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November 2019

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Subject:
From:
Dale Kelley <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 22 Nov 2019 16:10:37 +0000
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Reuven,

It depends primarily on contamination risk. For example, if your Class C room contains Class A LAFs that are used for aseptic compounding then the workers should be wearing masks. If the activities in your Class C room do not impact any aseptic processes and you have appropriate personnel and materials movement controls in place, you could justify not wearing masks.
Hope this helps,

Dale Kelley
Director
Protocol Link, Inc.
175 E. Hawthorn Parkway, Suite 210
Vernon Hills, IL 60061 USA
office +1-847-549-0390
www.protocollink.com





-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Reuven Baum
Sent: Friday, November 22, 2019 5:48 AM
To: [log in to unmask]
Subject: [PMFLIST] nuclear pharmacy

A nuclear pharmacy preparation room classified as  Class C, do the workers need face masks  all the time they are in the room or only when performing specific aseptic  tasks ?
  I have trouble understanding the guides especially USP chapter 797 and the Emea Annex 1. Annex 1 suggests that in Class C a face mask is not needed.
USP 797 is unclear to me in its recommendations on face masks.


Thanks for any help.
Reuven
Yavne
QC microbiology

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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]



Science Advisory Board https://www.scienceboard.net/

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/

Boston Analytical http://www.bostonanalytical.com/

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

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