(705a) Routine Process Monitoring for Automated Clean-in-Place Systems

While manufacturing process monitoring is of widespread use in the pharmaceutical industry, there are few examples where these principles are applied to cleaning processes, despite their criticality in preserving product quality and ensuring the reliability of product supply. The level of automation in modern manufacturing facilities, supported by automated cleaning- in- place (CIP) systems, provide for the continuous assessment of the performance of the cleaning process. This work describes a routine process monitoring (RPM) approach applicable for a fully automated CIP processes. A risk based approach for the screening and identification of key cleaning parameters for the establishment of a RPM Program will be discussed. RPM enables the transition from a reactive to a proactive approach for the monitoring of cleaning processes. Examples where RPM tools provide for minimizing equipment down time and strengthening of a cleaning validation lifecycle approach will be presented.