The latest proposed amendment to the EU GMPs has a footnote which
effectively allows a count of 20 particles at 5.0 microns. At the same time
the document indicates that it is being brought into line with ISO 14644
part 1 - although the equivalent limit there is given as 29. In addition,
the draft has been amended to read '5.0' instead of '5' - an implied
increase in precision that may well not be justified.
A number of comments have been submitted on these and other issues concerned
with the proposed revisions to Annex 1. It will be interesting to see
whether any of those comments will be taken into account when the ad hoc
Inspectors Group finalise the amendments. I do not think that we can hold
out much hope for this based on experience with the last two changes to the
guidelines - the first of which was imposed with no consultation, while the
second was consulted on but none of the comments appeared to have been
----- Original Message -----
From: "Stephanie Thomas" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Thursday, May 25, 2006 12:05 AM
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.
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