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March 2012

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Subject:
From:
Jessica Wentzel <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 6 Mar 2012 08:17:20 -0700
Content-Type:
text/plain
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text/plain (338 lines)
Thanks everyone for your feedback!

Just to clarify...  my lab is very recently constructed and I don't
have qualified equipment to use just yet.  I am in the process of
qualifying my incubators and at that point I'll be able to perform GP
in house.  I have always planned on doing this testing once my lab is
ready, but I was concerned in the meantime.

The vendor I use for media is on our approved supplier list (audited)
and they perform GP testing per USP and EP and list all the organisms
used, incubation parameters, and results.

I know it's not ideal to not be doing GP yet, but in the next few
weeks I will be.

Thanks again!

On 3/5/12, Steven G. Richter <[log in to unmask]> wrote:
> Jessica,
>
> I would audit the media manufacturer.  Once audited, then you may want to
> send out the GPT to an outside lab to confirm quality and stability.  You
> should set up some type of a stability program based upon your storage
> requirements and shelf life.
>
> Steven G. Richter, Ph.D
> President & CEO
> Microtest Labs
> Tel: 413-786-1680 ext. 122
> Fax: 413-789-4334
> www.microtestlabs.com
>
>
>
>
>
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> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List
> [mailto:[log in to unmask]] On Behalf Of Knutsen, Chris
> Sent: Friday, March 02, 2012 9:01 AM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Growth Promotion Requirements
>
> 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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>>
>>Biotest - http://www.BiotestUSA.com/micro
>>
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>>
>>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.
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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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> 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.
>
> ------------------
> 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.
>

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