Sponsored by:
Industry-backed data-driven approaches to enhancing container closure integrity
Strengthen Container Closure Integrity Across the Drug Product Lifecycle
Maintaining container closure integrity (CCI) is essential to ensure the safety, quality, and efficacy of sterile drug products. With increasing regulatory expectations and product complexity, manufacturers must move beyond traditional end-point testing and adopt a lifecycle-based approach to CCI.
Lonza applies an industry-backed, data-driven strategy that integrates CCI across drug product development, manufacturing, and distribution.
Why Container Closure Integrity Matters
Sterility failures remain a leading cause of drug recalls worldwide. With increasing regulatory scrutiny such as the expanded requirements of EU GMP Annex 1 container closure integrity can no longer be limited to release and stability testing alone.
Key Benefits of a Holistic CCI Approach
- Early identification and mitigation of CCI risks
- Reduced likelihood of sterility-related recalls
- Strong alignment with FDA and EU GMP Annex 1 expectations
- Lower drug substance usage through platform-based data
- Faster progression from clinical development to commercialization
A comprehensive, science-based approach to container closure integrity is essential for reducing risk, meeting regulatory expectations, and enabling successful drug development and commercialization.
