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December 2019

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From:
Alan Whipple <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 2 Dec 2019 09:07:37 +0000
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My interpretation of USP <60> seems at odds with most others...but I think I have interpreted the subtleties of the text correctly.  I am applying the rules of English to this problem rather than science.

USP <60> for growth promotion, in table 2, indicates that we should use "Burkholderia cepacia, Burkholderia cenocepacia or Burholderia multivorans".  Since the word "or" is used and not "and", I presume that means we are only required to use one of the 3 microorganisms.

For suitability testing I agree with the majority of comments...Here the USP chapter seems to suggest the use of all 3 BCC species.  I draw that conclusion from the use of the word "each" in the following text:
"For each new product to be tested, perform the sample preparation as described in Testing of Products. At the time of mixing, add each test strain in the prescribed growth medium."

Regards

Alan Whipple
Microbiology Director (AS&T)
Consumer Healthcare
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GSK
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-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Donald English
Sent: 30 November 2019 14:25
To: [log in to unmask]
Subject: Re: [PMFLIST] USP 60 strains

EXTERNAL

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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Microbiologics, Inc. - http://www.microbiologics.com

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

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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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