Cleaning Validation for Medical Devices: Establishing Cleaning Limits

September 5, 2018

After the potential hazardous contaminants from the manufacturing process have been identified during the review of the process flow, the acceptable levels for the contaminants is determined.   For contaminants with complete toxicological data available, follow ISO 10993-17 to set the cleaning limits for the contaminants.    When limited toxicological data is available, at a minimum the LD50 values can be used to calculate the cleaning limits.   For most contaminants the LD50 values are readily obtained from the MSDS.

The established cleaning levels are then used in the selection and evaluation of the cleaning test methods.