Aseptic Manufacturing using an Automatic Filling Line
You will work with an automatic filling line in a class A/B cleanroom. Before entering the classified areas, attention will be paid to cleanroom procedures and behavior in a GMP environment.
In the first production run, we will fill vials with water so you get to know the operational aspects of the machine. Then we get serious. The second production run is a media fill and requires routine interventions. A gowning qualification is part of the program. Using a visual inspection qualification batch, you gain a good understanding of the size and type of particles you could encounter in your own vials.
Naturally, the course focuses on environmental monitoring, for example by case studies and risk assessments. All results of media fill, environmental monitoring and visual inspection will be reported to the trainees.