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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 3 Sep 2019 14:16:36 -0400
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Nikolina,

Exposing a settle plate during a testing session has value in confirming
environmental control with the LFH and good aseptic technique of the
analyst conducting the test. The results and the microbial identification
of any isolate may be useful in investigating an OOS result.

Tony

On Tue, Sep 3, 2019 at 2:00 PM Bači Nikolina <[log in to unmask]>
wrote:

> 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.
>
> [cid:image005.png@01D0918F.AD0D5F70]
> [log in to unmask]<mailto:[log in to unmask]>
>
>
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

------------------
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/


=================================
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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