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December 2003

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Subject:
From:
"Prinzi, Sam" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 9 Dec 2003 12:12:22 -0500
Content-Type:
text/plain
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text/plain (67 lines)
It depends on the duration or the outage.
If its to long then a cleaning would be done and then the monitoring as
follows:
        If the HEPA's are down from more than 1 hour then it's a complete
monitoring - Contact, Viable particles and Non-viable particles.


We have had many inspections and the FDA has not questioned this procedure.

Sam Prinzi
Genzyme Biosurgery
QC Unit Manager of Microbiology
Office (617) 761-8722
Fax (617) 252-9909


-----Original Message-----
From: Wireko Manu-Tawiah [mailto:[log in to unmask]]
Sent: Tuesday, December 09, 2003 8:44 AM
To: [log in to unmask]
Subject: [PMFLIST] CLEAN ROOM AREAS PROCEDURES AFTER POWER FAILURE


I would like to know what procedure others follow for their clean room areas
after a power failure.

Wireko Manu-Tawiah, Ph.D.
Wyeth Pharmaceuticals,
Tel:845-602-2349
[log in to unmask]

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