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March 2012

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Subject:
From:
Jeff S One <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 27 Mar 2012 12:15:57 -0500
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Hi Heather,

You can make a case for worst case load pattern for media.  First 
determine heat penetration by looking at how long it takes for various 
containers of different size and composition to come to temp.  Create a 
matrix and document this. This can be done with thermo couples.  For 
example, stainless steel heats up faster than glass.  Then looking at 
media there may be a trade off between media fill sized vs. size of the 
container.  In other words you cannot just assume the highest fill volume 
has the longest heat penetration.  A smaller fill size may have a 
container with thicker glass that may take longer to come to temperature. 
Once this is all determined you can load your autoclave with the worst 
case configuration of media and challenge with BIs and thermocouples.

Sincerely,
Jeff One













From:
Heather McCormick <[log in to unmask]>
To:
[log in to unmask]
Date:
03/27/2012 11:53 AM
Subject:
[PMFLIST] Autoclave Load Patterns
Sent by:
The Pharmaceutical Microbiology Forum Email List 
<[log in to unmask]>



Hi there,

We are a contract laboratory, and we prepare, sterilize, and 
growth-promote
the majority of the agar and broth media that we use to test our clients'
products.  The contents of our autoclave loads can vary quite 
significantly,
depending on what types of analyses we have in-house/ what type of media 
we
require on a given day.

Based on the above, it is not realistic for us to specifically qualify 
every
possible load pattern that we may use.  In our annual autoclave
re-qualifications, we typically validate our liquid cycle for a couple
configurations of maximum (chamber packed with large volumes of agar 
media)
and minimum (chamber containing small volumes of broth media) loads.  We
include thermocouples and BI ampoules in the loads, and test media for
growth promotion post-sterilization.

We believe this validation study qualifies all media load patterns that we
run, as long as they contain volumes of media within the validated range. 
I
am just wondering if this sounds reasonable to the PMF, as we have 
recently
had to defend this approach.

Please offer any opinions you may have on the subject, and industry
references/ guidelines that may be helpful.

Thanks so much


Heather McCormick

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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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