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February 2016

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Subject:
From:
Matthew Moreno <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 3 Feb 2016 19:21:57 +0000
Content-Type:
text/plain
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Hi,

You would just perform the Bacteriostasis and Fungistasis Test in USP <71> if concerned.

The USP <71> Sterility Test contains two qualifying assays which must be performed prior to sterility testing. They
are the "Suitability Test" (Growth Promotion Test) and the "Validation Test" (Bacteriostasis and Fungistasis Test).

The Validation Test is used to determine if the test sample will inhibit the growth of microorganisms in the test
media. Stasis, in terms of microbiology, is defined as the inability of a microorganism to grow and proliferate in
microbiological media. Media that is bacteriostatic does not necessarily kill bacteria; it simply may retard bacterial
growth and proliferation. The Validation Test must be performed on each product prior and/or during
sterility testing. This test determines if the media volumes are valid for the particular product. Some medical
products contain bacteriostatic and fungistatic compounds that may require special procedures and special
media for testing. This test is similar to the Suitability Test described above, however, the product sample is
placed in the media along with the microorganisms. Microbial growth in the presence of the test samples is
compared to controls without test samples. If microbial growth is present in the sample and control containers,
then the test is valid. The next step is to proceed to actual sterility testing. Suitability, validation, and sterility
tests can be performed simultaneously.
Matt

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Hoegh, Ellen Alexandra (GE Healthcare)
Sent: Wednesday, February 03, 2016 7:37 AM
To: [log in to unmask]
Subject: [PMFLIST] Sterility test kit from Merck Millipore

Hi

I assume that several of you uses the sterility test kits from Merck Millipore and have received the change notification from them in February 2015 and an update in December 2015: 
http://image.exct.net/lib/fe5a157072630d7c7c17/m/1/Steritest+Tubing+Follow-Up_Final+Notification_29Dec15.pdf

 It is regarding a change of a softener that is used in the PVC tubing in some of their sterility test kits. Merck Millipore have performed several studies showing that this change will not affect the use of the sterility test kit, but they have of course not performed any test with specific products. 

What assessments have you performed for this change notification and what has been in focus? 
Is it a possibility that your own products can extracted out extractables or leachables from the tubing that have influence on the growth of test organisms?

Have any labs performed any re-validation / verifications of the sterility test due to possible impact of own products on the new tubing? 

Thanks and regards
Ellen 


Ellen A. H√łegh
Microbiological Development

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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/

Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

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

Accugen Laboratories - http://accugenlabs.com

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

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

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Steris - http://www.sterislifesciences.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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