This article presents a specialized positive pressure tester designed to evaluate the seal integrity of medical syringes under simulated clinical conditions. The device ensures compliance with international standards by measuring leakage rates under controlled pressure differentials, critical for preventing contamination and ensuring drug delivery accuracy. Key features include automated pressure regulation, real-time data logging, and multi-standard compliance.

Applicable Standards

Main Parameters

• Pressure Range: 0-600 kPa (adjustable in 1 kPa increments)
• Leak Rate Detection: 0.001-5 mL/min (accuracy ±0.5% FS)
• Test Duration: Programmable 1-999 seconds
• Interface: 4.3" touchscreen with USB data export

Working Principle

  The tester uses a pneumatic system to apply positive pressure to syringe barrels while sealing the plunger. A high-precision pressure transducer monitors decay rates, with algorithms compensating for temperature variations. Automated valves control test cycles, ensuring repeatable results across production batches.

Test Principles

1. Pressure Decay Method: Measures air loss over time under constant pressure
2. Mass Flow Detection: Quantifies gas leakage using thermal sensors
3. Bubble Emission Test: Visual inspection under submerged conditions (optional module)

This integrated solution enables manufacturers to validate syringe integrity efficiently, meeting FDA and MDR requirements while ensuring patient safety through robust seal quality control.