Questions and Answers on USP 797
RJLG Question 2: What is the minimum time for a settle plate sample. We are currently using 15 min is this enough.
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 courtesy to USP797.org 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 is not responsible for this answer.
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 ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com
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