(383e) Real Time Monitoring of Clean-In-Place (CIP) Operations in Manufacturing

Clean-In-Place (CIP) is a very important operation in Biotech/Pharmaceutical industries. Reliable and efficient CIP operations contribute to plant efficiency and product quality. However, the monitoring of CIP is complex as the process includes many logic sequencing steps, mechanical devices, and on-line measurements. Currently, detection and root cause analysis of subtle deviations is performed in univariate forms and requires significant subject matter expert time. Hence, organizations have to engage significant resources after the fact to investigate and document deviations.

Real time monitoring of CIP operations using Multivariate Data Analysis (MVDA) tools reduces the complexity of analyzing many on-line measurements by utilizing statistical models developed from historical CIP runs. Some challenges applying this methodology include the selection of informative variables, definition of phases, and proper data pretreatment. More details of the challenges, their solutions and the results of real time monitoring of CIP operations in manufacturing are presented.