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May 2006

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Subject:
From:
"Parker, Steve" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 3 May 2006 08:21:57 -0400
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Forum,

 

I would like to re-post this to the Forum since it did not generate any
responses. I would like to see what type of testing, the frequency of
testing, etc., going on in other non-sterile facilities.  It is very
interesting to see what other Pharmaceutical Companies are doing,
especially in the non-sterile facilities.  I am a microbiologist in a
non-sterile manufacturing site.  We manufacture solid oral dosage
products as well as creams and ointments.  I would like to ask everyone
what are their practices for Environmental Monitoring in their
facilities.  To be more specific, what is the frequency for monitoring
their production/packaging areas for air and surfaces?  What is the
general procedure(s) used for cleaning validations for equipment and
rooms?  What is being done throughout the industry (non-sterile) for
monitoring compressed air?  (I see that this is a current topic, which
has prompted these questions.)  Also, can a facility use historical data
to qualify the use of disinfectants/cleaning agents?

 

Thank you in advance for your responses.

 

Regards,

 

Stephen Parker, Microbiologist

 

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