Automated Filtration System (AFS)

Automated Filtration Steps, including PUPSIT, for single-use assemblies

Our Automated Filtration System ensures a seamless and rapid Pre-Use Post-Sterilization Integrity Test (PUPSIT) across a wide range of filter sizes, supporting both single and redundant filtration configurations in single-use closed systems.

Why automating PUPSIT is important

The 2022 revision of EU GMP Annex 1, in force since August 2023, made Pre-Use Post-Sterilization Integrity Testing the default expectation for sterilizing-grade filters. Integrity should be verified before use, in addition to the post-use test that has long been standard practice. Where PUPSIT isn’t performed, Annex 1 requires a documented risk assessment justifying the alternative. Annex 1 also calls for that testing to happen as a closed system wherever possible, and specifically encourages automation and robotics to remove direct human intervention from critical steps.

What AFS does

Our Automated Filtration System (AFS) ensures Annex-1 compliant automated Pre-Use Post-Sterilization Integrity Testing at point of final filtration, minimizing operator involvement and simplifying the transfer and final filtration of your products by seamlessly integrating with your single-use systems, linking the finished product tank and the filler.

Aligned with Annex 1, not just aware of it

The AFS is built around the same design space Meissner already applies to manual PUPSIT systems, extended into a fully automated workflow. For teams that still need a documented risk assessment for any manual step retained in their process, Meissner’s Validation Services Team can support that documentation directly.

Benefits

• • Efficiency by integrating automated testing, including bubble point and diffusive flow pre-use and post-use in a single skid (one single HMI, one single system)
• • Ease of Use through reduced operator intervention during PUPSIT execution
• • Consistent, recipe-driven test execution across operators and shifts
• • Accuracy of 21 CFR Part 11 compliant data trails, electronic batch records, and supporting batch release documentation.
• • Scalable capability with Meissner’s existing filtration components, including Zebragard™ barrier filters and Single-Use Gauge Tee (SGT) pressure monitoring
• • Space-saving compact PUPSIT or filtration systems with minimal footprint

Talk with Meissner

Talk with Meissner about automating PUPSIT in your filtration workflow.