PMFLIST Archives

May 2006

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
"Wong, Jeffrey" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 25 May 2006 15:48:16 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (135 lines)
Stephanie,
	As per Annex 1 the "at rest" or static values must be met in the
unmanned state after operations in the area have ceased and following a 15 -
20 minute "clean up" time.  We use Met-One particle counters and set the
unit for a 15 minute delay and leave the room.  We have not had any problems
with the static monitoring thus far.  Hope this helps.

Jeff

-----Original Message-----
From: Stephanie Thomas [mailto:[log in to unmask]] 
Sent: Wednesday, May 24, 2006 7:06 PM
To: [log in to unmask]
Subject: [PMFLIST] 5.0 micron particle

Under EU requirements,  Grade B (class 10,000) in static condition should
not have more than one 5.0 micron particle. We find this hard to meet.  My
analyst measures particles using climet and steps out of the room while the
device runs so that she gets a true static value.  Two readings of 1 cubic
ft per min are taken and averaged. At times we get an average of 0.5
particles of 5.0 micron. Since our SOP had been revised to reflect EU
requirements, every time we get one particle it exceeds the action level.
Too many investigation reports are generated.
  Those who work in a sterile manufacturing facility, how do you handle such
situations?
  Thank you all for your wonderful support.

		
---------------------------------
Yahoo! Messenger with Voice. PC-to-Phone calls for ridiculously low rates.

------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

ATS Laboratories - http://www.ats-labs.com

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

Millipore - http://www.millipore.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Raven Biological Labs - http://www.ravenlabs.com

Veltek Associates, Inc - http://www.sterile.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.





EMAIL DISCLAIMER 

Please Note: The information contained in this message may be  privileged and 
confidential, protected from disclosure, and/or intended only for the use of
the individual or entity named above. If the reader of this message is not
the intended recipient, or an employee or agent responsible for delivering
this message to the intended recipient, you are hereby notified that any
disclosure, distribution, copying or other dissemination of this
communication is strictly prohibited. If you received this communication in
error, please immediately reply to the sender, delete the message and 
destroy all copies of it.

Thank You

------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

ATS Laboratories - http://www.ats-labs.com

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

Millipore - http://www.millipore.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Raven Biological Labs - http://www.ravenlabs.com

Veltek Associates, Inc - http://www.sterile.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.

ATOM RSS1 RSS2