Addressing FDA Concerns in IV Drug Delivery
Recent communications from the U.S. Food and Drug Administration (FDA) have highlighted connection issues involving certain needleless prefilled glass syringes and intravenous drug delivery systems*. These concerns underscore the importance of reliable device compatibility in clinical settings, especially during emergency situations. In response to these challenges, Stevanato Group has developed an ITC syringe featuring an Enlarged Inner Cone (EIC), designed to improve compatibility with needleless access devices.
Market Evolution and Design Rationale
The intravenous (IV) drug market is increasingly shifting from traditional vials to prefilled syringes (PFS), driven by advantages such as ease of use, reduced contamination risk, and improved dosing accuracy. For pharmaceutical companies, transitioning to PFS formats offers differentiation opportunities.
Glass remains a preferred material due to its inertness and sterilization resistance, but compatibility issues with needleless access devices have limited its adoption in IV applications.
Technical Development and Standards Compliance
To address these issues, Stevanato Group redesigned the inner cone geometry of its ITC syringe to ensure compatibility with common Needleless Access Devices (NLADs).
The design verification process adhered to ISO 11040-4 for prefilled syringes and ISO 80369-7 for small-bore connectors. The syringe was tested for fluid and air leakage, axial load resistance, unscrewing resistance, and stress cracking. The inner cone dimensions fall within recommended ranges to support safe and effective connections.
Product Availability and Customization
The EIC syringe is validated with a five-year shelf life in both sizes 1.25mL and 2.25mL using existing ITC tip cap formulations. Additional formats, including 1mL, 1.5mL, 3mL, and potentially 5mL, can be developed upon request. Stevanato Group has filed a patent application for the inner cone design, and general specifications are available for customer evaluation.
Custom compatibility testing can be offered through Stevanato Group’s Technology Excellence Centers (TECs) which support pharmaceutical companies in defining robust testing protocols to ensure safety and efficacy.
Conclusion
By addressing known compatibility challenges and aligning with international standards, the ITC syringe with Enlarged Inner Cone offers a practical and reliable solution for intravenous drug delivery. This development reflects Stevanato Group’s continued commitment to supporting safe and effective healthcare practices through thoughtful design and patient centricity.
