Prefilled Syringes: A Comprehensive Review of Design, Manufacturing, Clinical Benefits, and Future Trends

Prefilled syringes (PFSs) are increasingly used as primary packaging systems for parenteral drug delivery due to their ability to enhance medication safety, dosing accuracy, and operational efficiency. As drug–device combination products, PFSs integrate the pharmaceutical formulation with a delivery system that is ready for administration, minimizing preparation steps at the point of care. Their adoption has been particularly prominent for biologics, vaccines, and emergency medicines. Despite these advantages, prefilled syringes present unique challenges related to material compatibility, extractables and leachables, injectability performance, and regulatory compliance. This review provides a comprehensive overview of prefilled syringe technology, including design and components, manufacturing processes, clinical and operational benefits, formulation considerations, challenges and limitations, regulatory aspects, and future trends.