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February 2016

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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:
Sat, 20 Feb 2016 09:35:11 -0500
Content-Type:
text/plain
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text/plain (96 lines)
The Australian TGA has this stasis requirement. It is not found in the
harmonized sterility test as found in USP <71>.

My experience with the TGA when submitting an Penicillin derivative for
Australian approval they required a stasis test as part of the sterility
test method qualification. The penicillin was neutralized by the enzyme
penicillinase. We argued that the beta lactam ring would not magically be
re=assembled so the stasis test was unnecessary. My company was told
without running the stasis test the drug would not be approved.

On Fri, Feb 19, 2016 at 9:37 PM, Vinod Kumar <[log in to unmask]>
wrote:

> Hi,
>
> Can anyone suggest for requirement of Stasis test (to verify media
> fertility post sterility test) for products, Non-Antibiotics in nature and
> not having preservative contants.
>
> Vinod Jangied
> Mumbai,  INDIA
>
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
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.

Accuratus Lab Services http://www.accuratuslabs.com/

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

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

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

Biolog - http://www.biolog.com

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

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

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

Steris - http://www.sterislifesciences.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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