Medical Grade Silicone   VS   Food  Grade Silicone

Both medical grade and food grade silicones are safe to touch the human body and won’t hurt or irritate it. They are both used for sensitive things, but there are small changes that will affect how they are approved for use on people. Silicone product manufacturers say they both have their specific uses.

When making something for sensitive use, silicone is the best material. Because it’s made in a way that makes it immune to heat, mold, and even UV light. This makes it tasteless, safe, and odorless as well. Because of these great qualities, liquid silicone rubber lasts longer than other kinds of rubber. The material is very strong when pulled apart, and it can handle temperatures from -100 °C to 200 °C. Silicone, food grade Silicone rubber is great for all kinds of goods, even those that need to be food-grade or medical-grade. It is very easy to compress. Food-grade and medical-grade silicone both come into direct and indirect touch with the body, so it shouldn’t irritate or hurt the body when it does. Now that you know why silicone rubber is the best, let’s talk about what makes food-grade silicone rubber different from medical-grade silicone rubber.

An example of a Medical Grade Silicone. (Silicone breast implants).

What is a Food Grade Silicone Rubber?

Food-grade silicone rubber is made of a material that meets the rules for food safety in a certain country or area. If it passes the tests, it could mean that the material is safe for use in food, like in silicone dishes.

An example of food grade silicone rubber, which is the pink browning baking sheet.

How to Get a Food Grain Approval

The regulating body will have to check the silicone rubber to see if it is safe for food. Finding out who makes the rules for food safety is important. For sure, the medical-grade silicone products will then follow the rules set by the governing body. In the end, each country or area has its own rules about food.

How do the Regulating Bodies Check Silicone Rubber

To do this, they will perform tests, scans, and fingerprinting of the silicone. They will search the custom silicone rubber materials for any signs of potentially toxic substances like formaldehyde. A particular platinum-catalyzed curing procedure must be used to create silicone rubber that is safe for use in culinary applications. In order to guarantee that the food-grade silicone’s mechanical qualities will function properly, it should additionally undergo a post-curing procedure. Any volatile byproducts from the silicone will also be eliminated by this procedure. Crosslinking between chemicals and any low-molecular raw material components may cause this.

Difference Between Food Grade and Medical Grade Silicone

One form of silicone that is safe to use with food is called food-grade silicone. A common material used to create moulds for food that starts off liquid and solidifies is silicone. It is safe to use on a variety of plastic goods, nontoxic, and does not leave stains on food, dishes, or cookware. It can also be removed off cast objects with ease.

Unlike any other elastomer in the world, silicone rubber has been used extensively as a food-grade material in several applications due to its outstanding purity, odorlessness, non-toxicity, non-corrosiveness, and inert qualities. Generally speaking, any silicon goods that come into contact with food must adhere to any food standards that have been established by various nations or areas.

Furthermore, post-curing is advised for items that come into contact with food in order to enhance their mechanical qualities and—above all—get rid of the volatile byproducts that are produced when low-molecular components and cross-linking agents are used. Food-grade silicone finds use in ice cube trays, baking moulds, handles for knives, whisks, spoons, and other kitchen tools, as well as seals and o-rings that come into contact with food.

Because of their non-toxic and inert properties, medical grade silicone rubbers are the most often used synthetic rubber among all synthetic elastomers in subdermal devices that are permanently implanted. While specific vulcanizing agents and fillers are employed in the production of silicone rubber, the rubbers lack a broad range of additives that are utilized as compounding ingredients in the production of organic rubber.

Medical-grade silicones come in two varieties: those that vulcanize at ambient temperature and those that vulcanize under heat.

Three requirements must be met for silicones to be deemed “medical grade”;

  • Excellent pharmaceutical manufacturing conditions,
  • a lengthy history of successful implantation in humans and animals,
  • and quality control for medical use.

The use of platinum-catalyzed curing systems is advised for custom silicone rubber products intended for medical use. Because peroxide curing leaves or blooms acid leftovers after the curing process, it is not advised. Feeding tubes, catheters, long- and short-term implants, gaskets and sealants, syringe pistons, scar therapy silicone sheets, gels, condoms, menstruation cups, respiratory masks, and other items are made of medical-grade silicone.

Manufacturing Procedure of Food Grade Silicone

Since food-grade silicone is typically manufactured from imported raw materials, whose quality is predetermined, the pertinent quality inspection report is essential when procuring raw materials. This is not to suggest that regular silicone is of lower quality; rather, it is to suggest that the two have distinct uses. Food-grade fumed rubber is used to create items with better quality standards than ordinary silicone rubber, which is mixed to create ordinary custom silicone rubber products. We are aware that one of the primary ingredients in silica gel is silica, and since fumed silica has a higher purity density than regular silica, there will be some variation in the final product, mostly in the tensile strength. There won’t be any bleaching while stretching because food-grade silicone has a strengthening impact on the tensile qualities. Consequently, this is where you determine whether or not the custom silicone product is fit for food use.

What is Medical Grade Silicone?

When silicone is reduced to its most basic components, it is composed of silicon dioxide, which is silicon and oxygen plus maybe additional hydrogen and oxygen atoms. We now also understand the origin of silicone’s name, as silicone dioxide makes up a significant portion of it. A mineral called silicon dioxide can be found in concrete, granite, rock, and sand on Earth. In fact, it comprises more than a quarter of the crust of our planet, making it the most prevalent material on Earth. It has been used for ages to produce glass, among other things. In more recent times, it has also been used in more sophisticated ways, including the 1930s invention of silicone.

Conclusion

For a variety of sectors, different custom silicone product grades offer unique qualities and uses. Food-grade silicone is appropriate for applications where it comes into contact with food and complies with strict safety regulations, whereas industrial grade silicone is more flexible and less expensive for non-medical and non-food applications. Medical grade silicone is ideal for a range of implants and medical equipment since it is extremely biocompatible. HCR silicone is appropriate for extrusions and molded parts because of its consistency and durability.

Conversely, LSR silicone is extremely accurate and capable of filling complex molds, but it has limitations in some situations. It’s critical for producers and consumers to comprehend the distinctions between silicone grades in order to choose products wisely for their intended applications. It’s also essential to collaborate with trustworthy silicone manufacturers or silicone product manufacturers to guarantee the product’s dependability and quality. The future of silicone products is in extending their applications, cutting costs, and enhancing biocompatibility. To develop fresh, cutting-edge silicone goods that can meet the expanding needs of many industries, ongoing research and development is required.

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