Medical Device Package Inspection

Medical device manufacturing is a labor intensive process, requiring operator involvement from manufacturing through final inspection of products. Unit costs are typically high for a variety of reasons, including design, regulatory compliance, specialized labor and unique equipment involved in the manufacturing process. Complementing the high cost of manufacture, there is also a high value placed on the sterility and quality of the final product. High product costs and superior quality requirements are the two single reasons for successful integration of airborne ultrasound seal inspection for medical device packaging. This case study focuses on the use of Seal-Scan® for final seal quality verification for an implantable sterilized medical device.