Container closure integrity (CCI) is central to ensuring product quality and patient safety. Our science- and risk-based approach integrates CCI across the full product lifecycle, from development to distribution. This white paper outlines how we apply industry-backed practices and proprietary technologies to proactively safeguard sterility and performance.
Key Highlights
- Lifecycle-Wide Quality Integration We embed CCI considerations into four critical phases: container closure system development, material qualification, drug product manufacturing, and distribution/storage. This holistic view ensures that integrity is preserved from early design through to patient delivery.
- Advanced Testing and Proprietary Technologies Our Drug Product Services (DPS) team employs deterministic methods such as helium leak testing—recognized for its sensitivity and regulatory favorability. We’ve developed proprietary fixtures for both vials and prefilled syringes (PFS), enabling precise, modality-specific testing.
- Modality-Specific Solutions: For products like mRNA therapies requiring ultra-low storage temperatures, we’ve engineered CCIT capabilities down to -80°C. Our platform also supports PFS-specific needs, including plunger displacement and sterile zone validation, ensuring compatibility with autoinjector systems.
- Faster, Safer Launches: By generating platform data early—often without drug substance—we accelerate time-to-clinic, reduce material usage, and streamline regulatory submissions. This proactive strategy minimizes technical risks and supports global compliance.