Equipment Validation Standardization for Project Implementation Time Reduction of Automated Manufacturing Platforms

Abstract

Abstract - Medical Device regulated industry requires extensive validation work. Using the latest automation technology for the process equipment to eliminate the operator interaction brings the challenge of how fast the company implements complex equipment requiring validations. After designing the manufacturing equipment of next generation products defining standard manufacturing platforms enables the standardization of requirements between systems. Nevertheless, Installation Qualification brings its challenges for the project timelines due to the nature of the requirements of this process. The project goal was to minimize the project timeline of the next generation product lines using the standard manufacturing platforms by improving the installation qualification process. The DMAIC methodology was used to organize information, delimit process scope, and gather the necessary information needed to make appropriate decisions. The results of the process improvements documented in this research showed an improved process with approximately 50% time reduction. Key Terms - Automation, Installation Qualification, Standard Testing Protocol, Equipment Automation.