White Paper: Cleaning Validation For Medical Device Manufacturing

Cleaning validation is the documentation that establishes that a cleaning process will consistently result in devices that are clean to an acceptable level of cleanliness. In the medical device manufacturing industry, cleaning validation is generally performed by examining the finished device rather than the process equipment used to manufacture the device.

Validation concerns vary across the industry and are dependent on the class of medical device being validated. Devices are classified according to the nature of patient contact. Re-usable examining devices, with incidental patient contact, might be tested for function, protein and endotoxin (pyrogen) contamination. Whereas, implantable medical devices, with years of potential internal patient contact, might also be tested for full biocompatibility, residual toxicity and proper device function.

The objective of validation is to ensure product, patient, worker, and environmental safety. To meet this objective, typically you have a validation committee comprised of:

• Validation Specialist, writes and coordinates the procedure
• Manufacturing, writes SOPs and provides training
• Quality Assurance/Control, approves and implements analytical methods
• Engineering, communicates changes and evaluates equipment data
• R&D, performs recovery studies, validates methods, transfers methods, and selects new cleaners