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March 2020

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Subject:
From:
Juan Ortega <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 11 Mar 2020 19:01:45 +0000
Content-Type:
multipart/related
Parts/Attachments:
text/plain (3416 bytes) , image001.png (14 kB)
Hello,

Since the example is given in Spanish, I am responding in Spanish. Here is my opinion:

  1.  Si el limite maximo de aceptacion es 10 UFC/g.  Lo maximo acceptable son 20 UFC/g.



Similarmente para los otros dos ejemplos siguientes.



No recomendaria este criterio, porque permite aceptar un material 2x el limite de aceptacion.



Thank you,

[cid:image001.png@01D5F7AD.9896A4F0]



Juan R. Ortega, MPM

Microbiology Supervisor – Validations

Business Unit Operations – North America

Pharmaceutical and Device Division



Fresenius Kabi USA, LLC

2020 Ruby Street

Melrose Park, IL

Office: +1.708.450.7508

www.fresenius-kabi.com/us



-----Original Message-----
From: EXTERN The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Sent: Wednesday, March 11, 2020 10:34 AM
To: [log in to unmask]
Subject: [PMFLIST] <1111> USPc



Good afternoon







I request please confirm us the validity of the interpretacion mentioned in chapter <1111> about microbiological specification:











Thank you, I hope for your answer





Helga Rivas



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------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and 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 - http://www.criver.com/

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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

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