Post by Bausch+Ströbel

A sterile filter is only safe if its integrity is verified in the exact condition in which it will be used. That is why PUPSIT has become a key expectation under Annex 1. 🔍 Transport, installation, and sterilization can damage filter membranes before production starts. In the past, integrity testing was often performed only after filling, despite the risk that product could mask even the smallest defects and distort test results. PUPSIT changes this approach. By testing filter integrity after sterilization and immediately before production, manufacturers gain significantly higher process assurance and product safety. 🛡️ The challenge is integrating PUPSIT into the filling process in a reliable and efficient way. We therefore integrate the complete filtration setup directly into the machine design, as close as possible to the point of use, inside or outside the isolator. Whether single-use assemblies, SOP, CIP/SIP systems, or single and double filtration concepts, every setup is application-specific and process-safe. ⚙️ Automated membrane wetting with product, WFI, or buffer solutions, combined with test methods such as Forward Flow, Bubble Point, or Water Intrusion Test, enables stable and reproducible processes directly before production starts. Full integration into the machine control system ensures continuous recording of test results, pressure, flow parameters, and complete batch documentation. 📊 The outcome: 🔺Increased process assurance before production starts 🔺Reliable Annex 1-compliant PUPSIT integration 🔺Automated and reproducible filter integrity testing 🔺Reduced product loss through optimized filtration design 🔺Full digital documentation and traceability Product safety does not start with filling. It starts with proven filter integrity before the first vial is filled. 👉 Learn more about our Annex 1-ready filtration solutions on our website or get in touch with our experts.