Surface Sampling Inside a CACI

Questions and Answers on USP 797

* RJLG Question 7: If a CACI is used as the PEC (The gloves used are part of the equipment) is gloved fingertip sampling required? Is surface sampling required inside a CACI? If so how frequently?

* RJLG Answer 7:

All compounding personnel must undergo performance evaluations including gloved fingertip sampling. Your site-specific standard operating procedures should be modified for CACI use. Periodic surface sampling is required in all ISO-classified environments including a CACI.

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.

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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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For more information about USP 797, visit the USP 797 website: www.usp797.org.