA, and you want to only use TSA, then you would have to validate the new method using TSA is as good as the existing, pharmacopeia method. Michael  

 

From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Dave Houde <[log in to unmask]>
Reply-To: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date: Monday, June 15, 2020 at 10:29 AM
To: <[log in to unmask]>
Subject: Re: [PMFLIST] Bioburden testing

 

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/

> 

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> =================================

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--

Tony Cundell, Ph. D.

Consulting Microbiologist

Email: [log in to unmask]

Phone: 914 725-3947

Cell: 914 841-0074

 

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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.

 


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