Header Automation Processes

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).

Applications:

Feature 1

Media & buffer storage bags


Feature 2

Bioreactor bags


Feature 3

Cryo Bags


Feature 5

Aseptic transfer bags


Feature 6

IV & infusion bags


Feature 7

Multi-port single-use fluid transfer system


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)

Technical Specifications

  • 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

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