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December 2003

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Subject:
From:
M Carroll <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 24 Dec 2003 09:18:15 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (85 lines)
My first question would be, Is the external consultant consulting on the
media fills? Because I've never heard any such recommendation. Three
GOWNING trials, with monitoring, yes. But standard practice has been
participation in at least ONE (1) successful media fill before being
allowed loose in aseptic operations, and minimum one per year thereafter-
not three. If you have a large operation, multiple fill rooms and lines,
and a large number of operators, you could dedicate 2/3 of your annual
production schedule to media fills and still never fully qualify
everyone. And I seriously doubt that any such requirement would raise the
assurance level of your aseptic operations, or raise anything else except
stress levels and costs.

M. Carroll
[log in to unmask]

On Mon, 22 Dec 2003 21:12:19 -0000 sean casey <[log in to unmask]>
writes:
> Hello all,
> We are involved in aseptic pharmaceutical manufacturing. I would be
> interested in your feedback regarding the training procedure for
> new
> primary aseptic operators.  We have been advised by an external
> consultant that new primary aseptic operators must participate in a
> minimum of 3 consecutive sucessful media fills per line prior to
> being
> allowed to independently perform critical aseptic line set up and
> interventions.
>
> Is this current practice?
>
> I would be grateful for your feedback
>
> Anne Casey
>
>
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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Microcheck - http://www.microcheck.com/
MIDI, Inc. - http://www.midi-inc.com/
Microbial ID, Inc. - http://www.microbialid.com/
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI Labs, Inc. - http://www.midilabs.com/
Millipore - http://www.millipore.com/
NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.com

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