PMFLIST Archives

December 2015

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Sylvain Rousseau <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 1 Dec 2015 16:05:27 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (70 lines)
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
________________________________

Ce courriel et toute pi?ce jointe y ?tant attach?e peut contenir de l'information concernant Medicago Inc. qui est privil?gi?e, confidentielle ou prot?g?e contre la divulgation. L'envoi de ce courriel est destin? exclusivement au(x) destinataire(s) mentionn?(s) et ne constitue pas une renonciation ? un droit de quelque nature que ce soit. Toute utilisation, transmission ou copie non autoris?e de ce courriel est interdite. Si vous avez re?u ce courriel par erreur, veuillez imm?diatement en aviser l'exp?diteur de Medicago Inc. et d?truire toute copie en votre possession. L'exp?diteur et Medicago Inc. ne sont pas responsables des dommages ou responsabilit?s caus?s directement ou indirectement par la r?ception de ce courriel.



This email transmission and any accompanying attachments may contain Medicago Inc. privileged or confidential information, or information protected from disclosure. This email is intended only for the use of the recipient and does not waive any potential right. Any dissemination, distribution, copying or use in reliance on the contents of this email by anyone other than the intended recipient is strictly prohibited. If you have received this email in error please immediately delete it and notify sender at the above Medicago Inc. email address. Sender and Medicago Inc. accept no liability for any damage caused directly or indirectly by receipt of this email.



------------------
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/



=================================
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.

ATOM RSS1 RSS2