Improving the Cleaning Certification Process in the Manufacturing Area

Abstract

By addressing the shortcomings and inefficiencies in the present Cleaning Certification procedure used by biotechnology manufacturing companies, this project seeks to modernize and streamline it. The technique experiences lags and disconnects from vital systems like Manufacturing Execution System (MES) and Laboratory Information Management System (LIMS), impacting product release timing. The Define, Measure, Analyze, Design, Verify (DMADV) methodology is used in this project to thoroughly comprehend the current process, gather and analyze data, and create a digital platform that smoothly combines Manufacturing Execution System (MES) and Laboratory Information Management System (LIMS). The initiative aims to increase operational effectiveness, decrease waste, and maintain regulatory compliance by speeding up sample testing and automating the Certification process. A new age of excellence in biotechnology manufacturing is ultimately intended, which will redefine industry norms. Key Terms - Biotechnology Industry, Cleaning Certification, DMADV Methodology, and Lean Manufacturing.