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February 2020

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Subject:
From:
Jovan Rankov <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 7 Feb 2020 07:17:23 +0000
Content-Type:
text/plain
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Dear Kerri,

In my company we are doing continuous monitoring in grade A and grade B area surrounding the filling line. So all samples in the aseptic filling room are continuously exposed for passive air sampling during set-up and filling.

Jovan





-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Kerri Orszula
Sent: Thursday, February 6, 2020 3:29 PM
To: [log in to unmask]
Subject: [PMFLIST] FW: Annex 1- Gr B cont viable monitoring

I didn't see this one post so I am resending. Thank you!

From: Kerri Orszula
Sent: Wednesday, January 15, 2020 12:02 PM
To: [log in to unmask]
Subject: Annex 1- Gr B cont viable monitoring

Dear Forum,
      The Annex 1 draft has verbiage indicating continuous viable monitoring should be performed in Grade A and B for the full duration of critical processing. This seems to suggest that Grade B should be continuously monitored for viables.

How is this being interpreted? Is this something you will be implementing or will you be writing a risk assessment to justify why continuous viable monitoring in Grade B is not needed?

Thank you,
Kerri

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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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