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March 2012

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Fri, 2 Mar 2012 09:00:32 -0500
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Bryon:
I  could not have said this better. It is the explanation that is provided by my staff whenever someone comes to us with the idea to save money by stopping the growth promotion.  These are important points to consider.

For Jessica:
One possible solution is to get a contract lab to perform that GP for you.  You can contact the various media suppliers.  Some are now offering media with longer shelf lives, so you can have the media delivered less frequently and thus, save some money on the GP costs.

Chris Knutsen, Ph.D.
Associate Director, Microbiology
ABD
Bristol-Myers Squibb Company
1 Squibb Drive
New Brunswick, NJ 08902
Tel : +1-732-227-5375
Fax: +1-732-227-3071
e-mail: [log in to unmask]



>-----Original Message-----
>From: The Pharmaceutical Microbiology Forum Email List
>[mailto:[log in to unmask]] On Behalf Of Byron Lewis
>Sent: Thursday, March 01, 2012 5:51 PM
>To: [log in to unmask]
>Subject: Re: [PMFLIST] Growth Promotion Requirements
>
>Jessica,
>
>You need to be able to address two issues before you accept media based on a
>certification.
>
>1. Does the quality system which generates the certification meet all
>requirements? Vendor audits would be one basis for accepting certifications,
>but that will likely cost you more than doing your own growth promotion
>testing.
>
>2. What are the potential adverse effects of shipping on the media? Often
>media is not shipped under the best of conditions, such as not making sure
>it stays at refrigeration temperatures during transit. Unless you purchase
>the media from a near by vendor, I would not ignore the potential effects of
>shipping.
>
>There are vendors that sell the growth promotion cultures in a ready to use
>form. I suggest getting one of them on your approved vendors list and doing
>your own growth promotion testing. The media will rarely fail, but it
>removes potential quality questions.
>
>Regards,
>Byron Lewis
>
>
>
>--- On Wed, 2/29/12, Jessica Wentzel <[log in to unmask]> wrote:
>
>
>From: Jessica Wentzel <[log in to unmask]>
>Subject: [PMFLIST] Growth Promotion Requirements
>To: [log in to unmask]
>Date: Wednesday, February 29, 2012, 2:20 PM
>
>
>I'm looking for some guidance on the USP requirement for growth
>promotion of media.  I work for a medical device company (non-sterile
>manufacturing) and I use TSA and SDA RODACS and RCS strips for
>environmental monitoring.  My lab is very new and I do not have the
>capability to perform GP yet.  The vendor of the media performs GP
>prior to releasing it to customers.  I have written in to our
>procedures to confirm that this testing is passing and we obtain
>CofA's for all media used.  Is this enough?  Or am I not in compliance
>by not performing GP myself?
>
>Thanks!
>
>Jessica
>
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>=================================
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>------------------
>The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
>The Microbiology Network (http://microbiol.org) and supported by
>our sponsors (http://microbiol.org/sponsor.htm) 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.
>
>Accugenix - http://www.accugenix.com
>
>American Type Culture Collection - http://www.atcc.org
>
>BD Diagnostic Systems - http://www.bd.com/ds/
>
>Biolog - http://www.biolog.com
>
>Biomerieux - http://industry.biomerieux-usa.com
>
>Biotest - http://www.BiotestUSA.com/micro
>
>Lonza Rapid Testing Solutions - http://www.lonza.com/rts
>
>MicroBioLogics, Inc. - http://www.microbiologics.com
>
>Pall - http://www.pall.com
>
>NovaTek International - http://www.ntint.com
>
>Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>
>Steris - http://www.sterislifesciences.com/
>
>Veltek Associates, Inc - http://www.sterile.com
>
>=================================
>The nature of this service is to provide a medium for communication.  The
>specific statements and endorsements of individuals participating in the
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------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Biotest - http://www.BiotestUSA.com/micro

Lonza Rapid Testing Solutions - http://www.lonza.com/rts

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

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

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