Plunger Functional Suitability Tests
The plunger functional suitability tests address the functional suitability of systems with elastomeric plunger components. These systems also include cartridge and syringe systems. There are three definitions and terms that apply to the plunger functional suitability tests.
The following terms and definitions apply to the tip cap and needle shield functional suitability tests:
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Plunger Break-Loose Force:
The force required to initiate the movement of the plunger of a liquid-filled syringe or cartridge. -
Plunger Extrusion Force:
The force required to sustain the movement of the plunger to expel the contents of the liquid-filled syringe or cartridge. -
Plunger Seal Integrity Test:
Tests the ability of the plunger to maintain a fluid seal while under pressure.
Advanced Testing for Advanced Care
Specializing in plunger functionality, our tests assess the crucial force needed for smooth drug expulsion. We commit to enhancing patient care with syringes and cartridges that meet the highest standards of functionality and safety.
Early-Phase Development
Comprehensive packages designed to navigate clinical & regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.
Container Closure
Integrity Testing
Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.
Particulate
Analysis
Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.
Medical Device
Analysis
Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.
Extractables
& Leachables
Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.