Test Methods and Quality Control for Prefilled Syringes

May 15, 2019
Cynthia A. Challener
Cynthia A. Challener

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2019, Volume 2019 eBook, Issue 1
Page Number: 14–19

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.

Read this article in Pharmaceutical TechnologyBiologics and Sterile Drug Manufacturing 2019 eBook

Article Details

Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing 2019
May 2019
Pages: 14–19

Citation

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).