CLEANING VALIDATION PROTOCOL
The objective of this protocol is to define the cleaning validation studies and acceptance criteria for the cleaning (manual and automated) procedures used to clean the Liquid Filling line process equipment located in the Liquids Manufacturing Facility.
To demonstrate the effectiveness of cleaning procedures on the direct product contact surfaces, a worst case challenge is applied that will evaluate the most difficult to remove residuals from the most difficult to clean areas of the equipment surfaces.
This protocol will also aim to establish appropriate maximum holding times for dirty equipment prior to cleaning.