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February 2016

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sun, 28 Feb 2016 17:32:52 -0500
Content-Type:
text/plain
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Uday,

Your monitoring program should reflect the reliability of your incoming
water supply. Companies I worked for tested incoming water monthly or
quarterly and received routine test reports from the water authority.

Based on US EPA regulations, the 500 cfu/mL is a target not a specification
and the coliform regulation are based on the number of people served by the
water supplier and is expressed in a frequency of isolation of fecal
coliforms, i.e. E. coli. The water authorities adjust the chlorination and
issue boil notices when E. coli is found.

Tony

On Wed, Feb 24, 2016 at 9:18 PM, Uday Bhatambarekar <[log in to unmask]>
wrote:

> I would like to know what the general consensus is on identifyiing ithe
> isolates from feed water. Our specification calls for only absence of
> coliforms. Our internal SOP has an action limit of 500 cfu/ml and an
> alert limit of 200 cfu/ml.  We do identification
> quarterly.  I want to drop the identfication completely from this drop.
> We do test other drops such as after carbon filter, water softener,
> after RO membrane unit,  after 0.2 micron filter and use points.
> Identification on use points are done as isolated.  On process points we
> were doing monthly but we want to cut it down to only when it exceeds
> alert limit. I do not see any value in identifying colonies from the
> feed. We have only non sterile solid oral dosage forms.
>
> Uday Bhatambarekar
>
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
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.

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/

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

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

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

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