Challenging our aseptic skills using more-rigorous media-fill tests

The current process to create compounded sterile preparations involves employing fallible (and microbially contaminated) humans who attempt to perform flawlessly and with perfect aseptic technique. This is not a reasonable or attainable expectation to have of our compounding personnel. There are many sources of microbes that can lead to nosocomial infections and patient sepsis, not all of which can be directly addressed.1,–3 However, we can minimize the dangers of the sterile compounding process as a source of contamination through the use of robust work practices, which must include the rigorous disinfection of critical sites and the use of sterile gloves and sterile alcohol. Pharmacists and other compounding personnel have a duty to their patients to make use of these practices. These practices, which are detailed in United States Pharmacopeia chapter 797, include annual or semiannual intervals of didactic training and testing, gloved fingertip sampling, an aseptic media-fill test (with no demonstrated microbial growth), and observational assessments of hand washing, garbing, and aseptic technique. The aseptic media-fill test is one of the most widely used tools to evaluate the aseptic technique of compounding personnel. Media fills should simulate actual aseptic operations as closely as possible. All manipulations, handling, environmental conditions, and other factors likely to influence the risk of process-associated microbial contamination should be represented by the media-fill simulations. The intensity of such challenges should represent the greatest risk that would be expected during normal production.