Questions and Answers on USP 797
RJLG Question 1: Question on fingertip sampling: I have a question regarding fingertip sampling. On page 34, the recommended action levels for microbial contamination states that the action levels for ISO Class 5 sampling is >3. Yet when I look at the appendix I for gloved fingertip sampling it states that "All employees shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (0 cfu) no less than three times before initially being allowed to compound CSPs for human use". I'm confused as to which one applies. Can you clarify for me? Thanks.
RJLG Answer 1: USP<797> clearly states that the initial competency evaluation and gloved fingertip/thumb sampling procedure does require 0 CFU for successful completion (performed at least three times) as quoted in your question.Table 4. Recommended Action Levels for Microbial Contamination, which shows >3 CFU as an action level for fingertip samples in an ISO Class 5 environment, applies to annual re-evaluation of compounding personnel who compound low and medium-risk level CSPs, and semi-annual re-evaluation for high-risk level CSPs. However, USP<797> states that the tables of recommended action levels are intended to be used as guidelines only, and “Action levels are determined on the basis of CFU data gathered at each sampling location and trended over time.”
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 Zock RJ Lee Group, Inc. 350 Fifth Avenue, Suite 5820 New York, NY 10118 (212)613-2709 mzock@rjlg.com
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