Aseptic Process Design And Simulation Under Annex 1 Guidelines

The latest revision of EU GMP Annex 1 has transformed aseptic manufacturing by emphasizing risk reduction through design and robust contamination control strategies. This white paper explores how technologies like restricted access barrier systems (RABS) and automated isolators impact aseptic process simulation (APS), a critical validation step for sterile drug production. It details the differences in sterility assurance, operator interventions, and cleanroom requirements between these systems, while highlighting Annex 1’s prescriptive approach to APS design, including worst-case scenarios and intervention simulations. For manufacturers navigating Annex 1 compliance, understanding these principles is essential to ensure sterility assurance and streamline validation efforts.

Learn how Annex 1 shapes APS strategies and why isolator-based designs are becoming the gold standard for modern aseptic filling.