USP <797> guidelines require initial and annual competency assessments, which include a written exam, process validation, and media-fill aseptic technique testing. Mandated by USP <797>, media-fill kits are specially designed to test the aseptic technique of sterile compounding personnel. The kits require personnel to perform a series of complex CSP manipulations, with the fluid inside the CSP designed to grow bacteria if there has been a break in the person’s technique. Why is it important for the technician to undergo such rigorous testing? Why is it important to be retested annually?
