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September 2019

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Subject:
From:
Rick Jakober <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 3 Sep 2019 18:52:29 +0000
Content-Type:
text/plain
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Hi Nikolina,

We are a contract testing lab that specializes in non-sterile pharma microbiology. Our testing is performed in a biological safety cabinet that is monitored monthly and PM'ed and calibrated annually. In addition to our monthly active air sampling, we monitor the testing activities with an open TSA (SCDA) plate during all operations in the hood for sample prep and platings. We include one plate per campaign (or group of samples) and incubate that plate with the TAMC plates. Any colonies recovered on those plates would be used as a potential investigative tool for any growth noted during testing. So to answer your question we essentially do both.

Rick Jakober
Perritt Laboratories, Inc.

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Baci Nikolina
Sent: Monday, September 02, 2019 2:50 PM
To: [log in to unmask]
Subject: [PMFLIST] Monitoring of microbiological conditions in LF hood

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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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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