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July 2020

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Subject:
From:
"Dr. Michael J. Miller" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 20 Jul 2020 16:03:36 -0400
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That depends. You can use neutralizers in a membrane rinse fluid and in the final medium. You can also dilute the preparation under test as long as the dilution is not too high that you cannot make a determination if the required log reductions are achieve that the relevant time points. IN fact, USP 51 states if you need to make significant dikutions you may have to inoculate with a log higher concentation of challenge organisms.

 

Or, you can do a combination of dilution and neutralizers. 

 

The expectation is that you employ all of these strategies. 

 

Michael

 

Michael J. Miller, Ph.D.

President
Microbiology Consultants, LLC
19009 St. Laurent Drive, Lutz, FL 33558
phone: 727-437-2743 (RAPID-RAPID)
email: [log in to unmask] 
web: http://microbiologyconsultants.com
linkedIn: http://www.linkedin.com/in/drmichaelmiller

http://rapidmicromethods.com – advancing the science and implementation of rapid microbiological methods.

 

 

 

From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Kristen Peters <[log in to unmask]>
Reply-To: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date: Monday, July 20, 2020 at 3:38 PM
To: <[log in to unmask]>
Subject: [PMFLIST] Failed Neutralization in Suitability Testing

 

All - does anyone know what the USP recommends if the suitability test

fails using neutralizing agents? What is the next step, can we proceed with

the PET/AET on the product?

 

Kristen Peters

General Manager

Advanced Laboratories, Inc. North Carolina

919-989-7793 <(919)%20989-7793> (NC Lab, FDA Reg #10560615298)

919-989-9226 <(919)%20989-9226>(Fax)

 

www.advancedlabsinc.com

 

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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.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



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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