In accordance with the updates made to USP 797 in 2020, how often should air sampling for Category 3 be done?

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Air sampling for Category 3, as outlined in the updates to USP 797 in 2020, is required to be done monthly. This frequency is essential to ensure that the environment in which sterile compounding occurs remains within acceptable limits for microbial contamination and other airborne particulate matter. Regular monitoring through monthly air sampling helps to identify any potential issues that could compromise the sterility of compounded preparations. It is crucial for maintaining compliance with safety and quality control standards that protect both patients and healthcare workers.

Daily, weekly, or annual sampling frequencies do not align with the updated guidelines, as they either do not allow for sufficient monitoring to catch potential contamination issues promptly or involve excessive sampling that may not be necessary for effective quality control in this context.

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