What Should Be Included In The Quality Control Of Processing Aids Used In The Production And Processing Of Orthopedic Implants?


2022-11-29

The administrative counterpart should fully consider the impact of processing aids on product performance during product design and development process. The quality control of processing aids should include at least the following contents: The use and selection basis of processing aids. Cleaning methods of processing aids, and the cleaning verification process. Controlling the residual processing aids of the product after cleaning. A study on the impact of residual substances on the safety and effectiveness of the final product. The acceptable limits of residual substances after final cleaning of the product should be discussed and demonstrated.