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May 2001

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Subject:
From:
Michael C Carroll <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 10 May 2001 13:51:13 EDT
Content-Type:
text/plain
Parts/Attachments:
text/plain (161 lines)
That's what one would call a VERY "high-risk" practice, for an aseptic
operation-- first off, the failure to stopper might have produced more
turbulence at the vial opening, and it DID produce a much
longer-than-normal exposure time for the open, filled vial; plus there's
the additional manipulation in the sterile field; then there's SEATING
the manually-placed stopper (unless done automatically at a later stage).
I don't think even a media simulation would justify that, even with a
very high-value product. I've been flat-out told by investigators that
unstoppered filled units were rejects, period. Anyone else??
M.Carroll
([log in to unmask])

On Thu, 10 May 2001 10:06:03 -0500 Dan Larrimore
<[log in to unmask]> writes:
> 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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