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May 2006

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From:
matilde soubes <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 26 May 2006 16:08:12 -0300
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Maybe you can change the specification to say Most Probable number of 
....microorganisms and so you can give a result in 100 ml by 
inoculating  three double strength culture media tubes with ten mL , three 
tubes of simple strength medium with 1mL and three simple strength culture 
media tubes with 0,1 mL of sample.  Of course the method must be validated 
with regard to inhibition of growth in tubes. There are published tables 
for such inoculating scheme.

At 12:10 p.m. 24/05/2006, you wrote:

>One of my friends wants to know if we can get a sensitivity of <10 cfu/100 
>mL using a 50 mL sample.Normally for a regular MLT test we use 10 gms or 
>10 ml into 90 mL buffer or media,  plate duplicate 1 ml aliquots. If no 
>growth, results are expressed as <10 per ml because 1:10 dilution was 
>used. But if we test 50 ml how can we get a result of <10/100 mL. This is 
>a CPMP requirement for bulk prior to aseptic filtration. Even if we do a 
>1:10, aliquot 25 ml each into 4 large petridishes, can we acieve this 
>result? Or can we extrapolate from a result of <1/10 ml?
>   Any suggestions? She said that this material is very expensive and that 
> the manufacturing operations can provide her only 50 ml maximum.
>   Final question. What is the difference between bioburden and microbial 
> limits test.  For MLT you do screen for indicator organisms by enriching 
> the media and you do Aerobic plate count plus Yeast and Mold count. For 
> Bioburden, you only look for Total Plate count. But why does some 
> material require only one test over the other?
>
>
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Prof. Matilde Soubes
Catedrática de Microbiología
Facultad de Química
Montevideo, Uruguay 


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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

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

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

Millipore - http://www.millipore.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Raven Biological Labs - http://www.ravenlabs.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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