Elasto Proxy fabricates and distributes FDA approved silicones that meet rigorous safety standards from the U.S. Food and Drug Administration (FDA). These silicone elastomers are specially formulated to ensure that harmful substances will not leach out or cause contamination when there is direct contact with food items. FDA approved silicones are also used in medical and pharmaceutical applications.
Food processors and packagers, medical manufacturers, and pharmaceutical companies who need FDA approved silicones can source sponge profiles or solid profiles from Elasto Proxy. We also supply molded parts and finished gaskets that arrive ready-to-install. As a value-added manufacturer, we can source the elastomers you need, store them in our warehouses, and fabricate them on-demand or in response to your sales forecasts.
Keep reading to learn more and contact us for a quote. Elasto Proxy works with a trusted network of materials suppliers, and we offer low-to-medium volumes that can be challenging to source.
What are FDA Approved Silicones?
FDA approved silicones comply with CFR 21, Part 177.2600, a regulation that specifies requirements for rubber articles intended for repeated use in contact with food. This part of the U.S. code of federal regulations (CFR) is relevant for medical products, particularly those that involve direct contact with the human body or bodily fluids.
What is CFR 21, Part 177.2600?
FDA CFR 21, Part 177.2600 sets limits on substances, such as additives, that can migrate from rubber into food. It also establishes test requirements for assessing the safety of rubber materials. CFR 21 177.2600 is not a biocompatibility standard, but it does provide a foundation for material selection in the medical and pharmaceutical industries. Both industries also have their own safety standards.
Key Properties of FDA Approved Silicones
Silicones withstand higher temperatures than other elastomers, but high heat can cause substances like additives to migrate and cause contamination. FDA approved silicones are formulated to minimize this migration, which is also known as leaching. Like other types of silicones, FDA approved silicone elastomers are chemical and moisture resistant, flexible, and elastic.
FDA Approved Silicones vs. FDA Compliant Silicones
FDA approved silicones and FDA compliant silicones are similar, but they’re not the same.
- FDA approved silicones have been thoroughly tested to FDA standards by an FDA agent or expert. These materials have been proven safe for their intended use.
- FDA compliant silicones meet FDA standards but have not been tested by an FDA agent or expert. Often, the testing they receive is not as thorough as with FDA approved materials.
Sometimes, FDA compliant silicones are called FDA certified instead. Regardless, FDA certification is not an official FDA term. The phrase “food grade silicone” is also used, but it’s an unofficial way of calling a silicone product FDA complaint.
FDA Approved Solid Silicone
FDA approved solid silicone is extruded into specific cross-sectional shapes (profiles) or molded into sheets. Elasto Proxy distributes materials in both form factors, and we also fabricate finished gaskets for applications such as food and medical equipment. Compared to sponge rubber, solid rubber provides greater impact resistance. Examples include solid silicone bulb trim for edge protection.
FDA Approved Silicone Sponge
FDA approved silicone sponge is also extruded into profiles or molded into sheets. It’s available for distribution or fabrication and can have open cells or closed cells. Compared to solid rubber, sponge rubber is generally softer and provides greater cushioning. Applications include fluid sealing, gasket strips, and pads.
Molded Silicone Parts and Finished Gaskets
Elasto Proxy can also supply you with molded rubber parts (such as tubing) made from FDA approved silicones. Unlike some other suppliers, we can meet demand for small runs as well as high volumes. With our water jet cutting equipment, we can also provide you with cost-effective quantities of finished gaskets in low-to-medium volumes.
Choose FDA Approved Silicones from Elasto Proxy
Elasto Proxy distributes and fabricates the FDA approved silicones that manufacturers in the food, medical, and pharmaceutical industries need. If you’re ready to discuss your application, talk to our team. We are ISO 9001:2015 certified and have facilities in Canada, the United States, and Europe.
