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May 2018

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Subject:
From:
Alan Whipple <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 22 May 2018 07:36:29 +0000
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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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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
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/


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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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