West Presents: Critical Time- & Temperature-Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle

At the recent 2018 PDA Parenteral Packaging in Rome, Dr. Qingyu Zeng, Principal Scientist in the Scientific Insights Lab in Scientific Affairs & Technical Services, gave a presentation entitled Critical Time- & Temperature- Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle. This presentation gave an update on research that aims to provide fresh insights to the parenteral packaging industry.

By employing both testing evaluation and modeling calculations, research results demonstrate that container closure sealing performance has a critical nature of both time- and temperature-dependency. Discussion included how to develop a systematic approach to proactively and practically consider: design, set up, control, and management of stopper sealing performance. In addition, cosmetic vial assembly acceptance through proper considerations in container closure system (CCS) and capping processes was discussed.  These techniques are intended for the purpose of ensuring sufficient sealing performance throughout the entire sealed product life cycle.