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Single Use Bag Leak Tester:
LT-5000 FlexiTest
“Ensuring Integrity in Every Single-Use Bag”
- Single-use bags are widely used in pharma & biotech for media storage, transport, and critical sterile operations. Ensuring their integrity is essential for patient safety and regulatory compliance.
- Infinity’s LT-5000 FlexiTest platform provides advanced, non-destructive leak testing solutions specifically designed for single-use systems (SUS).
Key Features
- Non-destructive leak detection – no product loss
- High sensitivity – Detects micro-leaks in µm range
- Rapid test cycle – <60 sec typical
- 21 CFR Part 11 compliance (audit trail, user management, e-signature)
- Scalable – small R&D bags to large manufacturing bags (up to 200 L)
- Customizable fixtures for different bag designs
- Connectivity – OPC UA/DA, Ethernet, Wi-Fi for pharma IT integration
Technical Specifications:
| SPECIFICATIONS | MICRO LEAK DETECTION |
|---|---|
| Test Method | Vacuum decay / Pressure decay |
| Sensitivity | Down to 1 µm defect (depending on size & volume) |
| Accuracy | ±0.075% FS with Setra/Festo sensors |
| Bag Sizes | 50 mL to 200 L |
| Control System | 10” touch HMI, Windows-based |
| Data Handling | Crystal reports, LIS integration, remote monitoring |
Applications:
Media & buffer storage bags
Bioreactor bags
Cryo Bags
Aseptic transfer bags
IV & infusion bags
