Tribology - FDA approval

Lars Pleth Nielsen

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Tribology - FDA approval

In cooperation with the acknowledged U.S. Food and Drug Administration (FDA), the American body responsible for approval of food and drug contact materials, the Tribology Centre at Danish Technological Institute has reviewed our commercial chromium nitride (CrN) and diamond-like carbon (DLC) coatings. FDA considers the use of the Tribology Centre’s CrN and DLC coatings in connection with food and drug processing acceptable.

FDA also accepts the use of the coatings for injection moulding or other moulding processes, e.g. on tools for manufacturing plastics, metal and cardboard packaging for food and medical applications. The evaluation was conducted by the Food Contact Notification Division under Section 409 of the Federal Food, Drug and Cosmetic Act.

The recognition of our coatings is not surprising. The Tribology Centre’s DLC and CrN coatings have already successfully been used on equipment and tools for manufacturing of drugs, medical equipment, food processing equipment and packaging. For several years, the coatings have thus been used by many of the largest food and drug manufacturers in and outside Denmark.

We have long and positive experience ith the coatings and ongoing toxicity studies and therefore, it is also very satisfying that we have now received FDA’s acceptance of applying CrN and DLC coatings for food and medical applications. It is a fact that more and more customers are demanding FDA approval of contact materials for food production and drug applications.

If you have any questions or need further elaboration on the details of the use of our coatings, we are of course at your service.

 

Read more about the Tribology Centre's products.