Improve Vision System Seal Presence Inspection

Abstract

The sterile packaging of implantable medical devices is crucial for ensuring patient safety, preventing post-operative infections, and maintaining the integrity of the device until implantation. Given that these devices are placed within the body, contamination with harmful microorganisms can lead to serious complications, including implant failure and life-threatening infections. Sterile packaging acts as a barrier against pathogens, maintaining the sterility of the device during storage and transportation. Vision systems play a critical role in the sterile barrier inspection of implantable medical device packaging by ensuring the integrity and quality of the packaging, which is essential to maintaining sterility. In the manufacturing plant, inefficiencies in the packaging process, particularly in seal inspection, result in compromised product quality and potential contamination risks. Manual inspections and outdated quality control systems are prone to human error, leading to undetected seal defects, rework, and product recalls. In addition to the sterility issue, in the specific case being studied through this project, the sealing inspection inefficiencies create a productivity burden and operators’ burnout due to the extensive inspections. Key Terms - DMADV Method, Seal Inspection, Vision Systems.