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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, 23 Nov 2019 20:38:51 -0500
Content-Type:
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Dear Azeb,

At the present time, USP Chapter 60 does not apply to dietary supplements.  In my experience in conducting microbial limits testing on dietary supplements, I have not detected the presence of Burkholderia cepacia complex in them.  Most dietary supplement formulations are either capsule or tablet formulations in which it would be highly unusual to detect the presence of this  microbial species.  However, I have seen a few aqueous dietary supplement product formulations, but no Burkholderia cepacia complex contamination or even Pseudomonas contamination was ever detected.  At this time, I do not have an explanation for their absence in aqueous dietary supplement formulations, but maybe the reason is the limited number of aqueous product formulations in comparison to the number of  capsules/tablet formulations.  When I was setting microbial test specifications for aqueous dietary supplement product formulations, I would include the absence of Pseudomonas species due to possible harmful product esthetics that could form due to their presence.  For aqueous dietary supplements, I have no objections to test for the presence of Burkholderia cepacia complex for the same reasons as conducting testing for the presence of Pseudomonas.

Regards,
Don

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

Sent from my iPhone

> On Nov 21, 2019, at 3:31 PM, Azeb Amsalu <[log in to unmask]> wrote:
> 
> Dear Don,
> 
> Do we have to test liquid dietary supplements (juice) for presence of B. cepacia complex?
> 
> Thanks,
> Azeb Amsalu
> Microbiology Lab Manager
> Office: 214-355-5434
> [log in to unmask]
> 
> 13745 Jupiter Road
> Dallas, Tx  75238
> PLEASE CONSIDER THE ENVIRONMENT BEFORE PRINTING THIS E-MAIL!
> This message may contain confidential and/or privileged information. If you are not the addressee or authorized to receive this for the addressee, you must not use, copy, disclose or take any action based on this message or any information herein. If you have received this message in error, please advise the sender immediately by reply e-mail and delete this message. Thank you for your cooperation.
> 
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Donald English
> Sent: Wednesday, September 25, 2019 1:25 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] USP (60) TESTS FOR BURKHOLDERIA CEPACIA COMPLEX
> 
> Dear Peter.
> 
> I would consider an oil-in-water emulsion as an aqueous product formulation that will need to be tested for presence or absence of Burkholderia cepacia complex.
> 
> Don
> 
> Donald J. English Microbiological Quality Consulting LLC Florham Park, New Jersey 07932.
> 
> Sent from my iPhone
> 
>> On Sep 25, 2019, at 12:17 AM, Vad Péter <[log in to unmask]> wrote:
>> 
>> Dear Forum Members,
>> Do I have to test and evaluate a vaginal cream for Burkholderia cepacia complex according to USP <60>? The vaginal cream is an oil in water emulsion preparation.
>> Should be carry out a risk analysis (water activity etc)?
>> Thank you in advance
>> 
>> Peter Vad
>> microbiologist
>> Microbiological & Hygienic Laboratory, Dorog
>> 
>> 
>> 
>> 
>> Fővárosi Törvényszék Cégbírósága Cg. 01-10-040944
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>> Microbiologics, Inc. - 
>> https://us-west-2.protection.sophos.com?d=microbiologics.com&u=aHR0cDo
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>> =048b231a95194d8abe5439027655dc2f&t=c3FESURWVDFyakhkLy8xbEZaUkQrYzJZdn
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>> 0=
>> 
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>> https://us-west-2.protection.sophos.com?d=bostonanalytical.com&u=aHR0c
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>> L3cxT2ZKS1Vhd3ZseGR5b0ZNd3RTOD0=
>> 
>> Associates of Cape Cod, Inc. - 
>> https://us-west-2.protection.sophos.com?d=acciusa.com&u=aHR0cDovL3d3dy
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>> 8abe5439027655dc2f&t=MXNRcDIyZmNmOHVoMG9sYVhNMFcra2VPRkFwNk81bFdTWWV3N
>> DRqakc5WT0=
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>> 
>> =================================
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> 
> ------------------
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> 
> Veltek Associates, Inc - https://us-west-2.protection.sophos.com?d=sterile.com&u=aHR0cDovL3d3dy5zdGVyaWxlLmNvbQ==&e=YWFtc2FsdUBhdm9hLWRhbGxhcy5jb20=&h=048b231a95194d8abe5439027655dc2f&t=RFltcmtHK2czSzJTS2dyT2liTit6NFhEUCsrUm1Rc3l0NzhIbnRrb2gzYz0=
> 
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> 
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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.
> 
> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> 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/
> 
> 
> =================================
> 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.

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and 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]



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/


=================================
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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