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May 2020

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Subject:
From:
Tina Kramer <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 7 May 2020 16:25:03 +0000
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Michelle,

We are having a similar experience with the appearance of these organisms on BCSA.  The statement in USP <60> regarding the presence of white colonies surrounded by a pink-red zone on BCSA is under the Interpretation heading in the Testing of Products section. Perhaps there are other members of the Bcc that produce white colonies on BCSA, but we are not seeing that with any of the three USP <60> ATCC test organisms.  

The growth promotion section of USP <60> states, "Colonies are comparable in appearance and indication reactions to those previously obtained with a previously tested and approved batch of medium."  Our approach was to observe the appearance of each test organism on BCSA and use those observations as the basis for normal appearance and indication reactions for growth promotion testing of all future lots of BCSA received.

Tina

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Michelle Raynes
Sent: Thursday, April 30, 2020 8:37 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

This message was sent from outside the company. Please do not click links or open attachments unless you recognize the source of this email or know the content is safe.

I was wondering if anyone knows if there are plans for USP <60> to include further information/clarification regarding the growth promotion in the Interpretation section?  Currently, the possible presence of Bcc is indicated by the growth of greenish-brown colonies with yellow halos or white colonies surrounded by a pink-red zone on BCSA.  We are finding the B.cepacia organism does have the greenish-brown colonies with yellow halos on BCSA, but we would not call the B. multivorans or the B. cenocepacia colonies white.  We are getting a pink/red zone, but not with white colonies.  Is anyone having a similar experience?

Freundliche Grüße / Best regards,

Michelle Raynes
QA 2

////////////////////

Bayer U.S. LLC
Commercial Operations, North America, Consumer Health QA Microbiology Laboratory
100 Bayer Road
Whippany, NJ
United States
Tel:      +1 717 866-3927
E-mail: [log in to unmask]
Web:    http://www.bayer.us


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Timothy Cser
Sent: Tuesday, April 21, 2020 1:59 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

Hi RK.  The chapter states "NLT 1g"...not less than one gram of product.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of [log in to unmask]
Sent: Monday, April 20, 2020 11:09 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

What's the specification of Bcc in product/ water sample?
Should be absent in 10g (or) 10ml of sample?

Thanks and Regards
RK Reddy

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of WAGER Renee
Sent: 20 April 2020 22:11
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

Do you also perform this testing routinely on your water systems?

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Timothy Cser
Sent: Monday, April 20, 2020 12:17 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

Hi Dennis.  The 5 organisms in the chart should be used for GP and Suitability testing.  I believe the "or" is a mistake in the chapter and perhaps Tony Cundell can confirm that.

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Dennis Neeson
Sent: Monday, April 20, 2020 7:33 AM
To: [log in to unmask]
Subject: [PMFLIST] USP <60> Question

All,

USP Chapter <60>  on testing for B. cepacia references three (3) different strains of Burkholderia for Growth promotion and Suitability testing. Are your labs using all 3 of these strains each time you perform these tests (GP & Suitability) or do you select only one , such as the hardest to recover?

Thank you

--

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Steris - http://www.sterislifesciences.com/

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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/

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


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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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

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

BD Industrial Media - http://www.bd.com/ds/

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


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