This article presents a specialized tester designed to evaluate fluid flow characteristics through syringe tubing, critical for ensuring accurate drug delivery in medical devices. The system measures flow rates under simulated infusion conditions, complying with global medical standards. Key features include adjustable pressure settings, real-time flow monitoring, and automated data logging.

Applicable Standards

Main Parameters

• Flow Rate Range: 0.1-500 mL/min (±0.5% accuracy)
• Pressure Control: 0-300 kPa (programmable ramps)
• Fluid Paths: 1/16" to 1/4" ID tubing compatibility
• Data Output: XML/PDF reports with flow-pressure curves

Working Principle

The tester uses a precision pump to generate controlled pressure differentials across syringe-tubing assemblies. Inline flow sensors measure volumetric delivery rates while pressure transducers monitor system resistance. Software algorithms calculate flow impedance and identify deviations from theoretical performance models.

Test Principles

1. Steady-State Analysis: Validates consistent delivery under constant pressure
2. Pulsatile Flow Testing: Simulates physiological pumping conditions
3. Leakage Detection: Identifies micro-leaks through pressure decay monitoring

This integrated solution enables manufacturers to optimize tubing dimensions and material selections for precise drug delivery, meeting FDA 21 CFR Part 820 quality standards while ensuring patient safety through rigorous flow characterization.