Aseptic process simulation (APS)

Also called a media fill: sterile growth medium is processed through an aseptic process in place of product, with the same equipment, people, interventions and durations, to show the process does not introduce contamination. Filled units are incubated, usually for 14 days, and inspected for growth. Under EU GMP Annex 1, the target is zero contaminated units, and the APS is repeated twice a year for each line, process and shift.