Manufacturing FDA compliant custom moulded rubber

Sep 16
17:18

2021

Aimee Harrington

Aimee Harrington

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The United States Food and Drug Administration (FDA) imposes strict standards on the manufacture of food, drugs and cosmetics. The FDA’s influence goes well beyond the United States, prompting custom rubber manufacturers to use FDA approved rubber to produce components for the food and beverage, medical and pharmaceutical industries. Rubber manufacturer, TRP Polymer Solutions, explains the manufacturing process behind FDA compliant custom moulded rubber products.

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What is FDA approved rubber?

The US-based Food and Drug Administration (FDA) is responsible for protecting the public health of American citizens by regulating a wide range of products,Manufacturing FDA compliant custom moulded rubber Articles including foods, human and veterinary drugs, vaccines and other biological products, medical devices for human use, radiation-emitting electronic products, cosmetics, dietary supplements, and tobacco products. FDA standards have become the de facto benchmark globally for all food grade rubber.

All FDA approved rubber products are handled and packaged in a certified cleanroom environment. They are also subjected to rigorous testing to meet the demands of even the most challenging hygienic applications. FDA approved rubber should be tasteless, odourless and resistant to bacteria. It should also provide reliable service across a wide range of operational temperatures. FDA rubber must also be non-toxic and non-allergenic.

FDA approved rubber materials

The following FDA approved rubber materials are among the most commonly used in hygienic applications due to their exemplary characteristics.   

EPDM 

EPDM is employed in applications requiring durability and flexibility. Manufactured from tasteless and odourless compounds, EPDM is suitable for speciality or general purpose food and beverage applications. It has an operating temperature of -50°C to +150°C and performs well with hot water and steam.

FFKM (Perfluoroelastomers)

FFKM’s extreme chemical and temperature resistance has seen it employed in high pressure clean in place (CIP) cleaning and sterilisation processes in the food, beverage and dairy industries. This food grade rubber material has an operational temperature range of -15°C to +300°C and best in class chemical resistance.

Neoprene 

Neoprene’s smooth finish, excellent resistance to abrasion and repulsion of oily and greasy food products make it an ideal food grade rubber material. Resistant to ozone, sunlight and oxygen ageing, neoprene is the material of choice for refrigeration seals. Neoprene is also highly resistant to water and the build-up of mould.

Silicone 

Silicone has long been highly regarded in the food and beverage industry for its thermal stability, heat resistance, low chemical reactivity and low toxicity. This long-life food grade rubber has one of the widest operating temperature ranges available, from -50°C to +200°C. Common uses include sealants and cooking utensils.

High-performance FDA rubber components

TRP Polymer Solutions designs and manufactures high-performance rubber moulded components, including food grade ‘O’ rings and gaskets, made from FDA approved rubber materials. We only use the best materials and process technologies when manufacturing FDA rubber, including the aforementioned high-grade materials.

Those are just a few of the FDA approved rubber materials that we use to develop optimised food grade gaskets and ‘O’ rings at TRP Polymer Solutions. For any more information about our FDA approved rubber materials and product capabilities, or to discuss your specific application in more detail, our experts are only too happy to help.

For more information, please visit www.trp.co.uk