Medzus | Auto injectors, Pen & Jet Testing
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Bench Testing

Luer Lock Adaptor Collar and Tip Cap Pull-off Force and Torques

Luer Cone Breakage Resistance

Luer Connectivity

Tip Cap Closure System Forces and Torques

Needle Penetration and Pull-out Forces

Burst Resistance

Flange Breakage Resistance

Break Loose, Extrusion and Lubrication

Deliverable and Residual Volume

Liquid Leakage Beyond Plunger and Fluid Pressure

 

Performance Related Shelf Life and Storage

Technical Investigations and Failure Root Cause Analysis

Residual Seal Force

Spike Penetrability

Fragmentation

Spike Retention and Sealing Capacity

Extractables and Leachables

Particle Analysis

Container Closure Integrity

CCIT Integrity Test

Scope of Standards

ISO 11608 -1: Needle-based injection systems Testing

ISO 11608 -3: Finished containers Testing

ISO 11608 -5: Automated Function Testing

 

ISO 11608 -2: Needles Testing

ISO 11608 -4: Pen Injectors Testing

ISO 11608 -6: On Body Delivery System Testing