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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:
Wed, 9 May 2001 08:06:13 EDT
Content-Type:
text/plain
Parts/Attachments:
text/plain (70 lines)
If a visual inspection and culling of obvious defective units is part of
the normal fill process, which it invariably is, this process is done for
media fills, and defectives are culled and rejected without incubation,
just as defective product units would be removed and not sold. To
incubate obviously defective items which would normally be removed and
rejected in the normal process, is absurd.
M.Carroll ([log in to unmask])

On Wed, 9 May 2001 07:34:30 -0400 Jeff Werner <[log in to unmask]>
writes:
> 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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