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May 2006

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Subject:
From:
Mary Thomas <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 30 May 2006 17:56:14 +0000
Content-Type:
text/plain
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text/plain (209 lines)
Becky,

You are right. Our product is not  a pre-filled syringe and we do not supply 
syringes to the hospitals/pharmacies with our product. I agree that it is 
not in our cotrol and highly dependent on the clinic treatment of the 
syringe.

In the clinics on rare basis, due to some reasons the product has to sit in 
the syringe for 8-12 hours and we are asked to perform study to prove that 
there is no adverse effect on the sterility of the product after that perios 
of time.

Thanks.
Mary T




From: [log in to unmask]
Reply-To: The Pharmaceutical Microbiology Forum Email List              
<[log in to unmask]>
To: [log in to unmask]
Subject: Re: [PMFLIST] In-use syringe study
Date: Tue, 30 May 2006 09:59:57 -0500

If I understand correctly, your product is NOT a pre-filled syringe, is it?
Does that mean that the clinic will be filling the syringe?  Are you
providing the syringes with your product?

If the answers to my questions are Yes, Yes and No, I'm not sure how you can
prove this as it will be highly dependent on the clinic treatment of the
syringe (i.e., they will open it in a non-controlled environment and then
sanitize the stopper and then puncture the stopper), possibly the syringe
type (i.e., materials of construction, method of sterilization, packaging
and holding), etc.  A single organism permitted to enter the syringe or
container during the withdrawal would have lots of time to replicate during
the 12 hours if there are no inhibitory materials in your product.   Is
there a reason your clinics would want to prep syringes and then let them
sit out?

If the answer is that your product IS in a pre-filled syringe, then doesn't
your stability consider sterility at the beginning and end of shelf-life?

Becky

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]]On Behalf Of Mary Thomas
Sent: Tuesday, May 23, 2006 11:00 AM
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.

------------------
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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