Investigation of the Application of Process Analytical Technology for a Laser Welding Process in Medical Device Manufacturing

摘要

In FDA regulated medical device manufacturing, real time inspection of manufactured product is limited by the requirement to destructively test random samples of the product post production. Infra Red thermography offers the ability to non-destructively test, key critical to quality attributes of medical devices during laser welding and facilitates real time statistical process control for enhanced product quality and yield. This paper will present results of research work focused on non-destructive methods using Infra Red Thermography to potentially replace destructive methods of assessment for laser welded joints in stent delivery catheters. The approach utilizes designed experiments in conjunction with IR assessment and also identifies some limitations of the proposed method.