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Empty and prefilled syringes must pass a range of quality control tests.
Before syringes are used on patients, they must go through rigorous quality control testing. Empty syringes must be tested at the site where filling will be completed as part of an incoming quality control protocol. Filled syringes are subjected to release testing.
Prefilled syringes can help reduce medication errors; however, the devices pose challenges in manufacturing and require extensive testing.
Knowledge and understanding of the various tests involved is essential for ensuring patient safety. A holistic approach to syringe manufacturing that includes formulation, process, packaging, device integration, quality control, and an understanding of the user needs is essential.
eBook: Biologics and Sterile Drug Manufacturing 2019
When referring to this article, please cite it as C. Challener, "Test Methods and Quality Control for Prefilled Syringes," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2019).