Aseptic processes are necessary in sterile product manufacturing, when terminal sterilization is not suitable, for example, because of intrinsic product features (heat-sensitive).
In pharma and biotech manufacturing, aseptic process simulation (APS), or Media Fill, is essential for validating aseptic processes, by demonstrating the maintenance of sterility during the activities.
As APS plays a crucial role in ensuring the safety and quality of sterile products, it is an increasing focus of regulatory requirements and inspections.
Media Fill runs should simulate as closely as possible the routine aseptic manufacturing process as well as the worst-case scenarios.
It is often challenging to interpret the regulatory requirements and understand how they can be applied practically.
This course aims to describe and address the crucial aspects to be considered in the design of an effective aseptic process simulation, including the risk-based approach, staff qualification, environmental monitoring, and cross-functional cooperation to build a robust and compliant successful APS program.