Aseptic process simulation (APS)

A simulation of an aseptic manufacturing process in which sterile growth medium replaces the product and goes through the same steps, equipment and interventions; the filled units are then incubated and inspected for microbial growth. Because aseptically made products cannot be terminally sterilized and have no numeric sterility assurance level, the media fill is the main evidence that the process does not let contamination in. Japan's Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing, EU GMP Annex 1 and FDA guidance all expect it. Japanese documents also call it a media fill test or process simulation.