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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:
Mon, 20 Jul 2020 23:31:30 -0400
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Dear Kristin,

I have a question on your post. Did you failed neutralization against all of the 5 challenge test organisms?  If the product had failed against all 5 challenge test organisms for the AET, the product may be hostile to contaminating organisms and challenge testing might not be required.  See ISO 29621 for the factors that makes a formulation unsusceptible or hostile to microbial contamination. 

If one organism has failed neutralization, I would recommend that challenge testing still be conducted with the organism to show that it is not possible for it to survive or proliferate in the formulation.   An example of a product that has neutralization issues is Zinc pyrithione antidandruff product formulations in which it is very difficult to recover Candida albicans for an AET.  It is not surprising because dandruff is caused by a yeast and Zinc pyrithione is active against the yeast (Malassezia)) that causes the condition.

Don

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

Sent from my iPhone

> On Jul 20, 2020, at 3:37 PM, Kristen Peters <[log in to unmask]> wrote:
> 
> 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)
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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/


=================================
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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