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May 2001

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From:
Scott Mackin <[log in to unmask]>
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Date:
Thu, 3 May 2001 09:37:18 -0400
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Carol,

     The sampling you discuss would be an advantage to your cleaning
documentation.  OOS recoveries could indicate contamination issues regarding
your Use Dilution formulations, or an improperly excecuted cleaning.  It
will also provide documentation of the efficacy of your housekeeping
protocols and personnel training.  Air cleanliness, as we all know, (and
unfortunately) does not always correlate to surface cleanliness.

Regards,

Scott Mackin
MicroTest Laboratories
800-631-1680, ext. 22

-----Original Message-----
From: The Pharmaceutical Microbiology Mail List
[mailto:[log in to unmask]]On Behalf Of Carol Lihs
Sent: Wednesday, May 02, 2001 4:11 PM
To: [log in to unmask]
Subject: [PMFLIST] RODAC plates


Greetings to all--

     Can anyone see the advantage to  doing RODAC plates on walls in a
packaging
area for a non-sterile solid oral dosage form?  I really think that air
sampling
would give more valuable results in this situation but I can't seem to get
my
point across.  I'm discussing this with some non-microbiologists who are (I
think) confusing  our packaging area with a Class 100 Clean Room.  Help,  I
really need some opinions from the experts.

          Carol Lihs
          Sr. Microbiologist
          GlaxoSmithKline


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