PMFLIST Archives

May 2001

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
"Stanek, James" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 16 May 2001 09:18:31 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (82 lines)
All,

Since inspection agencies want to have vials that would normally be culled
during a product fill for defects incubated as part of media challenge, how
would the interpretation of those results be handled?  Could those of you
who incubate these defected units share how they are interpreted in relation
to the media challenge.

Jamie Stanek
Control Monitoring
Merck & Co., Inc.
Mail Stop:  WP29M-8
Phone: 215-652-2767
FAX:    215-652-7581
+ Be a LifeSaver!  Give Blood! +


-----Original Message-----
From: Jeanne Moldenhauer
[mailto:[log in to unmask]]
Sent: Sunday, May 13, 2001 10:05 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Media Fill Practice


I am personally aware of at least three different companies that were
forced by the Agency to incubate units that failed visual inspection.
The interesting thing is that no one tells them in advance whether a
failure of these units which are documented to be non-integral count as
a failure of the media fill or whether the unit is like a no test, where
it fails but doesn't invalidate the test.

Jeanne Moldenhauer

Jeff Werner wrote:
>
> 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
>
> ------------------
> The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
> The Microbiology Network (http://microbiol.org) and supported by
> our sponsors (http://microbiol.org/sponsor.htm) as a service to
> the scientific community.


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.



ATOM RSS1 RSS2