080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan

What this episode covers

Derek Duncan, Director and VP of Product Management at Lighthouse Instruments, explains the distinction between deterministic and probabilistic Container Closure Integrity (CCI) testing methods as defined in USP 1207. He details nine specific CCI technologies, including helium leak testing, headspace analysis, and vacuum decay, highlighting their sensitivity, destructiveness, and suitability for 100% production inspection. Duncan also clarifies the critical difference between CCI breaches, which pose sterility risks, and gas permeation through materials like rubber stoppers, which occurs over shelf life without compromising sterility.