Without a successful aseptic process simulation, there is no basis for releasing the production line for aseptic filling

– Recognize the importance of the media fill.
– Training for individuals involved in the planning, execution, supervision, or evaluation of an aseptic process simulation, or who wish to gain insight into the complexity of a media fill.
– New Annex 1 of the EU GMP Guidelines with APS Aseptic Process Simulation

During the aseptic filling of medicinal products, a sterile product is manufactured under sterile conditions without terminal sterilization.

The purpose of simulating the aseptic manufacturing process by filling with nutrient media (media fills, APS Aseptic Process Simulation) is to demonstrate that the aseptic manufacturing process is under control and suitable for producing sterile medicinal products without terminal sterilization.

A successful media fill thus serves as evidence of product safety and is a prerequisite for authorization to manufacture aseptic products.

New Annex 1 with APS

Aseptic filling is one of the most demanding activities and is therefore considered a supreme discipline in pharmaceutical manufacturing. As its title suggests, the current Annex 1 focuses on the manufacture of sterile medicinal products and, in particular, on aseptic processing. Annex 1 now refers to the media fill as APS Aseptic Process Simulation.

During the media fill, APS Aseptic Process Simulation, the manufacturing procedures are simulated as accurately as possible.

This also includes simulating routine activities and “worst-case” interventions by personnel. The aim of every media fill is to achieve zero contamination. But what should be done if there are units showing turbidity? You will receive an overview of the evaluation criteria and how to handle deviations during the media fill.

Additional modules

– Aseptic filling: Fundamentals
– Aseptic filling: Personnel requirements