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May 2006

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Subject:
From:
"Hewitt, Jackie" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 16 May 2006 08:51:13 -0400
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text/plain
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Stephanie,

I did see an official method some years ago but I have not been able to find the
reference. However, here is our procedure:
7 sets  of 4 vials per capper head per test plus 14 vials for GPQs and 4 for +/-
controls : initial, 1, 2, 3, 4, 5 years tests plus one extra set in case repeats
are needed (for us this is 478 total). We normally schedule this around our
media fills and use the vials after 14 days incubation. We have made up  vials
in the lab, but capping really needs to be on the production capper as hand
capping in the lab is not equivalent. They are autoclaved to represent worst
case on closure. Organisms: B. subtilis and B. diminuta, grown together in a
stockpot. Count the concentration after 2-3 days. 
(+) controls inoculated with 10-100 CFU of stockpot culture. (+) and (-)
controls not processed but incubated with test.
Test vials are dunked into stockpot and the pot refrigerated for 2 hrs, then
incubated at 30-35C for 2 hrs. This cycle is repeated, with counts on stockpot
after each stage. After 2nd incubation, the vials are removed and shaken for 2
minutes. They are incubated for 7 days at 30-35C, inspected for growth, then
incubated at 20-25C for 7 days and inspected. Storage is in a stability chamber.

Hope this helps.

Jackie Hewitt
Microbiology Manager
Luitpold Pharmaceuticals
Tel.  (631) 924-4000 x 321
FAX (631)205-2075
E-mail  [log in to unmask]


-----Original Message-----
From: Stephanie Thomas [mailto:[log in to unmask]] 
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 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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