Medical silicone sheeting plays a critical role in healthcare applications that require performance, stability, and biocompatibility under demanding conditions. Unlike general purpose grade silicone, medical grade silicone is engineered to meet stringent regulatory, mechanical, and environmental requirements. That’s what makes medical silicones safe for contact with human skin, blood and fluids, or living tissue. It’s also why these biocompatible materials can withstand repeated sterilization cycles.
Medical Silicone Sheeting: Durometers, Widths, and Thicknesses
ElastaPro produces medical silicone sheeting in controlled formulations and to durometers, widths, and thicknesses that medical OEMs need. At our Made in USA manufacturing facility, we calendar medical grade silicones into solid sheets that arrive ready for die cutting or other fabrication methods. These materials are easy to cut or convert and provide a superior gasket and sealing solution.
- Durometers range from 10 to 70 Shore A.
- Widths up to 60” wide are available
- Thicknesses range from .007” to .500”
ElastaPro’s medical silicone sheeting is typically translucent, but various colors (including custom color matching) are achievable. We can also supply silicone rolls that are slit-to-width for automated cutting operations. No matter what you order, you’ll receive medical silicones that are free from unpleasant smells and odors, organic plasticizers, and phthalates.
Platinum Curing vs. Peroxide Curing
ElastaPro’s medical silicone sheeting is platinum-cured instead of peroxide-cured to minimize extractables and leachables, eliminate peroxide by-products, and provide the stability that FDA Title 21 CFR 177.2600 requires. Platinum-cured silicones also exhibit low volatility and consistent mechanical behavior across a wide temperature range. In addition, they have excellent clarity in translucent grades. ElastaPro can provide peroxide-cured materials for healthcare applications, but post-curing is required.
Biocompatibility and Compliance
Biocompatibility is a key characteristic of ElastaPro’s medical silicone sheeting. In addition to FDA Title 21 CFR 177.2600 requirements, these materials are engineered to comply with USP Class VI, ISO 10993, and Ph. Eur Monograph 3.19 from the European Pharmacopoeia. As our Healthcare Grade Silicone Sheeting Certification shows, USP Class VI and ISO 10993 studies were performed for test items ranging from 10 to 70 durometer (Shore A) and showed no relevant biological effects.
- USP Class VI studies include acute system toxicity, intracutaneous toxicity, and short-term implantation (less than 29 days).
- ISO 10993 studies include cytotoxicity, hemolysis, pyrogenicity, sensitization, dermal irritation, and implantation (90 days).
Mechanical Performance
Mechanical performance is another key characteristic of ElastaPro’s medical silicone sheeting. These materials maintain their elasticity, tear strength, and tensile properties even after repeated sterilization by autoclave, gamma, or ethylene oxide (EtO) methods. They also retain their modulus and compression set characteristics for reliable sealing and cushioning in medical devices that undergo repeated use.
In sealing and fluid management applications, silicone’s low compression set and resistance to swelling are essential. Parts cut from medical silicone sheets can form reliable seals under low pressure for use in lightweight housings and compact devices. Because silicone is inherently inert and hydrophobic, it resists swelling in aqueous environments and maintains dimensional stability when exposed to biological fluids, such as in diagnostic and therapeutic systems.
Thermal Stability and Environmental Resistance
ElastaPro’s medical silicone sheeting also provides excellent thermal and environmental resistance. These materials remain functional from approximately −80°F to +450°F, supporting their use in sterilization chambers, heated fluid paths, and outdoor or transport‑exposed medical equipment. At intermittent temperatures, ElastaPro’s medical silicone sheets resist heat up to 500°F. Medical silicone sheets also resist UV, ozone, and oxidation for long‑term reliability in portable devices and emergency equipment.
Choose High-Quality Medical Silicone Sheeting
ElastaPro makes medical silicone sheeting from high-quality raw materials and provides a Certificate of Analysis (COA) with every batch. Our precision calendaring ensures uniform thickness and a consistent surface finish, attributes that support efficient cutting and conversion processes. To request a quote or discuss your healthcare application, contact ElastaPro.
