Container Closure Integrity
US FDA (1999). Guidance for Industry: Container Closure Systems for
Packaging Human Drugs and Biologics
• It requires suitability of the selected container closure system be
sufficiently established in the four key aspects: protection, safety,
compatibility, and performance.
• Container closure integrity is considered an essential part of suitability,
especially in the aspect of protection against microbial contamination,
reactive gases (e.g., oxygen), and moisture.
• A container closure system that permits penetration of microorganisms is
unsuitable for a sterile product.
