This article introduces a specialized negative pressure tester designed to assess syringe seal integrity under vacuum conditions, critical for ensuring drug stability and preventing leakage during storage or transport. The device simulates clinical vacuum scenarios to identify micro-leaks, complying with global medical device standards. Key features include adjustable vacuum levels, automated leak detection, and real-time data visualization.

Applicable Standards

Main Parameters

• Vacuum Range: -95 to -5 kPa (adjustable in 0.1 kPa steps)
• Leak Rate Sensitivity: 0.0001-0.5 mL/min (accuracy ±0.3% FS)
• Test Cycle Time: Customizable 5-300 seconds
• Data Output: USB/Ethernet with PDF report generation

Working Principle
  The tester creates a controlled vacuum within the syringe barrel using a precision pump. A capacitive pressure sensor monitors chamber pressure decay, while algorithms calculate leakage rates based on ISO 14644-1 standards. Automated valves isolate the sample during testing to prevent cross-contamination.

Test Principles

1. Vacuum Decay Method: Quantifies pressure loss over time under static vacuum
2. Mass Spectrometry: Detects helium tracer gas leakage (optional module)
3. Dye Penetration Test: Visual inspection under UV light (qualitative verification)

This integrated solution enables manufacturers to validate syringe integrity under extreme conditions, meeting ISO 13485 quality standards while ensuring reliable drug containment through rigorous negative pressure testing.