From Residues to Risk: The Role of Cleaning Validation in Biocompatibility Assessments

Description

Cleaning validation and biocompatibility are distinct regulatory requirements—cleaning validation is designed to demonstrate that a device or component can be consistently and effectively cleaned to remove manufacturing residues or contaminants, while biocompatibility evaluates the safety of the finished device when in contact with the body. However, in select circumstances, data from a robust cleaning validation study may provide supportive evidence in the context of biocompatibility, particularly when assessing the impact of a manufacturing or supplier change. For example, if cleaning validation confirms that process residues are removed to well below toxicological concern, this information can help mitigate uncertainty about whether the change introduces new biocompatibility risks. While not a substitute for chemical characterization or toxicological risk assessment, cleaning validation can, in these cases, complement biocompatibility evaluations as part of a holistic justification.