Container Closure Integrity: Regulations, Test Methods, Application – Regulatory Requirements

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.