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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
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Fri, 4 Oct 2019 16:07:39 -0400
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Chad, What were the commercially prepared strains used in the study? 



Sent from my iPhone
> On Oct 4, 2019, at 1:10 PM, WILKEY Chad <[log in to unmask]> wrote:
> 
> Robert,
> 
> There was a poster presented at the 2011 PDA Pharmaceutical Microbiology Conference entitled, "Evaluation of Commercially Prepared Microbial Cultures for Use in Performing USP <51> Antimicrobial Effectiveness Testing" that makes the comparison to determine if commercially prepared strains yield the same results as freshly prepared cultures.  The results did show that there were no change in outcome  of the results.
> 
> 
> Chad Wilkey
> bioMérieux | Sr. Solutions Manager Healthcare
> [log in to unmask]
> Tel: (314) 731 - 8556 | Mobile: (314) 910 - 7146
> www.biomerieux-usa.com
> 
> 
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Knutsen, Chris
> Sent: Friday, October 4, 2019 7:23 AM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] USP <51> AET Cultures - Fresh vs Premade
> 
> External Email
> 
> Robert,
> Would that any contract lab could make the right suspensions. I had, for a contractor that I was  involved with in years past that didn't know how to do this. I had to introduce them to the world of McFarland Standards and also sent them directions on how to "develop" a photometric way to estimate the concentrations of the bugs.
> 
> 
> Chris Knutsen, Ph.D.
> Technical Fellow
> ASO Microbiology Center of Excellence
> Bristol-Myers Squibb Company
> 1 Squibb Drive
> New Brunswick, NJ 08902
> Tel : +1-732-227-5375
> Fax: +1-732-227-3071
> Cell: +1-609-751-8362
> e-mail: [log in to unmask]
> 
> 
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Robert Pritchett
> Sent: Tuesday, October 1, 2019 3:38 PM
> To: [log in to unmask]
> Subject: [PMFLIST] USP <51> AET Cultures - Fresh vs Premade
> 
> [Use CAUTION when opening links/attachments]
> 
> Hello all,
> 
> USP <51> AET has the following text regarding preparation of test strains:
> 
> "Use standardized suspensions of test strains or prepare as stated below."
> "The viable microorganisms used in the procedure should be part of a freshly growing culture (e.g., in logarithmic growth phase) with the exception of A. brasiliensis spores."
> 
> I've encountered at least one contract lab who uses pre-made commercially available lyophilized cultures specifically marketed for AET. The lyophilized cultures are hydrated and then used for testing and that lab tells me they consider this the mentioned "standardized suspensions" from the USP text. The contract laboratory does perform proper method suitability using the premade AET cultures with passing results and I have seen the validation work for using AET pre-made cultures, but I still question the acceptability of the practice.
> 
> My personal opinions/talking points are as follows:
> - Why? It's simpler and more cost effective to start a fresh culture and any analyst with the title microbiologist should be able to adjust suspensions accordingly
> - Introducing recently desiccated, starved, frozen, and stressed cells as a challenge to a preservative system seems like a very bad idea - a weak preservative system might pass when it would otherwise fail when challenged with fresh cultures
> - The validation work cannot possibly represent the varied materials and preservative systems that may be tested for AET
> 
> At this time, I've requested laboratories performing AET for my site to always use fresh cultures.
> 
> With that said, I'm open to hear what others may say on the topic. Can anybody defend using pre-made commercial cultures for AET?
> 
> -RP
> 
> 
> 
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> Science Advisory Board https://www.scienceboard.net/
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> Steris - http://www.sterislifesciences.com/
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> Charles River Laboratories - http://www.criver.com/
> 
> Veltek Associates, Inc - http://www.sterile.com
> 
> Microbiologics, Inc. - http://www.microbiologics.com
> 
> BD Industrial Media - http://www.bd.com/ds/
> 
> Boston Analytical http://www.bostonanalytical.com/
> 
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
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The Microbiology Network (http://microbiologynetwork.com) and supported by
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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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Science Advisory Board https://www.scienceboard.net/

Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

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

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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