Webinar
Break-Loose and Gliding Force Performance in Prefilled Syringe Systems
This on-demand webinar provides a comprehensive technical framework for understanding, evaluating, and optimizing break-loose and gliding force (BL/GF) profiles in prefilled syringe systems — covering FDA, USP, and ISO guidance on administration force testing, the five key elastomer selection factors that govern BL/GF performance, and NeoFlex™ spray coating data demonstrating consistent force profiles across shelf life at temperatures down to -50°C.
Status
Published
Format
Webinar
Language
English
Access
Registration Required
Resource Overview
About this Webinar
Break-loose and gliding force (BL/GF) profiles are among the most clinically significant functional performance attributes of prefilled syringe systems — yet regulatory guidance on what constitutes acceptable administration force is notably complex, with FDA, USP, and ISO each providing overlapping but non-identical frameworks for a product category that is regulated as a combination product under 21 CFR 3.2(e). This on-demand webinar provides pharmaceutical packaging, formulation, and device development teams with a rigorous technical framework for managing BL/GF performance across the full prefilled syringe system development and qualification lifecycle. Topics covered include the distinction between break-loose force (the force required to initiate plunger movement) and gliding force (the force required to maintain it through full dose delivery), and the patient safety implications of high, inconsistent, or unpredictable force profiles across patient populations including rheumatoid arthritis patients, multiple sclerosis patients, and juvenile patients with limited dexterity. Five key elastomer selection factors governing BL/GF performance are addressed in detail: interference fit calculation and FEA-based contact region analysis; elastomer coating selection comparing silicone emulsion, high-viscosity silicone oil, and NeoFlex™ fluoropolymer spray coating (which eliminates siliconization entirely); shelf-life consistency across sterilization methods and storage temperatures with 12-month data; rib and trim edge design optimization including undercut technology validated through FEA simulation; and cold storage performance with NeoFlex™ CCI and BL/GF consistency data confirmed at -50°C.
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