USP <382> Functional Suitability & CCI Testing

USP <382> testing provides a complete evaluation of final packaged drug products to ensure they meet performance, safety, and regulatory expectations. Deterministic container closure integrity testing (CCIT)—including vacuum decay, helium leak detection, high‑voltage leak detection, and headspace analysis—supports validation activities, routine monitoring, and regulatory submissions. Functional suitability testing further examines how delivery systems perform under real‑world conditions, assessing penetration forces, self‑sealing capability, spike retention, sealability, syringe break‑loose and extrusion forces, plunger seal integrity, and the removal force or torque of caps, tips, and shields.

For complex or novel delivery systems, customized method development and rapid prototyping of test fixtures help ensure accurate and repeatable testing. These capabilities support a broad range of packaging formats such as vials, pre‑filled syringes, cartridges, autoinjectors, pen injectors, BFS containers, IV bags, and spike‑access systems. Whether for early development work, method validation, or full USP <382> strategy development, these services help teams reduce risk and optimize product readiness.