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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 04:40:34 -0500
Content-Type:
text/plain
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text/plain (96 lines)
Chapters 51/61 and 62 of the USP specify 3 methods, these methods can be
combined in order to obtain the neutralization, if in the end nothing works
you can evaluate and apply the resolution of these chapters in which you
can specify that the product is little  or impossible to become
contaminated.  but you should try to exhaust the possible neutralizations...



El lun., 20 de julio de 2020 2:39 p. m., Kristen Peters <
[log in to unmask]> escribió:

> 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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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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