Final answer:
Media fill tests for high-risk CSPs should be done at least semiannually, when a new facility is certified, with significant process changes, for new personnel, and for ongoing evaluations. Glove integrity testing is done at the start of compounding and periodically throughout.
Step-by-step explanation:
The question pertains to the best practices for ensuring the sterility and safety of Compounded Sterile Preparations (CSPs), particularly under high-risk conditions. Media fill tests, also known as sterility tests, are designed to simulate the compounding process using a microbial growth medium instead of the actual drug product. This test is essential for validating the aseptic technique of the personnel and the environmental conditions during the compounding process. Glove integrity testing, or glove fingertip sampling, evaluates the cleanliness of the gloves used in compounding and the competency of the individual in maintaining sterility.
According to the USP Chapter 797, media fill testing should be performed at least semiannually (every six months) for personnel who compound high-risk level CSPs. It should also be carried out when a new cleanroom or compounding facility is certified, when significant changes are made to the compounding process, when personnel are newly hired, and as part of ongoing personnel competency evaluations. Glove integrity testing should be done at the beginning of each compounding session and periodically throughout the compounding process to ensure ongoing sterility.
In summary, the media fill and glove tests for high-risk CSPs are critical components of the quality assurance process to maintain patient safety and medication efficacy.