PUPSIT (Pre-Use Post-Sterilization Integrity Testing)
Single-Use Assemblies

We design and manufacture custom PUPSIT (Pre-Use Post-Sterilization Integrity Testing) assemblies engineered to meet the expectations of EU GMP Annex 1 and support modern viral clearance strategies. Each solution is tailored to your specific process, equipment, and risk profile—seamlessly integrating integrity testing without compromising sterility, efficiency, or operational performance.

Our single-use PUPSIT assemblies support multiple levels of automation that include fully manual configurations, semi-automated and fully automated systems. Manual assemblies provide flexibility for low-volume or development environments, while semi-automated solutions reduce operator intervention and improve repeatability. Fully automated PUPSIT assemblies enable inline testing, real-time control, and enhanced data integrity for high-throughput commercial manufacturing. Complete customization allows for compatibility with automated systems and capital equipment. 

By combining custom design, validated materials, an extensive library of sterilizing grade filters, and precision manufacturing, we help you implement PUPSIT in a way that aligns with Annex 1 requirements—strengthening contamination control, minimizing risk, and increasing confidence in filter integrity before filling begins.

---