How can I perform suitability? Is it the same like other pharmaceutical
products?
On Mon, May 15, 2023 at 7:21 PM Donald English <[log in to unmask]>
wrote:
> Dear Dhara,
>
> Probiotic products are usually classified as a nutritional product.
> Instead of using USP <62>, USP <2022> - Microbiological Procedures for
> Absence of Specified Microorganisms - Nutritional and Dietary
> Supplements needs to be used instead to determine the presence or
> absence of organisms in nutritional and dietary supplements such as
> Clostridium sp., E. coli, Salmonella species and S. aureus. The
> methodology for conducting enrichment testing by using USP <2022> is
> different from what is in USP <62>. This is due to the fact that
> there are 2 different USP subcommittees in which one is responsible
> for USP <61> and <62> chapters and the second one is responsible for
> USP <2021> and <2022> chapters. Testing for the presence or absence
> of Gram-negative bile-tolerant organisms is not present in USP <2022>.
> The methodology that is present in USP <2022> is very similar to what
> is present in some of the chapters that are present in the FDA BAM.
> Lactobacillus species are Gram-positive bacilli, but are
> bile-tolerant. Lactobacillus species are commonly used as a probiotic
> organism. Streaking an aliquot from the enrichment broth used in USP
> <2022> onto Violet Red Bile Agar can be used to detect the presence of
> bile-tolerant Gram-negative bacteria.
>
> From my experience, I have found that sometimes low levels of
> bile-tolerant Gram-negative organisms are normally present in some
> nutritional and dietary supplement products. I have the scars from
> upper management when I rejected the product for the presence of these
> Gram-negative bile-tolerant organisms.
>
> Don
>
> Donald J. English Microbiologica Quality Consulting LLC
> Florham Park, New Jersey 07932
>
>
>
> On Mon, May 15, 2023 at 5:01 PM Dhara Patel <[log in to unmask]> wrote:
> >
> > Hi,
> >
> > Members.
> >
> > How to perform microbial suitability testing for probiotic products. if
> the
> > product contains more than one species of probiotic microorganism and
> > performs the suitability test for E.coli, Salmonella, staphylococcus
> aureus
> > and enterobacteriaceae. Can I perform the suitability test the same as
> per
> > USP 62?
> > Please advise which guideline i have to follow.
> >
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> Current Sponsors:
>
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Novatek International https://ntint.com/
>
> Steris - http://www.sterislifesciences.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Special Process Services, LC -
> https://www.linkedin.com/in/joseph-connaghan-b663929
>
>
>
> =================================
> 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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The PMFList is supported by our sponsors as a service to the scientific community.
Please take a second to visit our sponsors' web sites. Let them know you saw them on our list and appreciate their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask] or by completing the sponsorship form here: https://bit.ly/3FsEVrW
Current Sponsors:
Associates of Cape Cod, Inc. - http://www.acciusa.com/
Microbiologics, Inc. - http://www.microbiologics.com
Novatek International https://ntint.com/
Steris - http://www.sterislifesciences.com/
Veltek Associates, Inc - http://www.sterile.com
Special Process Services, LC - https://www.linkedin.com/in/joseph-connaghan-b663929
=================================
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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