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December 2002

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Mon, 9 Dec 2002 10:01:38 +0200
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Frank

Whilst I see your point, the guidelines you give are not exactly written as
such in the EP with this type of product in mind.

Yes, one can apply them to a lab suspended sample, but then if it does not
comply, can we definitely say that the guidelines used are correct? Are
they not too strict? These are what we could call in-house limits, right?

I think I would still like to see what Roger and Tony would say about it
from a USP point of view!

But thanks that was great insight!

Fausto



                    Frank
                    vanderzanden         To:     [log in to unmask]
                    <zanden.d.v.f@       cc:
                    EMCM.COM>            Subject:     Re: [PMFLIST] Question regarding PET
                    Sent by: The          test
                    Pharmaceutical
                    Microbiology
                    Mail List
                    <PMFLIST@MICRO
                    BIOL.ORG>


                    06/12/2002
                    16:36
                    Please respond
                    to The
                    Pharmaceutical
                    Microbiology
                    Mail List






[i] The antimicrobial activity of the preparation in its final container is
investigated over the period of validity to ensure that such activity has
not been impaired by storage. Such investigations may be carried out on
samples removed from the final container immediately prior to testing.
During development of a pharmaceutical preparation, it shall be
demonstrated that the antimicrobial activity of the preparation as such or,
if necessary, with the addition of a suitable preservative or preservatives
provides adequate protection from adverse effects that may arise from
microbial contamination or proliferation during storage and use of the
preparation.
The efficacy of the antimicrobial activity may be demonstrated by the test
described below. The test is not intended to be used for routine control
purposes. [/i]

The text above is from the PhEur (5.1.3). The last alinea is important for
you. It says that the described method may demonstrate the efficacy. Why
botter to take other timepoints of sampling. Let's say 24 hour, 2 days and
seven days. The spec's good be like a 3 log reduction for bacteria after 2
days and no increase after 7 days!
I think this would be sufficient to comply with the test (in fact you have
worst case situation, as you use more strict specification for your
product).

Best regards,

Frank van der Zanden
Bactimm BV - the Netherlands


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