Container Closure Integrity Testing Method Development and Validation for Prefilled Syringes

摘要

Utilization of prefilled syringes as a preferred container closure system for biologies has been increasing [1]. As a primary container closure system, prefilled syringes must provide an integral barrier that protects drug product stability and sterility throughout its entire shelf life. Drug manufacturers are required to check and demonstrate the system is capable of maintaining its microbial barrier integrity [2, 3]. In 2008, FDA further promoted container and closure system integrity (CCI) testing as a component of the stability protocol for sterile products [4].