Automated Filtration System
PUPSIT skid

Automated Filtration System (PUPSIT Skid)

Single-Use Automation Automated Aliquoting Automated Filtration/PUPSIT

Automated Filtration System (AFS)

Automated Filtration and Integrity Testing, including PUPSIT, for Single-Use Systems

The Automated Filtration System (AFS) automates pre-use post-sterilization integrity testing (PUPSIT) and post-use integrity testing within a closed, single-use workflow, supporting both single and redundant filtration configurations. Designed for sterilizing-grade filtration applications, AFS helps manufacturers improve process consistency, strengthen contamination control strategies, and support compliance with EU GMP Annex 1 expectations.

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 Delivers

AFS standardizes critical filtration and integrity testing steps, including PUPSIT, by removing manual valve manipulation and operator judgment calls that drive risk in non-automated systems. The resulting recipe-driven automation delivers repeatable execution, enhanced process control, and comprehensive electronic documentation across operators, shifts, and manufacturing sites.

Key Benefits

• Automated bubble point and/or diffusive flow testing for both pre-use and post-use integrity verification within a single closed system
• Reduced operator intervention during PUPSIT execution
• Consistent, recipe-driven test execution across operators and shifts
• Electronic test documentation that supports batch release and regulatory compliance requirements, including 21 CFR Part 11 data management frameworks
• Enhanced process control through automated workflow execution and digital guidance
• Secure electronic records supporting data integrity, traceability, and audit readiness
• Compatibility with Meissner filtration and single-use solutions, including Zebragard™ barrier filters, Single-Use Gauge Tee (SGT) for pressure monitoring, and biocontainer and tubing assemblies for secure fluid management.

Built for Modern Filtration Operations in Alignment with Annex-1

By combining automated integrity testing, digital workflows, and electronic documentation in a single solution, AFS provides a practical path to greater process control, operational efficiency, and confidence in filtration performance.

Frequently Asked Questions

What is the Automated Filtration System (AFS) for PUPSIT?

The Meissner AFS is a platform that conducts Pre-Use Post-Sterilization Integrity Testing (PUPSIT) by automation using Meissner’s popular AccuFlux^® integrity testing technology, removing the need for a human operator of this necessary step in downstream drug processing. Automation software also guarantees complete batch record accuracy and traceability.

Is automation for PUPSIT required?

No, automation is not required according to regulatory guidelines such as EU Annex 1, but it is highly encouraged to minimize operator error and ensure accuracy of batch records and complete documentation.

What single-use systems and filters can be used with the AFS?

Meissner has a comprehensive array of Single-Use Redundant Filtration (SURF) assemblies that have been qualified and optimized for use with the AFS, including the unique Zebragard™ PVDF membrane barrier filters, single-use biocontainer bags (TepoFlex^®) and sampler containers, and single-use gauge tee pressure monitoring.

Is the AFS PUPSIT skid customizable for my needs?

Yes, the AFS is easily configured to handle up to two filters (SURF) per customer need, and flow rates are adjustable through a flexible but secure digital interface. While standard single-use assemblies are available, Meissner also offers customization to meet specific customer requirements.

How does the AFS handle documentation?

The AFS provides 21 CFR Part 11 compliant software for batch records and secure audit trails linked to each customer’s Supervisory Control and Data Acquisition (SCADA) system, ensuring accuracy and traceability.

How big is the AFS?

The AFS is highly compact, measuring only 6.20 ft (1.89 m) tall, 4.06 ft (1.236 m) wide, and 2.62 ft (0.8 m) deep, inclusive of the caster wheels for easy mobility.