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October 2019

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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 30 Sep 2019 19:35:08 -0400
Content-Type:
text/plain
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Dear Stephanie and Peter,

I had accidently missed the pH for BCSA in the supplement chapter.
However, the manufacturers are not consistent with their pH's for their
versions of BCSA at this time.

Don

On Mon, Sep 30, 2019 at 6:06 PM Stephanie Bernards <[log in to unmask]>
wrote:

> Hi Don,
>
> In reviewing the pending USP chapter <60>  I am seeing the pH range listed
> at 6.8 +/- 0.3.  I was wondering if you could please point me in the
> direction of the pH range you referenced below for further review.
>
> Thank you,
> Stephanie
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Donald English
> Sent: Saturday, September 28, 2019 4:47 PM
> To: [log in to unmask]
> Subject: [PMFLIST] BCSA Dehydrated Media Suppliers
>
> Dear all,
>
> After December 1st, USP Chapter 60 – Microbiological Examination of
> Nonsterile Products-Tests for Burkholderia cepacia complex becomes
> effective for the testing of aqueous products.  In an internet search, I do
> find suppliers offering prepared sterile plates of Burkholderia cepacia
> Selective Agar.  However, I’m seeing that some of these suppliers have
> different pH’s for this selective/differential agar from what is
> recommended in USP Chapter 60.  For example, the pH of this agar in the USP
> is listed as 7.0 +/- 0.1 while I have found 2 suppliers to have a pH of 6.8
> +/- 0.3 and 7.2 +/-0.2.  I only found one supplier that has the same
> +exact
> pH of this medium as 7.0 +/- 0.1.  In addition, I have found one supplier
> of this agar with a different composition from what is listed in USP
> Chapter 60.  If you are going to be purchasing prepared plates of BCSA for
> usage in microbial testing, you will need to confirm that the agar
> composition and pH are in compliance with USP Chapter 60 requirements.
>
> However, I have a client that is interested in purchasing containers of
> BCSA dehydrated media for reconstitution, but I’m finding no suppliers of
> this dehydrated media.  Does anyone have a supplier of Burkholderia cepacia
> Selective Agar dehydrated powder?
>
> In looking at the composition of Burkholderia cepacia Selective Agar, I
> see that it includes the following antibiotics: Gentamicin, Vancomycin and
> Polymyxin B.  According to Traub and Leonhard (Reference: Traub, W.H. and
> Leonhard, B. Heat Stability of the antimicrobial activity of sixty-two
> antibacterial agents. Journal of Antimicrobial Chemotherapy (1995) 35,
> 149-154).  According to this article, the antimicrobial stability of
> Gentamicin and Vancomycin are heat stable at 121C for 15 minutes.  However,
> Polymyxin B was found only to be partially heat-stable because heat raised
> the MIC’s of this antibiotic four to eight fold when heated at 121C in
> comparison to RT and 56C.
>
>  I’m wondering whether a dehydrated media supplier for this agar is not
> currently available because a supplement containing Polymyxin B is not
> available like tellurite solution needs to be added to Vogel-Johnson Agar.
>
> Don
>
> Donald J. English Microbiological Quality Consulting LLC
>
> Florham Park, New Jersey 07932
>
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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
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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.

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