Automated Filtration System
PUPSIT skid

Q: What is the AccuFlux integrity testing and why is it important in the AFS?

The AccuFlux integrity testing technology is proprietary to Meissner Corporation and provides accurate bubble point and diffusive flow testing results in under 5 minutes. It also has a built-in false positive recognition feature that detects low flow conditions.

Q: What filters and single-use parts work with the AFS?

Meissner offers a range of qualified single-use filtration assemblies, including Zebragard PVDF membrane filters, TepoFlex single-use biocontainer bags and sample containers, and single-use gauge tees for pressure monitoring. Both normal flow and Tangential Flow Filters (TFF) with diffusive flow specifications between one to 250 mL/min or bubble points less than 90 PSIG are supported by the AFS.

Q: What are the dimensions of the AFS?

It's compact, measuring approximately 1.89 m tall, 1.24 m wide, and 0.8 m deep (including wheels), so it's easy to move around.

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
• Optimized for Meissner filtration and single-use solutions, including Zebragard^™ barrier filters, Single-Use Gauge Tees (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 AFS?

The AFS is a system that fully automates PUPSIT (Pre-Use Post-Sterilization Integrity Testing), a required step in Europe-based drug processing. It uses Meissner’s AccuFlux^® integrity testing technology, so you don’t need a person to run this test manually. It also keeps your batch records accurate and fully traceable.

What is the AccuFlux^® integrity testing and why is it important in the AFS?

The AccuFlux^® integrity testing technology is proprietary to Meissner Corporation and provides accurate bubble point and diffusive flow testing results in under 5 minutes. It also has a built-in false positive recognition feature that detects low flow conditions.

Do I have to automate PUPSIT?

No. Regulations like EU Annex 1 don’t require automation. However, it is strongly recommended, since it reduces human error and keeps your documentation more accurate and complete.

Can the AFS be customized?

Yes, it can accomodate up to two filters per skid, and you can adjust flow rates through a secure digital interface. Standard setups are available, and Meissner can also build custom configurations to fit your specific needs.

How does the AFS manage documentation?

The AFS uses 21 CFR Part 11 compliant software, meaning your batch records and audit trails are secure, accurate, and connected to your Supervisory Control and Data Acquisition (SCADA) system.

What filters and single-use parts work with the AFS?

Meissner offers a range of qualified single-use assemblies, which include Zebragard^™ PVDF sterile barrier filters, and TepoFlex^® single-use biocontainers (bioprocessing bags).

What are the dimensions of the AFS?

It’s compact, measuring approximately 6.2 feet (1.89 m) tall, 4.07 feet (1.24 m) wide, and 2.62 feet (0.8 m) deep (including wheels), so it’s easy to move around.