Thermo Scientific inSITE Integrity Tester for Single-Use Bioprocess Container Leak Detection

The Thermo Scientific inSITE Integrity Tester is a specialized point-of-use integrity testing system designed for biopharmaceutical manufacturing environments to verify the integrity of single-use bioprocess containers (BPCs). Utilizing sterile air, it detects both gross and fine leaks prior to BPC filling, ensuring reliability in critical molecular diagnostics and biomanufacturing workflows.

Key features include:

• Single- and multi-channel testing capability enabling simultaneous integrity verification of multiple BPCs, manifolds, and assemblies.
• Universal electrical compatibility allowing deployment regardless of geographic region, addressing global bioprocessing site requirements.
• On-board blower for full mobility and ease of use in different production settings.
• Integrated printer for immediate documentation of test results, enhancing traceability in GMP-compliant manufacturing pipelines.

Technical capabilities:

• Supports testing of BPCs up to 5,000 liters in volume, suitable for large-scale bioprocessing operations.
• Incorporates an inflation procedure to optimize container loading and placement within tanks.
• Features a liquid filling cycle that regulates internal pressure during fluid introduction to simulate real-use conditions.
• Equipped with an uninterrupted power supply delivering 10–15 minutes runtime to mitigate data loss during power interruptions.
• Includes guided validation setup to streamline compliance with regulatory standards in synthetic biology and bioprocessing environments.

This system is essential for biotechnology facilities focused on gene editing, synthetic biology, and molecular cloning workflows, where container integrity directly impacts product quality and process robustness. The inSITE tester is widely adopted in biopharmaceutical production pipelines requiring precise and reliable container integrity assurance prior to critical aseptic fill-finish steps.