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Subject:
From:
Karine Lebel <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 22 Oct 2019 22:29:14 -0400
Content-Type:
text/plain
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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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> > > =================================
> > > The nature of this service is to provide a medium for communication.
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> >
> > ------------------
> > The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated
> from
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> > for their support of this service.
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> > contact [log in to unmask]
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> >
> >
> > 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.
> >
>
>
> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
>
> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
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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/
>
>
> =================================
> 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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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/


=================================
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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