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May 2001

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Subject:
From:
Ward Nelson <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 11 May 2001 10:52:31 -0700
Content-Type:
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Our practice of manual stoppering is consistent with yours.  Although it is a
somewhat infrequent occurrence we include it as a routine intervention in every
media fill.  We have also qualified the operation with smoke studies. The FDA
and other authorities have not taken issue with it.

Ward Nelson
Genentech, Inc.

Dan Larrimore wrote:

> 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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