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May 2006

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Subject:
From:
Daniel Prince <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 15 May 2006 14:20:22 -0400
Content-Type:
text/plain
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We modify ASTM F1608 to test 10 vials and two controls. We use B. dimunita.
The sterile vials, if integrity, will prevent the ingress of the organism
whilst the partially closed controls will not.

Sincerely,
Daniel L. Prince, Ph.D.
President
Gibraltar Laboratories, Inc.
122 Fairfield Road
Fairfield, NJ 07004
973-227-6882 ext. 519
973-227 0812 FAX
www.gibraltarlabsinc.com



 

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Stephanie Thomas
Sent: Friday, May 12, 2006 12:57 PM
To: [log in to unmask]
Subject: [PMFLIST] Microbial ingress for container closure integrity test

Where can I find a method to perform microbial ingress test on media filled
vials. How many vials do we use? We filled approximately 300 vials with TSB
just for the CCIT test. Before submitting for the tests I incubated the
vials at 20 to 25 deg for 7 days followed by 30 to 35 for an additional 7
days. This is to make sure that my vials are indeed sterile before I submit
them for microbial ingress test. What is the organism used? Is it P.
diminuta or E.coli? And how many vials do I use?
  Thank you all for your input.

		
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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

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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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

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