ABSTRACT
This chapter focuses upon the approaches used to validate cleaning systems and processes in the biopharmaceutical industry. The validation of a cleaning process, like the validation of most manufacturing processes, is performed as a series of sequential steps. Each step should add value to the cleaning process, building upon the value of the previous step. The concept of cleaning consistency is then combined with the concept of cleaning effectiveness. The sequential approach used for the validation of a cleaning system and/or process is not unlike the approaches used for the validation of most processing systems. A cleaning master plan can be used to define how cleaning is accomplished and why, and the approach that will be used to demonstrate that the cleaning is consistently effective. Typically, a cleaning process validation study requires the development of a test protocol, execution of the protocol, analysis of data, and the establishment of conclusions based on this data.
