Container Closure Integrity Testing (CCIT) Challenge Kits

Annexe 1 of the EU GMP and the FDA Guidance on Container Closure Systems clearly emphasize the critical importance of robust container closure integrity (CCI) in ensuring the sterility and safety of pharmaceutical products. The revised Annex 1, released in 2022, strongly emphasises contamination control for sterile products and advocates for a risk-based approach to the design, testing, and monitoring of container closure systems (CCS).

Inline testing for real-time monitoring during production is essential. The key components of this framework include rigorous validation and qualification of CCS, regular performance reviews, and thorough documentation. Similarly, the FDA Guidance outlines precise requirements for CCS applicable to all drug products, including parenterals and biologics, emphasizing compatibility, sterility, and integrity throughout the product lifecycle.

With FTI's Container Closure Integrity Testing (CCIT) Challenge Kits , regulatory requirements of both the FDA and EU GMP are comprehended by ensuring the sterility and safety of pharmaceutical products. These kits are essential tools for validating the sensitivity and reliability of CCIT methods by simulating real-world defects in container closure systems (CCS).

These kits provided by FTI demonstrate that CCIT methods can reliably detect critical defect sizes, such as those that allow microbial ingress, ensuring compliance with sterility standards under 21 CFR Parts 211 and 610. Similarly, by using challenge kits to validate deterministic testing methods like vacuum decay, helium leak detection, and headspace analysis, CCS maintains an effective sterile barrier.