Single-Use System Integrity Tester

Intuitive Operation Interface: Equipped with a 10.4-inch industrial-grade touchscreen, it supports one-click parameter setting and real-time status monitoring, eliminating the need for professional operation experience.

Dual Independent Test Ports: Configured with separate test channels, it enables simultaneous detection of multiple single-use system models, effectively improving testing efficiency and reducing waiting time.

Strict Regulatory Compliance: Fully compliant with 21 CFR Part 11, GAMP5 guidelines, and GMP production standards, with complete audit trails and electronic signature functions to meet global regulatory requirements.

High-Precision Detection: Built-in pressure and temperature monitoring modules, ensuring accurate detection of system tightness and avoiding false test results caused by environmental factors.

Flexible Configuration: Compatible with various specifications of single-use systems, supporting quick switching of test parameters without additional equipment modification.

Comprehensive Data Management: Automatically records test process data, generates detailed test reports, and supports data export for regulatory submission.

Integrity verification of single-use storage bags in biopharmaceutical manufacturing

Airtightness testing and leak inspection of single-use bioreactor assemblies

Integrity validation of cell factories and disposable culture consumables

Routine tightness testing during API production and biological reagent processing

Pilot scale and small-batch production quality control for pharmaceutical disposable systems

Regulatory-compliant integrity testing for GMP-grade biomanufacturing facilities