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May 2006

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Subject:
From:
"Khandelwal, Nand" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 24 May 2006 21:03:52 +0530
Content-Type:
text/plain
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text/plain (134 lines)
Mary:

You can fill the syringe with TSA Medium and expose the same for 12
hours as you do with your product, incubate the same for 14 days at
20-25 ( 7days) followed by 30-35 ( 7 days) and check for the sterility. 

However, you have to check other variable factors such as microbial
evaluation of the environment before performing this study.

N.K. Khandelwal, Ph.D 

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Mary Thomas
Sent: Tuesday, May 23, 2006 8:30 PM
To: [log in to unmask]
Subject: [PMFLIST] In-use syringe study

Dear Forum,

We are planning to perform "In-use Syringe Study" for our product. Our 
product is an injectible  and we want to show that our product remains 
sterile if sitting in the syringe for 10-12 hours in the clinic. We do
not 
have any preservative in our product.

Now there are different options/opinions to perform this study are
ongoing. 
One suggestion is to fill the product in the syringe and leave it for 12

hours and perform sterility test to prove that product remains sterile
after 
12 hours.

Another suggestion is to incubate the product in the syringe with USP
<51> 
specified and counting the inoculums after leaving it for 12 hours .

I know that companies perform studies for pre-filled syringes and
assuming 
they may have preservative added in it. I would like to know the
approach if 
the study is performed for pre-filled syringe without preservative.

Any information /reference will be appreciated.
Thanks in advance.
Mary T

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------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

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

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

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

Millipore - http://www.millipore.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Raven Biological Labs - http://www.ravenlabs.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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