Probador de presión positiva de sellado de jeringas

Criterios aplicables

Parámetros principales

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

Principio de funcionamiento

  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.