What Should Be Noted In The Process Verification Of The Final Cleaning Of Metal Orthopedic Implants?

The final cleaning process of metal orthopedic implants should be designed in accordance with the product structure and characteristics, production process, foreign substances that may be introduced during the process, and the hazards introduced by the cleaning process itself. The acceptance criteria for product cleanliness after final cleaning of products should be determined, and the corresponding basis for such determination should be clarified. The product families that can use the same cleaning process should be specified, and the cleaning process verification should consider using the products most difficult to clean in the product family for verification. The evaluation of product cleanliness can consider appearance, bioburden, bacterial endotoxin, organic contamination, inorganic contamination, cytotoxicity, particulate contamination and other aspects.