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How to Meet FDA Requirements in the Food and Pharma Industries

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 their strict requirements.

The FDA’s stringent requirements have been put in place to protect public safety. There are regulations in place to make sure critical pieces of equipment help companies achieve that goal. One of their requirements calls for an extraordinary bearing and seal material to be used in the food and pharmaceutical industries.

According the the FDA requirement on seals and bearings, the material must meet the following standards: 

  • Impervious (sealed so that liquids cannot pass through)
  • Easily cleaned
  • Does not gall or seize
  • Can operate without the help of oil, grease or other lubricants that may contaminate the food

To meet all of the above requirements, food and pharmaceutical companies often turn to impregnated carbon graphite.

MEeting FDA Requirements with Carbon Graphite

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

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.

Materials that have Obtained 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.

Improving Efficiency & ensuring public safety

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.

To speak to an engineer about how carbon graphite can help your operation meet FDA requirements, get in touch today.

Contact a Metcar Materials Engineer