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.