Automation of Final Test Station in the Manufacturing Process of a Medical Device Facility

Abstract

The IS-4 Final Test Station will incorporate the entire test needed to assure that the leads that are manufactured in Boston Scientific are built with a high quality standard that will assure the safety of the patient. The leads are an important component of a final medical device which includes an active pharmaceutical ingredient. Currently, the tests performed by the IS4 Final Test Stations are seal tests, leak test, resistance test and electrical tests. The electrical test will allow the operator acknowledge that electrical continuity is followed during the entire coil, in that way it can be assured that the coil is not internally broken. During the seal and leak tests an air pressure is introduced to the coil by an equipment component, and the equipment will measure the pressure at the other end of the coil to see if a leak is occurring in the coil. Key Terms - Coil, Electrical Continuity, Lead, Patient.