Aseptic Process Simulations: Designing and Evaluating Media Fills

This course helps teams design and evaluate media fills that meaningfully challenge aseptic operations, address contamination risks, support operator qualification, and provide evidence that the process remains appropriately controlled. Aseptic Process Simulations (APS), commonly called media fills, provide evidence that aseptic processing can be performed with minimal contamination risk when sterile drugs are filled into sterile containers. By replacing product with growth medium, the simulation challenges the process and the operators performing critical activities. Regulators use APS results to assess whether the aseptic process and personnel remain under appropriate control. Effective media fill design requires deliberate choices about interventions, worst-case conditions, execution frequency, participating operators, growth media, filling line speed, and evaluation of incubated units. This webinar addresses how these elements should be incorporated into an APS and how contamination risks should influence simulation design. Participants will also consider the use of media fills for operator qualification and the proper examination of units after incubation. The focus is on designing and evaluating periodic simulations that provide meaningful evidence of aseptic process control.