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June 2020

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Subject:
From:
DAANE Lori <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 19 Jun 2020 11:58:44 +0000
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Hello Yavne,
I think you're looking for USP <823> Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses.  Section 8 provides information on controls and acceptance criteria for finished products.  It also references USP <71> as another sterility method that can be used.

Best,
Lori Daane

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Reuven Baum
Sent: Thursday, June 18, 2020 3:10 PM
To: [log in to unmask]
Subject: [PMFLIST] rapid sterility

External Email

I remember reading a justification for sample size for sterility tests for small batch sizes for example in radiopharmaceuticals. It contained a calculation of what percent  to use from the batch.
I think it was in the USP.
Can anyone help me find it?

Reuven
QC
Yavne

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Veltek Associates, Inc - https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterile.com%2F&amp;data=01%7C01%7Clori.daane%40biomerieux.com%7C7ef9b4ebb56b4755ec0708d81421e27e%7Caec0543acc734fa49e2acf52adf9b788%7C1&amp;sdata=NaZW8yCdSdRAx8nww3AtWiLK12pzIxmrxSVNp2OBFU0%3D&amp;reserved=0

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

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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

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

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.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 PMF or the sponsors of the list.

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