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Fri, 26 May 2006 07:22:02 +1200
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Stephanie
A sensitivity of <10/100ml is a big ask. My first response is ti suggest
filtration but I guess you have already considered that option and maybe
the material is not filterable.
In order to report a result of org/g we employ a dilution of 1:10 and plate
5 x 2ml volumes. For  a product that may require a dilution of 1:20 you
would plate 5 x 4ml volumes. Beyond that the logistics of sample size on
the plate gets difficult. By increasing the number of plates you will be
able to increase your sensitivity. How big did you say your incubator was?
(!)

My understanding (here anyway) was that bioburden usually refers to an
environmental test (surface etc) and MLT is generally for materials.
Brendan


                                                                       
             Stephanie Thomas                                          
             <stephanie_thomas                                         
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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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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

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