A Process Analytical Technology (PAT) Approach To Automated Container Closure Integrity Testing (CCIT)

By Andrea Simonetti

This article provides the overview of Process Analytical Technology (PAT) methodology application to an automated equipment developed for 100% Container Closure Integrity Testing (CCIT) of pharmaceutical items.

PAT is a scientific approach which is designed to facilitate continuous process improvement in terms of reliability, effectiveness and efficiency. PAT is based on process understanding and in particular it looks at the identification, determination and management of all critical sources of variability, so to guarantee that the expected quality is compliant with its requirements from the start ("right first time").

The CCIT, here referred to, is based on ASTM F-2338-09 “Standard Test Method for Non-destructive detection of Leaks in Packages by Vacuum Decay Method”; it is a proven integrity testing technology and it can be applied to all possible containers. CCIT, as all other physical processes, is affected by variability, resulting both in common and special causes. While common causes are predictable and removable through equipment improvements, special causes effects are intermittent, unpredictable and therefore can be mitigated through user direct actions only.