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May 2018

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Subject:
From:
Samir Shah <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 22 May 2018 09:16:54 -0400
Content-Type:
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I completely agree with Alan's view point. To add to the concept of risk
assessment- another valuable application of water activity test is to
support the stability of the products where performing challenge test is
not an option. You first show the microbial limits within specification and
support it by showing that the water activity during normal packaging and
shelf life is not increasing. Together it creates an excellent model to
support the microbial stability of products with water activity at or below
0.6.

*______________________________________________________________*
*Samir Shah Ph. D.*
*Global Microbiology, **Colgate-Palmolive Technology Center, NJ*
*Office 732.878.7772 / **VOIP 8-101-7772 / **Mobile 732.509.6666*



On Tue, May 22, 2018 at 3:36 AM, Alan Whipple <[log in to unmask]>
wrote:

> The water activity test should never be considered as an alternative to
> the microbial limit test. Water activity bears no relationship to
> microbial content! Low water activity only gives us assurance that
> microbial proliferation will not occur (it does not guarantee that microbes
> are not present).  Water activity is one of many factors that should be
> considered when justifying reduced testing of pharmaceutical products.
> Other key factors to consider include raw material quality, process risk
> and controls, and historical testing data. If a holistic review of all
> these factors shows that the product has a low risk of microbial
> contamination, then reduced testing can be justified.
>
> I personally see little value in routinely testing the water activity of a
> tablet or powder.  Such testing should only be applied to products where
> the water activity has a possibility of exceeding 0.6.  Why replace one
> redundant test with another?
>
>
> Alan Whipple
> Microbiology Director (AS&T)
> Consumer Healthcare
> Global Functions
>
>
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Jeanne Moldenhauer
> Sent: 21 May 2018 15:41
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Water Activity for Reduced Micro
>
> EXTERNAL
>
> I have several clients where we have implemented water activity in place
> of micro testing.  In all cases, we put it into the submission.  If there
> was a question from an auditor or investigator, we showed them it in the
> approved submission.  After that, there were no problems.
>
> Jeanne
>
> On Sun, May 20, 2018 at 11:03 AM Meredith, Sally <
> [log in to unmask]>
> wrote:
>
> > Dear PMF members
> >
> > Has anyone successfully justified reduced micro testing by
> > supplementing water activity instead of USP<61>/<62> using the
> > guidelines in USP<1112> Application of Water Activity Determination
> > for Nonsterile Pharmaceutical Products?
> >
> > How would auditors and regulators respond to this type of reduced
> testing?
> >
> > Thank you for your feedback!
> >
> > Sally Meredith
> > Scientist III, Quality Control
> > Pharma Services
> > Patheon, part of Thermo Fisher Scientific
> >
> >
> >
> >
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> Sartorius https://promotions.sartorius.com/real-heroes
>
> Steris - http://www.sterislifesciences.com/
>
> Avista Pharma Solutions  http://www.avistapharma.com
>
> MilliporeSigma  http://www.emdmillipore.com/
>
> Charles River Laboratories - http://www.criver.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Nelson Labs - http://www.nelsonlabs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Boston Analytical http://www.bostonanalytical.com/
>
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
>
> =================================
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> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> The Microbiology Network (http://microbiologynetwork.com) and supported by
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> Please take a second to visit our sponsors' web sites and say thank you
> for their support of this service.
> If your company would be interested in sponsoring this community, please
> contact [log in to unmask]
>
> Sartorius https://promotions.sartorius.com/real-heroes
>
> Steris - http://www.sterislifesciences.com/
>
> Avista Pharma Solutions  http://www.avistapharma.com
>
> MilliporeSigma  http://www.emdmillipore.com/
>
> Charles River Laboratories - http://www.criver.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Nelson Labs - http://www.nelsonlabs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Boston Analytical http://www.bostonanalytical.com/
>
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
>
> =================================
> 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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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
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.
If your company would be interested in sponsoring this community, please contact [log in to unmask]

Sartorius https://promotions.sartorius.com/real-heroes

Steris - http://www.sterislifesciences.com/

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


=================================
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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