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Occasional Advisor
Posts: 9
Registered: ‎09-12-2011

Re-evaluation Sample Size for Personnel Gloved Fingertip Sampling

USP 797 is clear on the frequency for re-evaluation of personnel gloved fingertip sampling after initial competency based on low, medium, and high risk level CSPs. It is not clear on how many sample to collect during the re-evaluation of compounding personnel. Are we still suppose to take no less than three samples of both hands for re-evaluation of compounding personnel competency? Also, what is the CFU action level for both hands (gloves) during re-evaluation of compounding personnel competency? Will appreciate how other organizations are performing this competency and interpreting their test results.