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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 24 Jun 2020 11:15:36 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (107 lines)
Dear Ulku,

I think that you are confusing equipment cleaning and equipment
sanitization.

For equipment cleaning, most people will set either a Total Organic Carbon
(TOC) or Conductivity limit for a deionized water rinse in which they are
measuring the presence of product residues and cleaners on an equipment
surface after completion of the cleaning process before equipment
sanitization is conducted.

For equipment sanitization, most people will set a limit based upon the
microbial test specifications for a finished product.  Unlike air sampling
and water sampling of a purified water system, I have not seen people set
alert and action limits for the numerical levels of microorganisms that may
be present on an equipment surface after equipment sanitization.  If you
are going to set alert and action limits for equipment surfaces after
sanitization, you need to base it on data collected.

However, I do question the purpose for setting alert and action limits
after an equipment surface has been sanitized. Instead of setting alert
and action levels, most people will validate their cleaning and
sanitization procedures for manufacturing equipment. I can see performing
periodic monitoring of equipment surfaces to ensure that there is no drift
in how cleaning and sanitization procedures are performed after validation
of the cleaning and sanitization procedures for equipment.

Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932




On Wed, Jun 24, 2020 at 8:29 AM Mirza Oz, Ulku <[log in to unmask]>
wrote:

> Dear all,
>
> Could you please tell me your approach regarding setting alert/action
> limits for microbiological evaluation of cleaning validation studies?
>
> Do you use same limits for sampling “before cleaning” and sampling “after
> cleaning”?
>
> Thanks in advance,
> BR
>
> Ulku
>
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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.
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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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/


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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 PMF or the sponsors of the list.

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