Changeover Reduction Time by Adjusting the Cleaning Critical Parameters in Automated CIP Systems

Abstract

Clean-In-Place (CIP) is a widely use process to clean biotechnology vessels contact surfaces. CIP is an automated cleaning method that involve minimum to no equipment disassembling thereby reducing labor and time expense. CIP provides higher level of repeatability and safety when the process is optimized. The objective of this project was to reduce the changeover time by determining where are the wastes in the cleaning process and campaign changeovers in the pharmaceutical manufacturing that are reflected as effective design of the automated CIP systems, avoid build up overtime, and manual cleaning of small parts. In field-testing were performed under combination critical parameters to clean the manufacturing vessels to acceptable limits. Different combinations were tested and samples once the cleaning process where completed. Data was statistically analyzed to visualize the reduction time based on the critical parameter adjustment. The goal was to not rework the equipment with the optimal CIP condition, which will lead to the changeover reduction time and compliance satisfaction. Key Terms - Automated CIP, CIP skids, Critical parameters, TACT