Keep in mind that non-sterile facilities are just what they say they are
--NON-STERILE-- and most environmental monitoring is only a "snapshot"
of the microbial bioburden at the time of sampling.  Here are some
references for you:

Reich, et al.  (2003) "Developing a Viable Environmental Monitoring
Program for Nonsterile Pharmaceutical Operations," Pharm. Technol.,
March, p. 92, 94, 96, 98, 100.

PhRMA Environmental Monitoring Work Group (1997) "Microbiological
Monitoringof  Environmental Conditions for Nonsterile Pharmaceutical
Manufacturing," Pharm. Technol., March, pp. 58, 60, 64, 66, 68, 70, 72,
74.

PDA Environmental Task Force.  "Fundamentals of a Microbiological
Environmental Monitoring Program", Vol. 44, Technical Report 13, Suppl.,
S3-S16, 1990.

Bob Friedel
[log in to unmask]

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Parker, Steve
Sent: Wednesday, May 03, 2006 8:22 AM
To: [log in to unmask]
Subject: [PMFLIST] General Environmental Practices Used in Non-Sterile
Facilities

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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the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

ATS Laboratories - http://www.ats-labs.com

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

Millipore - http://www.millipore.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

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