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September 2019

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Subject:
From:
Bači Nikolina <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 2 Sep 2019 18:50:16 +0000
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Dear forum members,
In our laboratory we test non-sterile pharmaceutical products in LF hood.
I'm interested, what frequency of monitoring of microbiological conditions (air/settle plates) under LF hood is sufficient/reasonable?

-          Should monitoring be performed in the sense of verifying that the LF hood meets its purpose at a certain frequency (eg. daily or weekly), together with regular annual or semi-annual requalification, or

-          should monitoring be carried out in order to confirm aseptic working conditions for each activity in the LF?

Additionally, if monitoring of each activity is required, what if it is necessary to weigh one or two samples at the end of the day, and activity lasts only few minutes?
Is it reasonable to carry out monitoring during such short activities if monitoring has already been carried out on the same day?


Thank you in advance!

Nikolina Bači
Head of Microbiological laboratory
Belupo d.d.

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