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October 2019

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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:
Wed, 30 Oct 2019 21:23:01 -0400
Content-Type:
text/plain
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text/plain (135 lines)
Dear Carly,

Clostridium testing in USP Chapter 62 is not required to be performed for
all liquid non-sterile product formulations.  I believe that the only USP
monograph that has a specification for the absence of Clostridium species
is Honey that is used in preparations for infants less than 1 year in age,
but you might need to confirm if there are other ingredient monographs
requiring this testing.

However, I have seen companies perform Clostridium testing by using USP
Chapter 62 on earth derived raw ingredients such as talc, diatomaceous
earth and naturals clays because Clostridium spores may reside in these
materials.

However, I have never seen people perform Clostridium testing on a drug,
dietary supplement or cosmetic finished product formulation.  If a finished
product formulation contains an earth derived raw ingredient that could be
contaminated with Clostridria, it is generally more cost effective to
perform Clostridium testing on raw material instead before they are used as
part of the raw ingredients that are present in a finished product
formulation.  It is cheaper to discard a raw ingredient that is
contaminated with Clostridium and replace it with a lot that is not
contaminated instead of a package finished product formulation.  In
addition, I have also seen companies either remedial treat or obtain
treated earth derived raw ingredients by using gamma irradiation .  It
should be noted that gamma irradiation can not be used on all earth derived
raw ingredients due to issues such as changes that are produced in color
and/or viscosity.

Regards,
Don

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

On Wed, Oct 30, 2019 at 12:03 AM Bromell, Carly <[log in to unmask]>
wrote:

> Hello All,
>
> Is there a group consensus for which types of products need to be tested
> for Clostridium per USP <62> and <2022>?  I was told all liquids because of
> C. botulinum, but FDA BAM (I know it's not USP) was more concerned with C.
> perfringens in dehydrated soups, sauces and spices.  Any guidance on which
> products have a higher risk for Clostridium and should be tested regularly
> would be really appreciated.
>
> Thanks so much,
> ________________________________
> Carly Bromell
> Manager, QC Microbiology
> (253) 853-7333 Office
> [http://bap.metagenics.com/metalogo.png]<http://www.metagenics.com>
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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]



Science Advisory Board https://www.scienceboard.net/

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/

Boston Analytical http://www.bostonanalytical.com/

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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