Direct CCI Testing of Fully Assembled Autoinjectors Using Headspace Analysis
Day 2 Packaging & Device Innovation Stage
07/10/2026 15:45 - 16:10pm
Contributors
Cornelia Hain : Device & Packaging Development Lead - Polpharma Biologics Internation AG
Alessia Pacioni : Device Technology Lead - Polpharma Biologics International
Container Closure Integrity (CCI) is a critical quality attribute for maintaining sterility and product quality in combination products throughout their lifecycle.
This presentation explores current regulatory expectations and practical challenges associated with CCI, emphasizing its integration into design, development, and manufacturing processes. A validated, non-destructive method using headspace gas analysis for direct CCI testing of fully assembled autoinjectors will be presented as a case study.
The session covers method development, key validation parameters, and the advantages of deterministic testing approaches over traditional probabilistic sterility methods. Attendees will gain actionable insights into implementing robust CCI strategies that support GMP compliance, reduce sample waste, and enhance product safety across development, release, and stability testing.