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FDA grade silicone is a synthetic rubber material that is safe for use in applications involving products intended for human use or consumption. An FDA grade silicone sheet must comply with the Food and Drug Administration’s Title 21 of the Code of Federal Regulations in order to make it safe for humans. Whether commercial, premium, or FDA grade, temperature resistant silicone is highly resistant to extreme temperatures and damaging environmental factors. The main difference between a regular black silicone rubber sheet and an FDA grade silicone sheet are its applications as regular silicone is generally used for industrial applications whereas FDA grade silicone is used in the food industry and medical field.
What is FDA Grade Silicone?
FDA grade silicone is a human-safe rubber material than can be used in applications involving materials intended for human consumption. An FDA grade silicone sheet is often used in the food industry and in the medical field as well as in other applications, such as food sealing and storage. FDA grade silicone sheet must comply with Title 21 of the Code of Federal Regulations. Case in point, “The FDA regulate silicones used in food contact under the auspices of the Center for Food Safety and Nutrition (CFSAN) and for use in pharmaceuticals under the auspices of the Center for Drug Evaluation and Research (CDER)” (Wikipedia.org). An FDA grade silicone sheet is commonly used in the food industrial and in the medical field as it is the ideal human-grade material that is safe to use in applications intended for human consumption. These silicone sheets are offered in the color white due to its aesthetic values. FDA grade white silicone gasket material is often used in food and medical industries as the silicone rubber chemical composition retains safe levels of chemicals in accordance with Title 21 of the Code of Federal Regulations. Aside from aesthetics, FDA grade white silicone gasket material is the ideal material for use in applications that involve extreme high and low temperatures (i.e., food storage and production). Temperature resistant silicone has an operating temperature range of -103 to +500 degrees Fahrenheit making it perfect for use around materials intended for human consumption as it will not burn and release toxic fumes or become brittle and break off. An FDA grade silicone sheet has an operating temperature range of -103 to +500 degrees Fahrenheit. Temperature resistant silicone will remain flexible when exposed to low temperatures as low as -103 degrees Fahrenheit without becoming hard and brittle, making an FDA grade silicone sheet the perfect material for industrial food and medical grade applications.
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(a) What Type of Silicone is Food Safe?
An FDA grade silicone sheet is a food safe type of silicone that will offer a reliable and non-toxic application. FDA grade silicone sheet is the ideal food safe rubber material due to its excellent temperature resistance range. Natural, and even synthetic, rubbers cannot withstand the extreme heat that is often involved in the food industry and medical field. Temperature resistant silicone can withstand temperatures as high as +500 degrees Fahrenheit without melting or becoming deformed. Additionally, silicone will not leach toxic chemicals when it is heated, making it the best food safe rubber material. For instance, “Many experts and authorities consider silicones to be nontoxic and safe for contact with food and drink. For example, Health Canada states: ‘There are no known health hazards associated with use of silicone cookware. Silicone rubber does not react with food or beverages or produce any hazardous fumes’” (mindbodygreen.com). Furthermore, silicone is extremely difficult to ignite; therefore, not only making it a safe choice in material, but also a reliable and long-lasting choice.
(b) What is the Difference Between Food Grade Silicone and Regular Silicone?The difference between food grade silicone and regular silicone can be seen in their composition and ability to be used for human grade applications. An FDA grade silicone sheet must comply with the guidelines set by the FDA in Title 21 of the Code of Federal Regulations. Silicone rubber chemical composition is dependent on the grade of the silicone sheet. A regular, commercial black silicone rubber sheet retains an operating temperature range of -103 to +450 degrees Fahrenheit whereas an FDA grade silicone sheet retains an operating temperature range of -103 to +500 degrees Fahrenheit. Additionally, regular silicone is offered in more colors than food grade silicone. The most common material used in industrial setting is a black silicone rubber sheet due to its dark and sleek industrial aesthetics; however, numerous colorful colors of regular silicone help organize rubber parts to applications to maintain a safe and organized industrial work setting.
(c) What Products are Made of Silicone?
Industrial rubber parts, such as gaskets and seals, and food safe products, such as food storage seals and baking molds, are made of silicone. Temperature resistant silicone is available in three different grades: commercial, premium, and FDA grades. Industrial rubber parts are generally made using commercial and premium silicone rubber sheets; however, an FDA grade silicone sheet is used to make rubber parts for the food industry or medical field. In general, silicone rubbers are highly versatile materials with the ability to resist degradation caused by damaging environmental factors, such as UV rays, ozone, oxygen, and moisture. A commercial grade silicone rubber sheet has an operating temperature range of -103 to +450 degrees Fahrenheit whereas a premium or FDA grade silicone sheet has a higher temperature resistance range of +500 degrees Fahrenheit. Premium grade silicone rubber sheets are often used in applications that are too thermally abrasive for the +450-degree high temperature range of commercial silicone. White silicone gasket material is often food grade silicone rubber as is commonly used to create food safe rubber parts for food and medical applications. A black silicone rubber sheet is generally used to create rubber parts for industrial settings where it may be exposed to extreme high or low temperatures. Silicone rubber sheets are the ideal materials for creating industrial gaskets and seals as its wide operating temperature range allows it to remain functional in harsh temperatures.
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(d) Why is Silicone Expensive?Silicone is expensive because of its long and meticulous manufacturing process. Silicone rubber chemical composition is different compared to natural rubber because it is considered an inorganic polymer. Silicone rubber contains silicon, carbon, hydrogen, and oxygen which combine to form a unique polymer backbone structure. For instance, “Silicone rubber is a durable & highly resistant elastomer (rubber-like material) composed of silicone (polymer) containing silicon together with other molecule like carbon, hydrogen and oxygen. Its structure always comprises siloxane backbone (silicon-oxygen chain) and an organic moiety bound to the silicon” (omnexus.specialchem.com). The silicon atoms derive from silica material and must first be isolated by heating the silica – once this is complete, the silicon is combined with methyl chloride and heated again and then, finally, the material will be cured to form a solid material (Wikipedia.org). An FDA grade silicone sheet will be more expensive than regular silicone sheets due to the extra steps the manufacturers must go through to ensure it is safe. In addition, silicone rubber is also the ultimate thermally stable rubber material available making it even more valued for reliable and safe applications that involves extreme temperatures.
Does Silicone Contain Rubber?
Silicone does not contain rubber, but it does contain silicon, carbon, hydrogen, and oxygen. This combination of elements creates a rubber-like material that is extremely thermally stable and environmentally resistant. Rubber retains an organic carbon-to-carbon polymer backbone structure whereas temperature resistant silicone retains an inorganic silicon-to-carbon polymer backbone. Case in point, because silicone is considered an inorganic polymer it, “comprises a siloxane backbone (silicon-oxygen chain) and an organic moiety bound to the silicon” (omnexus.specialchem.com). This unique silicon-to-oxygen bonded polymer backbone structure gives silicone its superior resistance to extreme high and low temperatures as well as damaging environmental factors such as UV rays, ozone, oxygen, and moisture. Therefore, rubber and silicone are two separate materials and silicone will be much more durable and reliable than rubber.
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(a) How Many Degrees Can Silicone Withstand?
Silicone has a universal low temperature resistance range of -103 degrees Fahrenheit; however, its high temperature resistance range varies from +450 to +500 degrees Fahrenheit depending on grade. Silicone is an extremely thermally stable material that is able to remain functional and durable in applications where it may be exposed to extreme high and low temperatures. A commercial grade or FDA grade silicone sheet can withstand higher temperatures of up to +500 degrees Fahrenheit. On the other hand, a commercial black silicone rubber sheet has a slightly lower high temperature resistance range of +450 degrees Fahrenheit. The higher temperature resistance of FDA grade silicone makes it ideal for use around products intended or human consumption as it will not melt or burn and produce toxic fumes or leach toxic chemicals.
A regular black silicone rubber sheet and an FDA grade silicone sheet both have the same low temperature resistance range of up to -103 degrees Fahrenheit, but they differ in high temperature resistance. An FDA grade silicone sheet can withstand temperatures as high as +500 degrees Fahrenheit which prevent the leaching of toxic chemicals and fumes. In addition, due to its unique silicon-to-oxygen bonded polymer backbone structure, silicone can stand up well against damaging environmental factors, such as UV rays, ozone, oxygen, and moisture. Commercial and premium grade silicone sheets are ideally used in industrial applications that involve extreme high or low temperatures. An FDA grade silicone sheet is ideal for food service and the medical field due to its accordance with the Food and Drug Administration’s Title 21 of the Code of Federal Regulations that make it safe.
What is FDA Grade Silicone?
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