Questions and Answers on USP 797
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RJLG Question 2:
What is the minimum time
for a settle plate sample. We are currently using 15
min is this enough.
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RJLG Answer 2:
Although some still use
settling plates to qualitatively assess viable
airborne microorganisms, this method is not adequate
for quantifying airborne microbial burden in clean
environments such as ISO classified hoods (clean
benches, BSCs, CAIs), buffer or clean rooms, or ante
areas. Your USP 797 sampling plan should include
active air sampling using appropriate electronic air
sampling equipment and trained personnel. For more
information you may refer to Environmental Viable
Airborne Particle Testing Program under USP<797>
Pharmaceutical Compounding – Sterile Preparations, and
Methodology and Instrumentation for Quantitation of
Viable Airborne Microorganisms under USP<1116>
Microbiological Evaluation of Clean Rooms and Other
Controlled Environment.
Answer provided as a courtesty to usp797.org, inc. by RJ Lee
Group, Inc. (RJLG) and/or associates of RJLG. We assume
no liability for the use or interpretation of this
information. Please note that usp797.org, inc. is not
responsible for this answer.
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Matthew
Zock is an industrial hygienist with the technical
consulting services group at RJ Lee Group, Inc. Mr. Zock
provides a variety of industrial hygiene, health & safety,
and environmental consulting services for heath care,
general industry, and litigation support. He manages
RJLG's USP 797 services including environmental sampling
(microbial), hazardous drug monitoring, and facility
design and operation audits. Mr. Zock received his
Bachelors in Biology from Clarion University of
Pennsylvania, and his Masters in Environmental and
Occupational Health Sciences from Hunter College. He can
be reached as follows:
Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com
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