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December 2015

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Subject:
From:
"Anderson, George O" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 2 Dec 2015 17:07:13 +0000
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Late with my comments, but this is what I would do.  If it's not an antibiotic: 40 units are required in total using 20 units per sterility test and the entire 0.7 mL.  The entire contents (0.7 mL) of 20 units per each broth growth media (TSB and FTM).  If you use a USP <71> required membrane filtration device you could also do one test initially and then cut the membrane in half and deposit 1/2 in each bottle of growth media (TSB and FTM).

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Tony Cundell
Sent: Tuesday, December 01, 2015 2:49 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] How to understand USP <71>

This recommendation appears to contradict the USP <71> requirement that the entire contents of a vial less than 1 mL be used for each media.

On Tue, Dec 1, 2015 at 4:40 PM, Liliana Dogaru <[log in to unmask]>
wrote:

> The way we implemented this requirement is each vial is split between
> the
> 2 canisters.  Since the fill size is less than 1mL - 1mL fill size
> would give you the minimum of 10mL per membrane - you need indeed 40 vials.
> However, as I stated before, splitting each of the 40 vials onto 2
> membranes is the better way to go.
>
> Hope it helps,
> Liliana
>
> Liliana Dogaru
> QC Sr. Manager
> Sterility and Microbiology Support
> (MicroID/Method Validation)
>
> "Great Minds Like a Think" - The Economist
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Sylvain Rousseau
> Sent: Tuesday, December 01, 2015 8:05 AM
> To: [log in to unmask]
> Subject: [PMFLIST] How to understand USP <71>
>
> 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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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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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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