IPI: Functional Testing of Prefillable Glass Syringes aligned with ISO 11040 Guidelines

Having a primary packaging container that serves both as sterile storage compartment and delivery device to administer drugs is the major driving force for the injectable combination products using prefillable syringes in a variety of applications. However, when it comes to the functional compatibility and delivery reliability between the syringe components (e.g., plunger, barrel, or closure cap) and the drug formulation, these benefits present more challenges than the traditionally used two-unit delivery systems vial and disposable syringe. Especially important properties like the gliding forces of the plunger or the flange strength need to be ensured over the entire shelf life. ISO 11040-4 defines a range of standardised test methods for prefillable glass syringes for the harmonisation of reliability within the industry. In this study, functional and strength tests according to the standards of ISO 11040-4 are performed, namely tests on flange breakage resistance, Luer-cone breakage resistance, needle pull-out force, gliding force, and pull-off force of closure caps. The results are statistically evaluated, thoroughly discussed, and the implications of the results for quality control are highlighted