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November 2013

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Wed, 13 Nov 2013 23:12:30 -0600
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Hi Shelley,
One aspect of the in vitro efficacy test using coupons is the target log reduction of your isolates; most people use the guidelines in USP <1072> which target at least 2 log reduction for spore formers (mold or bacteria) and 3 log reduction for vegetative bacteria.  One must also consider potential loss of viability due to drying on the surface.  Your control recovery rate should be >70% of what was inoculated on to the surface (per USP <1227>).  Lastly, regulatory inspectors will want to see data generated using your in-house environmental isolates rather than strains from a culture collection.  While the latter may be included, it is not sufficient.

Please contact me directly for further information.
Best regards,
Marc
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________________________________________
From: The Pharmaceutical Microbiology Forum Email List [[log in to unmask]] On Behalf Of Hignett, Shelley [[log in to unmask]]
Sent: Friday, November 08, 2013 3:15 AM
To: [log in to unmask]
Subject: [PMFLIST] Disinfectant Validation

Hi,

I am wondering if someone can help. I am about to perform a coupon study for some new disinfectans. I would like to know if it is possible to use quanti-cults for the validation or do I require a more concentrated stock culture?

Kind Regards

Shelley Hignett
QC Analyst II Micro


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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.


Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Accugenix - http://www.accugenix.com

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

ATS Labs - http://www.ats-labs.com

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

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.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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