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December 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:
Sat, 30 Nov 2019 09:24:53 -0500
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Dear Vijay,

I disagree with your post that you do not need to use all three strains for suitability testing.  USP Chapter 60 is about the absence of Burkholderia cepacia complex and not just Burkholderia cepacia in aqueous product formulations.  Besides, Eurofins  presented test data showing that B. multivorans and B. cenocepacia could not be detected until after 48 hours of incubation.  By using only B. cepacia ATCC 25416 for suitability testing, I would suspect that you may be opening yourself to a 483 citation if your testing is based upon USP Chapter 60.

Don

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

Sent from my iPhone

> On Nov 29, 2019, at 12:33 PM, Vijay Kishore <[log in to unmask]> wrote:
> 
> ´╗┐Hi,
> 
> For GPT, all 3 strains should be used and for suitability one strain 25416
> is sufficient.
> 
> 
> Thanks,
> Vijay.
> 
>> On Thu 28 Nov, 2019, 6:34 AM sam taba, <[log in to unmask]> wrote:
>> 
>> Dear Forum,
>> For Growth Promotion Test & Suitability would it be enough and acceptable
>> to use only one strains ( ATCC 25416 ) or  use of all  3 strains ( ATCC
>> 25416,BAA245, BAA247) is mandatory?
>> 
>> Thank you  in advance
>> 
>> Have  a great day
>> 
>> Sam.T
>> 
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> ------------------
> 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]
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> 
> 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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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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