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May 2006


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Stephanie Thomas <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Wed, 24 May 2006 16:05:44 -0700
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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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