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.

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 

Analytical Method Development

Analytics

Aseptic/Sterile Processing

Biologic Drugs

Contract Manufacturing, Sterile, Aseptic Processing

Development

Dosage Forms

Drug Delivery

Fill-Finish

Formulation and Drug Delivery, Combination Drugs

Manufacturing

Manufacturing, Parenterals and Injectables

Manufacturing, Vaccines

Parenterals

Quality Systems

Regulatory/GMP Compliance

Regulatory/GMP Compliance, Europe

Pharmaceutical Technology-05-15-2019

Empty and prefilled syringes must pass a range of quality control tests.