PMFLIST Archives

October 1999

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Subject:
From:
"Shih, Katherine" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 28 Oct 1999 17:20:30 -0700
Content-Type:
text/plain
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text/plain (55 lines)
1. At present, we are monitoring 1 minute for every 5 minutes throughout the
sterile fill operation. We are still exploring what are the optimal
practices.  If there is an excursion, the corrective actions should be
depended on the investigation results.

2. We set our counter for >5 um and >0.5 um, therefore, it is not possible
for us to compare the level of 5 um and the level of 0.5 um.

Katherine Shih
Oread


-----Original Message-----
From: Lorenzo Perilli [mailto:[log in to unmask]]
Sent: Thursday, October 28, 1999 7:04 AM
To: [log in to unmask]
Subject: [PMFLIST] Class 100 non-viable monitoring



        Dear Forum Members:

        I have a couple of questions concerning non-viable monitoring.
Specifically, monitoring of particles   in critical zones under class   100
laminar flow.

        1. What is your frequency of non- viable monitoring, and what
corrective actions are taken when       excursions occur ?
        2. During routine monitoring, has anybody experienced a higher
distribution of 5.0 um particulate
        when compared to the level of 0.5 um particles ? ( Both our Climet
particle counters were recently         calibrated)
        3. Finally, can anybody suggest any publications dealing with
non-viable monitoring ?



                Thanks for your contribution


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