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December 2015

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 1 Dec 2015 16:58:31 -0500
Content-Type:
text/plain
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Sylvain,

From USP <71> Table 2 you can determine the minimum quality of product to
be used for each media which for fills less than 1 mL is the entire
contents of the container for each media.

From Table 3 for batch sizes greater than 500 you use 2% of the lot or 20
containers, whichever is lees.

As your lot size is greater than 500 container you would use the entire
contents of 20 container per media.

QED

Tony



On Tue, Dec 1, 2015 at 11:05 AM, Sylvain Rousseau <[log in to unmask]>
wrote:

> Dear PMF members
>
> With colleagues we are struggling how to interpret the Chapter <71< from
> USP
>
> Let consider the following examples if a filled batch is made of 10 000
> vials, each vials are filled at 0.7 mL.
>
> How many vials are required to perform the sterility test according to USP
> <71> and do we need to pass half the content on each medium (TSB, FTM) ?
>
> In order words do we need to use 40 vials;  The whole content of 20 of
> those vials will be used with TSB and another set of 20 vials and the whole
> content will be used with FTM
>
> Or
>
> Can we used half of the content of 40 vials on TSB and the other half on
> FTM ?
>
>
> Thank you for your help
>
> Sylvain
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors 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.

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

Accugen Laboratories - http://accugenlabs.com

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

Analytical Research Labs - http://arlok.com/

Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

American Type Culture Collection - http://www.atcc.org

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

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

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Nelson Labs - http://www.nelsonlabs.com

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



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