usp class vi & fda materials

The Food and Drug Administration (FDA) has established a list of rubber compounding ingredients which tests have indicated are neither toxic nor carcinogenic. Rubber compounds produced entirely from those ingredients and which also pass the FDA extraction tests are said to 'meet the FDA requirements.' The FDA does not approve rubber compounds. It is the responsibility of the manufacturer to compound food grade materials from the FDA list of ingredients and establish whether they pass the necessary extraction requirements. Similar standards are established by the United States Department of Agriculture (USDA).

Additional requirements have been imposed upon seal manufacturers regarding food and beverage service. Parker has developed several materials that are certified to NSF 51, Food and Beverage Standard. In critical medical applications, seals often must be made from an even 'cleaner' list of ingredients. The U.S. Pharmacopoeia (USP) Class VI outlines requirements for system toxicity and intracutaneous toxicity for these 'cleaner' compounds. The USP Class VI compounds must be made from ingredients with clear histories of biocompatibility that meet tighter requirements for leachates.

Typical applications for our FDA, NSF 51, USDA materials are disposable medical devices, surgical instruments and medical fluid dispensing components, as well as a wide variety of food and beverage handling equipment. The type of approval/certification required generally rests with the end customer's regulatory expectations for the specific application.