A Novel Process Analytical Technology Approach to Automated Pharmaceutical Container Closure Integrity Testing

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").