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May 2001

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Subject:
From:
Dan Larrimore <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 10 May 2001 10:06:03 -0500
Content-Type:
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While we are on the subject of media fills, we have been informed by FDA
that "hand stoppering" of vials is no longer an industry practice.  By "hand
stoppering" I mean taking a sterilized stopper and aseptically placing it on
a vial with sterilized forceps.  This is not a frequent occurrence, as it
only happens when the stoppering mechanism misses a vial, and we perform
this during every media fill.  Do others in the parenteral industry perform
manual stoppering?  If so, have you received any feedback from FDA on this
practice?  Any insight on this matter would be appreciated. 

Dan Larrimore
QC Microbiology Supervisor
Cook                            
Cook Imaging
Cook Pharmaceutical Solutions




-----Original Message-----
From: Anthony Cundell [mailto:[log in to unmask]]
Sent: Wednesday, May 09, 2001 10:45 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Media Fill Practice


Jeff,

It makes no sense to incubate rejects that lack container-closure integrity
as they would not measuring the aseptic filling operation.

I believe the industry practice is to count and inspect the media fill and
classify the defects and enter all the filled units including cosmetic
defects into incubation.

An exemption would be filled units without container-closure integrity would
be recorded but not incubated.  

The level of defects in the media fill would be evaluated against the
product inspection reject levels to determine if it was typical.  With
non-routine intervenions the defect rates may be higher for media fills than
product. 

After incubation, all turbid vials after subculture should be examined for
container-closure integrity as part of investigation.  The sequence of the
vials filled should be maintained so the presence of a turbid vial may be
related to the level of activity in the filling area and if a non-routine
intervention occurred at that time.

Tony Cundell
Wyeth-Ayerst


>>> Jeff Werner <[log in to unmask]> 05/09 7:34 AM >>>
Members,

Recently, I have heard from several sources that the Agency has been
"asking" sterile drug manufacturers to incubate all media fill (process
simulation) units, even those units that did not pass a visual inspection
due to capping, crimping and other defects.  Do the members of this
discussion believe it is necessary to incubate obviously defective
containers, even grossly defective units, and units that would be removed
as part of the normal fill procedure?  Do you inspect units prior to
incubation?

If you incubate defective and rejected units, I assume you incubate all
units, segregating those that would fail a visual inspection?  Do you use
the units that failed the visual inspection in your assessment of the
adequacy of the line to fill sterile product (i.e. count any positives
found against your media fill acceptance criteria) or is this information
kept to better understand your process and show the need for robust
inspection methods?

Please comment as to your opinion and the Agency's rationale for this new
"request".  Thanks in advance.

[log in to unmask], V-P PMF


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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.



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