Expert Support For Container Closure Integrity

Ensuring container closure integrity (CCI) is critical for life science products to meet stringent regulatory standards and maintain patient safety. Advanced deterministic methods, aligned with USP <1207>, Annex 1, and ASTM guidelines, provide inspection-ready solutions that minimize risk and accelerate compliance. From initial recipe creation to full GMP-compliant validation, expert-led programs define robust parameters, establish system suitability, and deliver reproducible results. Services include method development, validation, and helium leak testing with ultra-sensitive detection—even at cryogenic temperatures—supporting R&D, QC, and material selection. Dual Centers of Excellence in New York and Switzerland ensure global continuity and regulatory assurance.

Explore how optimized CCI strategies can safeguard product integrity and streamline compliance.