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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sat, 7 Mar 2020 12:21:47 -0500
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Dear Sherie,

After reading the section of USP Chapter 61 called Recovery of Microorganisms  in the Presence of of Product,  it states that 1 gram or ml can be used for membrane filtration if you expect high numbers of microorganisms to be present.  In sample preparation for water soluble and non-soluble products, it does states that a 1:10 dilution should be used.  In the section, the amount of sample to be tested is 10 grams or ml’s in which this sample amount is diluted in 90 ml’s of diluent.  If you are conducting membrane filtration of a test sample that contains a high number of microorganisms, I interpreted this read to say that  a 1 gram or ml sample aliquot can be used instead.  In most cases, I would expect that low levels of microorganisms would be present in a test sample.  In addition, I would say that membrane filtration could be used on only those water soluble samples in which there were issues in neutralization of the preservative system by conducting a plate count method.

Regards,
Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932

Sent from my iPhone

> On Mar 6, 2020, at 3:56 PM, Sherie Poulson-Cook <[log in to unmask]> wrote:
> 
> Question for the collective:
> 
> In our micro lab we are trying to validate a TVC method for a liquid per 
> USP 61. USP 61 specifies under the recovery of microorganisms section for 
> membrane filtration that the material filtered should represent 1 g of the 
> product. However, under the "Amount Used for the Test" section it sates 
> that "unless otherwise directed, use 10 g or 10 mL of the product to be 
> examined."   Would we be justified in only filtering 1 mL of product per 
> the first statement? \
> 
> Regards,
> Sherie
> 
> 
> Sherie Poulson-Cook
> 
> 
> 
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The Microbiology Network (http://microbiologynetwork.com) and supported by
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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 - 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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