Prefilled Syringe Plunger Force Tester
This article presents a specialized tester designed to measure plunger force dynamics during syringe operation, critical for ensuring consistent drug delivery and patient safety. The device quantifies resistance forces under simulated injection conditions, complying with global medical device standards. Key features include adjustable injection speeds, real-time force mapping, and automated data analysis.
Applicable Standards
Standard | Focus Area |
---|---|
ISO 7886 | Syringe functional performance |
ISO 11608 | Sterile single-use syringe requirements |
USP <1> | Injections: Physical tests |
Main Parameters
- Force Range: 0-50N (resolution 0.01N)
- Speed Control: 5-200 mm/min (programmable profiles)
- Data Acquisition: 1000Hz sampling rate
- Output: PDF/CSV reports with force-displacement curves
Working Principle
The tester employs a motorized actuator to replicate plunger movement while a load cell measures applied force. High-resolution encoders track displacement, enabling calculation of friction coefficients. Software algorithms compensate for viscosity variations in test fluids, ensuring accurate force profiling across different media.
Test Principles
- Constant Velocity Testing: Measures force at fixed injection speeds
- Load Cycle Analysis: Evaluates force fluctuations during repeated plunging
- Break-Loose Detection: Identifies initial resistance during plunger activation
This integrated solution enables manufacturers to optimize syringe designs for smooth drug delivery, meeting FDA/CE compliance requirements while reducing injection-site complications through precise force characterization.