How Automation Can Facilitate Annex-1 Compliance in Final Filtration

WEBINAR

In this webinar, you will learn:

• How Annex-1 requirements impact Final Filtration operations, focusing on PUPSIT implementation
• Why Single-Use assemblies can reduce patient and business risks
• How an automated system can optimize product recovery and your facility layout

Final sterilizing filtration is the last unit operation assuring the sterility of medicinal products for human use. Single-Use platforms are increasingly adopted in all bioprocessing which requires a holistic approach to assure sterility of the system that encompasses both filters and components. EU GMP Annex-1 lays out the requirements to perform integrity tests on the sterilized filter assembly before (PUPSIT) and after use and highlights the increased amount of complex manual operations that needs to be carefully assessed.

This webinar focuses on aspects of new products and system design that help biomanufacturing customers meet the regulatory requirements and become an essential part of the contamination control strategy. Our offering maximizes product recovery at minimized operator risk and equips your drug product facilities with tailored process intensification technologies.