Medical Grade Silicone
Medical grade silicones from ElastaPro are used for sealing and gasketing in medical devices and equipment. These platinum-cured materials meet FDA Title 21 CFR 177.2600, USP Class VI, ISO 10993, and European Pharmacopoeia requirements. ElastaPro manufactures medical silicones in the United States and supplies them as solid sheets, continuous rolls, and uncured compounds.
Although ElastaPro doesn’t supply major medical OEMs directly, our materials are known and trusted by leading manufacturers of medical devices and equipment. The fabricators that we partner with have presented us as their supplier of medical grade silicones, and ElastaPro has passed audits by major medical OEMs with names that you’d recognize.
Keep reading to learn more and contact ElastaPro for a quote.
What are Medical Grade Silicones?
Medical grade silicones are formulated for a higher degree of purity than general purpose grade silicones. That’s because medical silicones directly contact – and must not have a negative effect upon – human skin, blood and fluids, or living tissue. The medical elastomers that ElastaPro makes aren’t designed for long-term implantation, but they’re free from substances that could cause harmful biological reactions during short-term use (<29 days in the body).
ElastaPro’s medical grade silicones are biocompatible, hypoallergenic, and do not have an unpleasant smell or odor. They also resist cleaning chemicals, bodily fluids, and bacterial growth. These medical elastomers are safe for steam and gamma sterilization, do not contain organic plasticizers, and are phthalate and peroxide free. Importantly, they comply with FDA Title 21 CFR 177.2600, USP Class VI, ISO 10993, and European Pharmacopeia monograph 3.19.
Specifications Grade Materials and Certificates of Analysis
Medical grade silicones from ElastaPro are specifications grade materials that meet the following regulations and standards.
- FDA Title 21 CFR 177.2600 is a regulation that establishes low levels of extractables, substances that can leach from a material. Although this U.S. regulation does not explicitly govern medical devices, it’s a preferred starting point among medical manufacturers.
- USP Class VI is a biocompatibility standard from the United States Pharmacopeia (USP), a non-profit organization. The FDA recognizes and uses this standard, which establishes testing protocols and complements the FDA’s own 21 CFR 177.2600.
- ISO 10993 is an international standard for evaluating the biocompatibility of medical grade silicones. It contains more extensive testing requirements than USP Class VI and ensures that medical devices don’t cause adverse biological reactions in the people who use them.
- European Pharmacopoeia standards ensure that a material is safe for pharmaceutical use. It includes requirements for both biocompatibility and chemical properties. Ph. Eur monograph 3.19 applies to silicone elastomers for closures (containers) and tubing.
ElastaPro’s medical grade silicones meet all these requirements, and we offer a full Certificate of Analysis (COA) with every batch. Unlike a Certificate of Conformance (COC), a COA does not simply attest that a material meets requirements. Instead, a COA contains batch-level test data. Medical grade silicones from ElastaPro are typically translucent, but buyers can request materials that are white, red, blue, green, gray, or available in custom silicone colors.
Medical Grade Silicone Sheets and Continuous Rolls
ElastaPro calendars medical grade silicones into solid elastomers that can be die cut into parts for peristaltic pumps, insulin pumps, and other types of medical devices and equipment. This process creates flexible, durable silicone sheets that can be precisely controlled for thickness, texture, and other properties.
Medical grade solid silicone sheet are available in:
- Durometers: 10 to 70 Shore A
- Thicknesses: .007” to .500”
- Widths: Up to 60”
- Colors: While typically translucent, various colors are availabe
These products are Made to Order and supplied in a gloss or matte finish. ElastaPro can also supply you with silicone rolls that we can slit-to-width for automated cutting operations.
Medical Grade Silicone for Molding
In addition to medical grade silicone sheets, ElastaPro offers uncured silicone compound that arrives ready-to-mold. Our materials are supplied rolled-up off the mill or in sheet form with a poly liner. Whether you need medical grade silicone sheets, continuous rolls, or medical grade silicone for molding, we’d welcome your inquiry.
