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PMFLIST  December 2019

PMFLIST December 2019

Subject:

Re: USP 60 strains

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

Content-Type:

text/plain

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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
Global Functions

GSK
North Lonsdale Road, Ulverston, Cumbria, LA12 9DR, United Kingdom

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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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Veltek Associates, Inc - http://www.sterile.com

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

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

Associates of Cape Cod, Inc. - http://www.acciusa.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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