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Subject:
From:
"Sattelberg, Nicholas" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 8 May 2020 14:01:12 +0000
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It's also worth nothing that <60> states: "Any growth on BCSA is confirmed by identification tests".

Because the differential properties are not very good, we simply record any colonies as "growth", and then report absence/presences once isolates have been ID'd.

Nick Sattelberg
Group Leader, Microbiology


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Donald English
Sent: Friday, May 8, 2020 4:09 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <60> Question

CAUTION:  This email originated from outside the organization.
Do not click or open attachments unless you recognize the sender.

Dear Tina and Michelle,

In USP Chapter 60, it states that the 3 Burkholderia strains should be growth promoting and indicative on BCSA.  However, there is nothing in this chapter that states what should be the indicative reaction for each of these strains on BCSA.

If you look at the product informational sheets for BCSA from different suppliers, they only use Burkholderia cepacia ATCC 25416 as their growth promoting test organism.  I have not seen any media manufacturer data indicating what would be the appearance of Burkholderia cenocepacia and Burkholderia multivorans on BCSA.  However, I have also seen media manufacturer literature that says that Burkholderia cepacia complex colonies will appear as either white colonies surrounded by a pink-reddish zone or greenish-brown colonies with a yellow zone on BCSA.  Because it is very difficult to separate the members of Burkholderia cepacia complex by biochemical means, you may need to have use this either/or appearance of colonies on BCSA.  For this reason, I believe that it was assumed by the USP that the growth of Burkholderia cenocepacia and Burkholderia multivorans on BCSA will appear the same as Burkholderia cepacia ATCC 25416 .

It is best to use the guidance in the USP Chapter to base the indicative reactions for each of the 3 strains of Burkholderia in how they appeared on a previous batch of BCSA as your indicative properties.

This problem in the appearance of Burkholderia cenocepacia and Burkholderia multivorans on BCSA is a good reason for not using colony appearance on a selective/differential agars as a presumptive identification of an isolate.  When it comes to identification of microbial isolates, it is time to move into the 21st century to use the technology that is available today and do away with presumptive identifications of isolates. It would be great if the Star-Trek Tricoder would be available to do identifications of microbial isolates.

Regards,
Don

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




On Thu, May 7, 2020 at 7:52 PM Tina Kramer <[log in to unmask]> wrote:

> 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
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>
> -----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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Veltek Associates, Inc - https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterile.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7C58373b42cce24ab3f6ab08d7f3574986%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637245428538498250&amp;sdata=db6e31d1tIig1k2EdhfFeROIagwey%2FyvJOCxlyQgaS4%3D&amp;reserved=0

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BD Industrial Media - https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bd.com%2Fds%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7C58373b42cce24ab3f6ab08d7f3574986%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637245428538498250&amp;sdata=oyKIi4igBuf63SaaCogXx38b5rZ5vJvBmXhJzEkCX3A%3D&amp;reserved=0

Associates of Cape Cod, Inc. - https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.acciusa.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7C58373b42cce24ab3f6ab08d7f3574986%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637245428538498250&amp;sdata=JiirMzAEZr3%2BSAlXunT9F2fOq%2F5yc%2FGdFEW5aWsJO7Q%3D&amp;reserved=0


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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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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 PMF or the sponsors of the list.

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