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How to Meet FDA Requirements in the Food and Pharma Industry

The Food & Drug Administration (FDA) protects public health by ensuring that companies that manufacture, distribute or import our food supply, medications, medical devices, radiation-emitting equipment, cosmetics, and animal products meet the strict requirements they have set forth.

The FDA’s stringent requirements call for a “super” bearing and seal materialin the food and pharmaceutical industry. It must be impervious, easily cleaned and have the ability to operate without galling or seizing without the help of oil, grease or other lubricants that may contaminate the food.

This super material is none other than impregnated carbon graphite.

MEeting FDA Requirements with Impregnated Carbon Graphite

Carbon graphite materials are employed in food processing equipment to ensure that foods are produced safely. These materials solve common problems that are often associated with traditional oil & grease lubricants – equipment failure and contaminated food.

Impervious to contamination, carbon graphite is considered the ultimate alternative solution. Its imperviousness results from impregnation with thermal setting resins, molten copper, molten bronze, or molten nickel chrome. Since there is no porosity in the material, there is no ability for bacteria to grow, a common issue in this highly regulated industry.

Carbon graphite is also self-lubricating, which is essential for the food and pharmaceutical industry. Since oil and grease lubricated metal bearings cannot be used when food processing equipment runs submerged in low viscosity beverages or liquefied foods, carbon graphite is, once again, the material of choice.

Obtaining GRAS Approval

FDA regulations regarding materials for use in food processing equipment are covered in the Code of Federal Regulations, Title 21. The FDA employs the acronym “GRAS” (Generally Recognized as Safe) to determine a product’s viability in the market. If a material is considered by the FDA to be GRAS, it means that it is generally recognized among quality experts to be safe under the conditions of its intended use.

Several grades of carbon graphite have been accepted by the FDA as GRAS, meaning that they have no FDA prohibited substances and are impervious to liquids.

Summary 

Revolutionizing the food and pharmaceutical industry, carbon graphite is employed by businesses to decrease costs, improve efficiency, and ensure public safety across one of the largest industries in the world.

Carbon graphite’s unique ability to withstand extreme temperatures, resist blistering and galling, self-lubricate, and increase the life span of parts while remaining sanitary and bacteria free makes it the material of choice for today’s largest operations.

If you’re interested in how carbon graphite can help improve your operation, get in touch today.

Contact Metcar for Information On Our FDA-Approved Materials