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Subject:
From:
JUAN JOSE VERAMENDI ORTIZ <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 21 Jul 2020 22:25:15 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (160 lines)
A large number of products can be resistant to neutralization, one of many
cases may be anti-inflammatory, antipyretic, and analgesic activity, these
products in formulation enhance preservatives, making neutralization and
recovery more difficult, one tip is that you should  study the formula of
your product and on the basis that it make decisions

El mar., 21 de julio de 2020 10:40 a. m., Donald English <
[log in to unmask]> escribió:

> 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)
> >
> > www.advancedlabsinc.com
> >
> > *If you liked our service, please tell a friend.  If you didn’t, please
> > tell us!*
> >
> > ISO/IEC 17025:2017 Accredited  |   UT Lab FDA Registration #
> 14353128308  |
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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
> >
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> The PMFList is supported by our sponsors as a service to the scientific
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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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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/


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