Online-Seminar: Aseptic Process Simulation (Media Fill)

Zielsetzung

The seminar aims to provide a comprehensive understanding
of the regulatory requirements for aseptic process simulation (APS) across various dosage forms. Participants will gain
insights into critical aspects of the process, including vacuum control, ventilation, process step durations, and best
practices to optimize APS while avoiding common pitfalls.

A significant focus will be placed on quality and environmental protection measures, such as environmental monitoring during APS and recommendations for leak rate testing. Additionally, the seminar will cover essential topics on qualification and validation of rooms, systems, personnel, and processes, including RABS (Restricted Access Barrier Systems) and isolators, as well as airflow visualization and cleanroom class A qualification.

Participants will also learn about APS design and oversight, covering key factors like material formats, packaging materials, holding times, filling time, and bracketing considerations.

The target group includes pharmaceutical professionals directly involved in manufacturing or validation of aseptic
processes, quality assurance specialists, regulatory affairs managers, process engineers and developers, as well as technical leaders responsible for implementing and overseeing APS standards.