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April 2000

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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 7 Apr 2000 07:19:04 -0400
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I would say the controlled environment is just that-- "controlled", to whatever specs YOU need or desire. CLeanrooms have specs for air changes, velocities, particles, viables, access, pressures and differentials, humidity, temperature, etc. etc. etc., specified by a number of regulatory bodies (most of which still aren't completely in-synch), and require constant monitoring of various parameters plus periodic certification of others. Some controlled environments could be as expensive or more so to maintain than some cleanrooms, depending on the level and types of controls.
M.Carroll
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------Original Message------
From: "Parker, MaryAnn" <[log in to unmask]>
To: [log in to unmask]
Sent: April 6, 2000 1:48:12 PM GMT
Subject: [PMFLIST] Cleanroom vs. Controlled Environment


Dear Members,

What makes a controlled enviroment a cleanroom?  I've always heard that
cleanrooms are more expensive to maintain and they require certification.
But, I can't find anything to support this.  What kind of certification is
required and why would it be more costly to maintain (other than paying for
someone to say it's a cleanroom)?  Any information would be appreciated.


MaryAnn Parker
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