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Scientific Poster Download

Poster modified on 10/10/2024

Comparison of Direct and Indirect Container Closure Integrity (CCI) Testing Methods for Autoinjectors
Steven Ren, Yueming Sun, Yifan Mo, Jun Yan, Duoduo Zhang, Quanmin Chen, Shuying Ji*, Jeremy Guo*
Drug Product Development, WuXi Biologics

Container closure integrity testing (CCIT) is essential for ensuring the quality and safety of drug products throughout their shelf life. Regulatory authorities mandate that CCIT results be provided alongside sterility data. However, applying CCIT methods to pre-filled syringes (PFS) integrated into autoinjectors and other combination products presents challenges due to the rigid device shell. In this study, we explore specialized direct and indirect CCIT methods to address these complexities.

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