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October 2009

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From:
Fábio Pacheco <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 26 Oct 2009 16:28:11 -0700
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Dear J. R.
let me see if I can help you:
1. USP 32 <62>, on the topic about S. aureus, states that we need to use a "1:10 dilution of not less than 1 g of the product", what means that you can use 1 g of sample, but dilute it in 10 ml of diluent, not 100 ml. If you decide to use 1 g/10 ml, then you will use the 10 ml total to inoculate in TSB. Then, you'll be fine.

2. For Salmonella, it is required to inoculate10 g of sample. So, you'll need to use 10 g of sample, dilute it 1:10 and inoculate in TSB.

3. If you've already tried dilution, filtration and neutralization and yet you couldn't recover Salmonella, it can be assumed that your product possesses antimicrobial activity against Salmonella. The other pathogens still need to be tested.

In a nutshell, the ammount of product used for test is generally 10 g or 10 ml. Exceptions are listed on <61> Testing of Products - Amount used for the test. The volume of TSB does not need to be 100 ml and is determined by the results of the "Suitability of Test Method".

Hope I could help you somehow.

Fabio Pacheco,
Senior Microbiologist - São Paulo, BR.
http://microbiologyonlineblog.blogspot.com




________________________________
De: J.R. <[log in to unmask]>
Para: [log in to unmask]
Enviadas: Sáb, Outubro 24, 2009 12:57:29 PM
Assunto: [PMFLIST] USP <62> Sample Amounts

Hello Everyone,

I have a few questions:

1. In the USP <62>, the screenings state to prepare the sample per the
sample preparation in the USP <61>. Does this reference include the sample
amount requirements (10 grams) listed in the USP <61>? For example, can I
prepare the Staphylococcus screening with one gram of sample in 100
milliliters or do I have to use a 10 gram sample amount for the preparation
and remove the equivalent to one gram of sample and add it to 100mL?

2. When testing per the Salmonella screen, if the sample qualifies for a
reduced amount under the sample requirements in USP <61>, do I still have to
use 10 grams of sample? If not, how do I determine the amount of sample to
use?

3. And finally, another Salmonella screen question, if a sample will not
pass the Salmonella suitability (dilution, filtration and neutralization
have been exhausted), can the sample amount be reduced from the 10 grams
required if Salmonella is recovered with one gram?  Or should the Salmonella
routine testing be performed with the 10 grams, at the highest dilution,
assuming the organism's antimicrobial properties won't allow growth?

Thanks,

J.R.

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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

Applied Biosystems, MicroSeq Microbial ID System - http://www.microseq.com/

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

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

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

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

Millipore - http://www.millipore.com

MODA Technology Partners - http://www.modatp.com

Pall - http://www.pall.com

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

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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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