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May 2001


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Jeff Werner <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Wed, 9 May 2001 07:34:30 -0400
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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

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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