Author: Joe Maciejczyk
Design and fabrication specifications for pharmaceutical assets typically focus on sanitation sustainability with design conditions that can generate service-related defects often being overlooked. Understanding, discovering and mitigating service-related damage go hand-in-hand with sanitation goals since micro defects may harbor biological activity. Damage mechanisms typically take the form of thermal and mechanical fatigue. Ideally, the asset specifications should address these issues, but unknown or changed process parameters, temperature ramps, fabrication features, etc. may initiate unforeseen and undetected damage mechanisms. This presentation provides an overview of design specification and factory acceptance testing requirements to address unanticipated and unintended service damage. In addition, we will review in-service examination nondestructive testing and other program basics to discover and mitigate the impact of service-related damage.
Pillar 2: Equipment Reliability & Manufacturing Process Reliability