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From:
Karine Lebel <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 29 Oct 2019 10:07:09 -0400
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Dear Donald,

We have prepared suspensions of a fair number of Bcc strains starting from
overnight growth on TSA plates and then preparing a liquid suspension with
a concentration of 10-100 UFC / 10 uL. Some of these strains are from ATCC
and some are wild types, including both ATCC and wild type B. multivorans
and B. cenocepacia.

I could only speculate on the reasons of their relatively slow growth in
broths. We have not tested incubation with shaking.

Regards,

Karine

-----Message d'origine-----
De : The Pharmaceutical Microbiology Forum Email List <
[log in to unmask]> De la part de Donald English
Envoyé : 2019-10-23 15:04 À : [log in to unmask]
Objet : Re: [PMFLIST] USP Chapter 60 Revision Questions

Dear Karina,

Thank you for your response.  I’m assuming that your Bcc isolates are
wild-type strains in comparison to ATCC pedigree strains.  Is this correct?
I do not think that it would matter.  By your work, it looks like that you
are obtaining a sufficient population of these 2 strains by growing them on
TSA slants with an incubation period of 18 to 24 hours.  I wonder if you
get the same type of population growth levels by using TSB broth to prepare
a 10 to 100 CFU inoculum.  If you are getting sufficient growth of B.
multivorans and B. cenocepacia at 18 to 24 hours on a TSA slant, I wonder
the reason that you cannot detect either of these organisms in an
enrichment broth until after a 48 hour incubation period is due to
non-exposure of Oxygen  to these 2 organisms in the enrichment broth that
is not shaken.  I wonder by shaking the enrichment broth for 24 hours that
you would be able to detect each of these Bcc organisms at 24 hours instead
of 48 hours of incubation without shaking.

Regards,
Don

Donald J. English Microbiological Quality Consulting LLC Florham Park, New
Jersey 07933


Sent from my iPhone

> On Oct 23, 2019, at 12:14 PM, Karine Lebel <[log in to unmask]> wrote:
>
> Hello Donald,

>
> You might have already found the answer to your question about growth
> promotion of media and validation of the test method for a sample. If
> not, I hope this can help. We have Bcc isolates in our lab that grow
> slowly in broths and then on BCSA (that supports the longer incubation
> times of the new version of USP 60). We keep them on TSA slants and
> when we need them for growth promotion of media and validation of the
> test method for a sample, we streak them on a TSA plate, incubate for
> 18-24 hours and we obtain enough growth in order to prepare a
> suspension of less than 100 cells per 10 uL.
>
> Best regards,
>
> Karine Lebel
>
>> On Monday, September 23, 2019, Tony Cundell <[log in to unmask]>
wrote:
>>
>> Don,
>>
>> As the comments and the data we obtained supported the increase in
>> incubation I believed that republishing the proposed chapter would be
>> an unjustifiable delay.
>>
>> Based on the experience of our stakeholder implementing and routinely
>> using the method we would consider future changes.
>>
>> Test for specific microorganisms need to be as selective as possible
>> so additional media was not included..
>>
>> Tony
>>
>> On Mon, Sep 23, 2019 at 8:47 AM Donald English <
>> [log in to unmask]>
>> wrote:
>>
>>> Dear Tony,
>>>
>>> Thank you for the update concerning USP Chapter 60.  Because the
>> incubation
>>> temperature for the pre-enrichment and BCSA had been increased from
>>> 18 to 24 hours to 48 to 72 hours, I was under the impression that
>> this
>>> would have been considered as a major change for the chapter which
>>> would have it be published again in the PF for additional review and
>>> comment instead of going directly to
>> a
>>> USP Supplement.
>>>
>>> I'm still in favor of this proposed chapter, but I would like to see
>>> the inclusion of MacConkey Agar as a selective microbial growth agar
>>> for Burkholderia cepacia complex as an alternative to BCSA just like
>>> either VJA, Baird Parker Agar or Mannitol Salt Agar can be used for
>>> isolation of S. aureus in USP Chapter 61.  The Eurofins data
>>> supports the usage of MacConkey Agar as an alternative to BCSA.  I
>>> have seen too many times in which media suppliers have problems in
>>> supplying a particular type of microbial selective/differential
>>> growth media for usage by customers.  I always like to have options
>>> in isolating organisms from pre-enrichments
>> in
>>> case a particular type of microbial growth agar is not available by
>>> manufacturers due to production problems.
>>>
>>> However, I still think that there is a flaw in this chapter in
>>> obtaining the necessary inoculum levels of B. cenocepacia ATCC BAA-245
and B.
>>> multivorans ATCC BAA-247 (e.g. 10 to 100 CFU) for performing both
>>> growth promotion of the pre-enrichment media and BCSA and for
>>> validation of the test method with test samples for these 2
>>> organisms due to their poor growth at less than a 48 hour incubation
>>> period. In the currently
>> approved
>>> USP 60 chapter, the incubation period for these 2 organisms for
>>> inoculum preparation is still listed as 18 to 24 hours.  The
>>> Eurofins webinar presentation had indicated that each of these 2
>>> organism could not be recovered until after using a 48 hour
>>> incubation period.  I do not see how using a
>> 18
>>> to 24 hour incubation period would be sufficient to obtain the
>>> necessary inoculation levels of these 2 organisms for usage in
>>> performing growth promotion of media and validation of the test
>>> method for a test sample especially that the incubation period for
>>> recovery in pre-enrichment and BCSA had been increased to 48 to 72
hours.
>>>
>>> Regards,
>>> Don
>>>
>>> Donald J. English Microbiological Quality Consulting LLC Florham
>>> Park, New Jersey 07932
>>>
>>>
>>>
>>> On Thu, Sep 19, 2019 at 6:01 PM Lucille Krieger <
>> [log in to unmask]
>>>>
>>> wrote:
>>>
>>>> Hello Jeanne,
>>>> Thank you for sharing this.  Would you be able to provide a link or
>>>> reference for the warning letter you mentioned?
>>>> Lucy Krieger
>>>>
>>>> From: The Pharmaceutical Microbiology Forum Email List <
>>>> [log in to unmask]> On Behalf Of Jeanne
>>>> Moldenhauer
>>>> Sent: Wednesday, September 18, 2019 9:31 AM
>>>> To: [log in to unmask]
>>>> Subject: Re: [PMFLIST] USP Chapter 60 Revision Questions
>>>>
>>>> This message originated from outside your organization
>>>>
>>>> FYI
>>>>
>>>> A presentation that Dr. Metcalfe gave at the micro meeting in
>>>> Berlin a couple of years ago indicated that B. multivorans could
>>>> also have a
>> delay
>>>> of up to 48 hrs prior to going into growth phase.
>>>>
>>>> A warning letter issued to a company in 2016 required them to have
>>>> a 48 hour hold time before initiating the microbial limits test.
>>>>
>>>> Jeanne Moldenhauer
>>>>
>>>> On Wed, Sep 18, 2019 at 9:06 AM Donald English <
>>>> [log in to unmask]<mailto:[log in to unmask]>>
>>>> wrote:
>>>>
>>>>> Dear all,
>>>>>
>>>>> When the proposed USP Chapter 60-Microbiological Examination of
>>>> Nonsterile
>>>>> Products - Tests for Burkholderia cepacia complex had been
>>>>> initially published in the Pharmacopeia Forum, test sample
>>>>> enrichment
>>> in
>>>>> Soybean-Casein Digest Broth was at 30-35 for 24-48 hours. An
>>>>> aliquot
>> of
>>>>> this enrichment broth
>>>>> is then subculture for isolation onto Burkholderia cepacia
>>>>> Selective
>>> Agar
>>>>> (BCSA) for 30-25C for 18-72 hours.
>>>>>
>>>>> In the Eurofins webinar presentation on Burkholderia cepcia
>>>>> complex
>>>> testing
>>>>> for non-sterile water based products, they had indicated that
>>>> preincubation
>>>>> of enrichment broth and incubation of BCSA had to be increased to
>>>>> a
>>>> minimum
>>>>> of 48 hours due to the non-recovery of the following Burkholderia
>>>> cepacian
>>>>> complex organisms by using a 18-24 hour incubation period: B.
>>> cenocepacia
>>>>> ATCC BAA-245 and B. multivorans ATCC BAA-247. I'm not surprised
>>>>> that nether of these 2 species of Burkholderia cepacia complex
>>>>> could be
>>>> detected
>>>>> by using a 18 to 24 hour incubation period since they are both
>>>>> slow growers.
>>>>>
>>>>> According to the Eurofins webinar presentation, they say that the
>>>>> incubation periods for pre-enrichment and BSCA had been increased
>>>>> to
>> 48
>>>>> hours and have been accepted by the USP Microbiology Subcommittee.
>>>>>
>>>>> My question to the group, did the Pharmacopeia Forum published a
>>> revision
>>>>> to this proposed USP Chapter with these changes in the incubation
>>> periods
>>>>> for pre-enrichment and BCSA? If so, I have not seen this revision
>>>>> of
>>> the
>>>>> proposed USP Chapter 60 on the Pharmacopeia Forum website. If this
>>>>> revision in the proposed USP Chapter 60 had indeed been published,
>>> could
>>>>> someone provide a link to this revised chapter.
>>>>>
>>>>> Thanks,
>>>>> Don
>>>>>
>>>>> Donald J. English Microbiological Quality Consulting LLC Florham
>>>>> Park, New Jersey 07932
>>>>>
>>>>> ------------------
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>>>
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>>
>>
>> --
>> Tony Cundell, Ph. D.
>> Consulting Microbiologist
>> Email: [log in to unmask]
>> Phone: 914 725-3947
>> Cell: 914 841-0074
>>
>> ------------------
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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/
>>
>>
>> =================================
>> The nature of this service is to provide a medium for communication.
>> The specific statements and endorsements of individuals participating
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>> 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.

------------------
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.

------------------
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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