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March 2012

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Subject:
From:
Eddington Don <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 27 Mar 2012 13:57:45 -0400
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Hi Chris

Decontaminated is the better term to use because there are usually some occluded surfaces that are not exposed to VHP. For example, tri clamp connections or small test equipment may be inside the isolator which will create places for microbes to hide. This is not an issue is these things are not disassembled after VHP. 

For aseptic filling applications, any product contact surface such as a stopper bowl should be validated to at least a 6 spore log reduction but I would still refer to this as decontamination in protocols. 

Best regards

Don Eddington
METALL + PLASTIC

Sent from my iPhone

On Mar 27, 2012, at 12:51 PM, "Knutsen, Chris" <[log in to unmask]> wrote:

> It may be splitting hairs, but would an isolator that had undergone a validated VHP cycle be expected to be sterile or decontaminated?
> 
> Chris Knutsen, Ph.D.
> Associate Director, Microbiology
> ABD
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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

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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.

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