Automated Filtration System (AFS)

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

Discover your next automated filtration solution with our Automated Filtration System. Our cutting-edge technology 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 PUPSIT is under scrutiny

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 AFS ensures Annex-1 compliance and automates Pre-Use Post-Sterilization Integrity Testing and post-use integrity testing within a closed, single-use flow path, removing the manual valve manipulation and operator judgment calls that drive risk in a nonautomated system.

Benefits

• • Automated bubble point and/or diffusive flow testing, pre-use and post-use, within a single closed system
• • Reduced operator intervention during PUPSIT execution
• • Consistent, recipe-driven test execution across operators and shifts
• • Electronic test records supporting batch release documentation, supporting 21 CFR Part 11 compliant data trails, electronic batch, and test documentation
• • Compatible with Meissner’s existing filtration components, including Zebragard™ barrier filters and Single-Use Gauge Tee (SGT) pressure monitoring

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.

Talk with Meissner

Talk with Meissner about automating PUPSIT in your filtration workflow.