Sartocheck® 5 Plus

The Sartocheck^® 5 Plus Filter Tester delivers comprehensive automated filter integrity testing capabilities spanning from small syringe filters to large multiround housings and tangential flow cassettes. This advanced system performs bubble point, diffusion, water intrusion, and pressure drop tests with program-specific Quality Risk Management parameters that automatically identify testing anomalies before and during tests, preventing time-consuming deviations and potential drug recalls.

Built on a custom Linux-based operating system, the device ensures ultimate data integrity with encrypted double-data backup, time zone-synchronized audit trails, and comprehensive role management. The four-eyes principle with electronic signatures maintains compliance with 21 CFR Part 11 requirements. The intuitive iF-Design award-winning interface features a 12.1-inch touchscreen with ±88° viewing angle, supporting 10 system languages and LDAP integration for seamless network credential access.

Designed for demanding GMP environments, the system provides IP64 splash protection and explosion-proof certification (ATEX/IECEx/FM) for safe operation with alcohol-wetted filters. VHP resistance and compatibility with all current cleaning agents support robust contamination control strategies. Optional automated pneumatic cleaning with up to 0.5 M NaOH at 50°C and external venting accessories enhance contamination prevention protocols.

The device accommodates sample volumes from 14 L (internal reference) to 150 L (external reference) with measurement accuracies of ±0.1% full scale for pressure and ±5% for diffusion/intrusion flows. Automation capabilities via OPC UA and Modbus TCP enable seamless integration into manufacturing control systems