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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:
Fri, 9 Mar 2012 08:38:11 -0700
Content-Type:
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Hi Byron,

I am not yet using my incubators for environmental monitoring
incubation.  I have my samples incubated at a contract lab.  I'm in
the process right now of qualifying all the incubators and
refrigerators in my lab.

In a few weeks I'll be able to incubate samples in house, store growth
promotion cultures, and perform growth promotion on my media.  All my
questions have just been in preparation.  Thanks!

On 3/7/12, Byron Lewis <[log in to unmask]> wrote:
> Jessica,
>
> The e-mail string went over the maximum size, so I am going back to your
> orginal message.
>
> I would contend that until your equipment is qualified (such as your
> incubators) you should not be using them for your environmental monitoring.
> What if they fail qualification? Your results will all be in question. This
> is a bigger quality issue than not performing growth promotion on your
> media.
>
> When you start receiving growth promotion cultures, you should at least
> confirm the counts for cultures that are sent ready to use in growth
> promotion testing (for one thing you don't want to have issues come up while
> you are trying to qualify your media later). I would accept the id as per
> the certification, but at least confirm it by Gram Stain. If you start
> preparing your own growth promotion cultures from stock cultures, I would
> use the ATTC strains listed in USP as a starting point and I would also
> confirm them by identification.
>
> 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
> 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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