Sampling and control in Fill & Finish

This activity presents the microbiological fundamentals required to understand risks in an aseptic environment, detailing microorganism types, contamination vectors, potential sources in a Fill & Finish setting, and principles of environmental monitoring.

This activity presents the main quality tests applied in the context of Fill & Finish, including sterility, bioburden, endotoxin tests and equipment controls. It also covers manual, semi-automated and automated visual inspection methods, along with the classification of critical, major, and minor defects on primary containers.

This immersive activity simulates the execution of a Media Fill Test in an isolator, reproducing the critical steps of aseptic connection, filling, equipment setup, and component handling, in compliance with the validation requirements for an aseptic process.