What must filter units used to sterilize Compounded Sterile Preparations also undergo?

Filter units used to sterilize Compounded Sterile Preparations (CSPs) must undergo integrity testing to ensure they are functioning properly and have not been compromised. Integrity testing involves assessing the filter's performance to confirm that it can effectively remove bacteria and other contaminants from the solution being sterilized. This step is critical because any breach or failure in the filter could allow microorganisms to pass through, risking contamination of the CSP and potentially leading to serious patient safety concerns.

Integrity testing is typically performed using methods like bubble point testing or diffusive flow testing, which help verify that the filter maintains its filter integrity. While routine cleaning, disinfection, and calibration are important practices in maintaining a clean and safe compounding environment, they do not specifically address the capability of the filter to perform its primary function of sterilization, making integrity testing essential for ensuring the safety and efficacy of the compounded products.