What is the required frequency for surface sampling in Category 3 CSPs according to USP 797?

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The required frequency for surface sampling in Category 3 Compounded Sterile Preparations (CSPs) according to USP 797 is weekly. This is essential as Category 3 CSPs involve higher risk due to their complex requirements and the potential for contamination. Weekly sampling helps ensure that the sterility of the environment is maintained, allowing for the early detection of any microbial contamination.

Maintaining strict cleaning and monitoring protocols in a compounding area is crucial for patient safety, especially since Category 3 CSPs are prepared in less controlled environments than higher category preparations. The weekly frequency emphasizes the need for consistent vigilance in maintaining sterile conditions, thereby supporting the overall integrity of the compounding process.

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