PMFLIST Archives

July 2020

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
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 14:21:39 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (110 lines)
Cap 51 is very specific in the methods to be used as well as increasing the
chances of success. I also recommend reading the additional supplement of
Cap 51 if you need it, I can send it by inbox, additionally the method you
use to neutralize will be the daily analysis  so the final method.

El mar., 21 de julio de 2020 4:40 a. m., JUAN JOSE VERAMENDI ORTIZ <
[log in to unmask]> escribió:

> 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
>>
>> *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
>> |
>> NC Lab FDA Registration # 10560615298
>>
>> CONFIDENTIALITY NOTICE
>>
>> The information contained in this e-mail correspondence is intended solely
>> for the use of the individual or entity to which it is addressed, and may
>> contain information that is PRIVILEGED and CONFIDENTIAL. If you are not
>> the
>> intended recipient, you are hereby notified that any disclosure,
>> duplication, distribution or the taking of any action in reliance upon
>> this
>> correspondence is strictly prohibited. If you received this correspondence
>> in error, please notify the sender by phone, fax, or e-mail and destroy
>> any
>> and all copies of the correspondence. Thank you.
>>
>> ------------------
>> 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/
>>
>>
>> =================================
>> 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.
>>
>

------------------
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/


=================================
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.

ATOM RSS1 RSS2