Dear Stephanie,
try to read the New GMP Annex 1: Proposals for amendment...
I've found it very interesting and it has given me a good point of view.
(the link to download it is
http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/11_05/Annex%201%20amended%2009-2005.pdf
)
Let me know if it helps you.
Best Regards
Alessandro


Dr Alessandro Ciacco
[log in to unmask]
www.moltenifarma.it
L. Molteni & C. dei F.lli Alitti S.p.A.
Quality Assurance Coordinator
S.S. 67 LocalitÓ Granatieri 50018 Scandicci (Fi) Italy
Tel. +39/55/7361269
Fax + 39/55/7361235


                                                                                                                           
                    Stephanie Thomas                                                                                       
                    <stephanie_thomas900@   Per:    [log in to unmask]                                            
                    YAHOO.COM>              Cc:                                                                            
                                            Bcc:                                                                           
                    25/05/2006 01.05                                                                                       
                    Per favore,                  Oggetto:     [PMFLIST] 5.0 micron particle                                
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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.


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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

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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.