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March 2020

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Subject:
From:
Bob Westney <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 20 Mar 2020 10:39:33 -0400
Content-Type:
text/plain
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Actually, I've learned that using the 99% cut-off value approach to
establish Action Levels can cause major headaches for very clean
facilities.  A couple of years ago I worked with a non-sterile facility
that was squeaky clean.  The resulting Action Levels were FAR below
compendial limits.  We decided to heed the guidance for Action Levels in
PDA TR 13: “Typically the Action levels will be driven by the regulatory or
industry guidelines. The Alert levels will be driven by historical analysis
of the environmental monitoring data.”

You can use the 95% cut-off value approach to establish Alert Levels.  Be
sure you have a streamlined investigation program for investigating Alert
Level excursions.  Do NOT bombard your Manufacturing and Engineering folks
with "hey, we got another Alert Level excursion!".  That turns into white
noise.  The red flag should only be raised if you (the microbiology expert)
find you an adverse trend (obviously it's always raised for Action Level
excursions).

Bob Westney
Director of Quality and Operations
Cryologics, Inc.
www.Cryologics.com

On Thu, Mar 19, 2020 at 9:34 PM Tony Cundell <[log in to unmask]> wrote:

> Use non-parametric 95% and 99% Confidence Limits
>
> On Thu, Mar 19, 2020 at 2:40 PM Abrar Ali <[log in to unmask]> wrote:
>
> > Dear Forum Members,
> >
> > Please suggest me how to establish statistical alert and action limit for
> > water system performance?
> > For the trend analysis I want to know how to establish the alert and
> > action limit when the results are alway less than 1 cfu/ml. Please
> suggest
> > what is the best way to
> > calculate it.
> >
> > Abrar Ali
> >
> >
> >
> >
> >
> >
> >
> >
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> > Steris - http://www.sterislifesciences.com/
> >
> > Charles River Laboratories - http://www.criver.com/
> >
> > Veltek Associates, Inc - http://www.sterile.com
> >
> > Microbiologics, Inc. - http://www.microbiologics.com
> >
> > BD Industrial Media - http://www.bd.com/ds/
> >
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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 is 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]
>
>
>
> Steris - http://www.sterislifesciences.com/
>
> Charles River Laboratories - http://www.criver.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> BD Industrial Media - http://www.bd.com/ds/
>
> 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 PMF or the sponsors of the
> list.
>

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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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Steris - http://www.sterislifesciences.com/

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

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

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

BD Industrial Media - http://www.bd.com/ds/

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 PMF or the sponsors of the list.

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