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May 2006

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Subject:
From:
Scott Sutton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 3 May 2006 07:22:40 -0400
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Beth,

Part of the problem here is a semantic one.  The Sterility Test (USP <71>)
is intended to be a referee test - one performed on a product about which
you know nothing.  In this situation, the B/F test is performed once on each
of the organisms to demonstrate method suitability.  This is not how most of
us use the test, however.

If you wish to demonstrate method suitability for a product you will be
testing repeatedly, it is probably a good idea (note I did not say
requirement) to show some level of reproducibility.  This is commonly done
by testing at least three batches.  

Why three?  I don't know - although I have heard it said that once is an
occurrence, twice a coincidence and three times is statistics.  I don't
think there is a good reason other than three times is an accepted
convention.

If you have demonstrated method suitability for your test on at least three
separate batches you probably do not need to repeat it unless you change
something (manufacturing raw material supplier, process, location,
media/reagent supplier, etc).  

However, you should be aware that the PIC/S (Pharmaceutical Inspection
Convention and Pharmaceutical Inspection Co-operation Scheme - collaboration
of international regulators - see
http://www.picscheme.org/indexnoflash.php?p=members) guidance on Sterility
Tests states that "it is good laboratory practice to re-validate under the
current experimental conditions every 12 months." (Section 11.6.2.4,
document citation below)  Why?  I have no idea, except perhaps as an aid to
employ our excess labor resources.  I have not seen too many labs (none that
come to mind) fritter away resources performing annual revalidations of
unchanged products - but that is only my experience and perspective.

This has been a long answer, sorry about that.  

Short answer is: do it three times to validate ongoing product testing, once
for a one-off test.  Bear in mind that some Canadian/Euro/Australian/etc
regulators might be looking for annual revalidations.

Scott

Note: 
PIC/S Guidance Doc Page:  http://www.picscheme.org/BAK/pubs/pubs.htm
PIC/S Sterility Test Guidance:
http://www.picscheme.org/BAK/docs/pdf/PI%20012-2%20Recommendation%20on%20Ste
rility%20Testing.pdf  (may need to cut and paste entire URL into browser
window)

======= 
Scott Sutton, PhD
Pharma Consultant, Microbiology
Vectech Pharmaceutical Consultants, Inc
+1 585-594-8273 
This Message is privileged, confidential and protected by law from
disclosure. If you received this message in error, then forward it to
[log in to unmask] and delete it from your system.
 

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Derenne, Elizabeth M.
Sent: Monday, May 01, 2006 11:34 AM
To: [log in to unmask]
Subject: [PMFLIST] test validations

Forum,

 

Is it required to perform Bacteriostasis and Fungistasis testing ONE
time on a product or THREE times?  I was under the impression it was
three times, per USP chapter 1227, however I have noticed several
contract research orgs websites that state this test only needs to be
done once.  Which is correct?

 

 

Beth Derenne

 


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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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