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.
Stephen Parker, Microbiologist
This E-Mail and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. This communication may contain material protected by the attorney-client privilege. If you are not the intended recipient or the person responsible for delivering the E-mail to the intended recipient, be advised that you have received this communication in error and that any use, dissemination, forwarding, printing, or copying of this communication is strictly prohibited. If you have received this communication in error, please notify the sender immediately.
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.
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
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.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.