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May 2001


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Anthony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Wed, 9 May 2001 11:44:54 -0400
text/plain (57 lines)

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

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

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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