A Holistic Approach To CCI Is A Deterministic Approach

By Oliver Stauffer, PTI

Container closure integrity (CCI) sits at the center of sterile drug safety, yet managing its risks has become increasingly complex. Evolving container formats, advanced delivery systems, and shifting regulatory expectations now require a broader, lifecycle‑focused view of CCI. This holistic approach calls for understanding how design, material choices, manufacturing processes, and downstream controls interact to protect product quality over time.

A key takeaway is the growing role of deterministic testing, which offers measurable accuracy, supports scientifically justified sampling plans, and enables more frequent, non‑destructive checks. When combined with strong design principles, risk frameworks, and thoughtful in‑process control strategies, deterministic methods strengthen the foundation of modern CCI programs.

Explore how organizations can balance upstream engineering with downstream monitoring to maintain product integrity and meet today’s regulatory and operational demands.