Medical Grade Silicone
Medical grade silicone from ElastaPro is 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.
Medical Silicone Sheeting
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.
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. 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.
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.
Medical Silicone Uncured Compound
In addition to medical grade silicone sheets, ElastaPro offers uncured silicone compound that arrives ready to mold, calendar, or extrude. Our materials are supplied rolled-up off the mill or in sheet form with a poly liner.
Biocompatibility Regulations and Standards for Medical Silicones
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.
FAQs: Medical Grade Silicone
What is medical grade silicone?
Medical grade silicone is a high‑purity elastomer engineered for applications requiring biocompatibility, chemical inertness, low extractables, and resistance to sterilization. ElastaPro supplies formulations suitable for non‑implantable devices, short‑term implantables (less than 29 days), diagnostics, wearables, and pharmaceutical processing.
What makes ElastaPro’s medical silicone different?
ElastaPro manufactures U.S.‑made silicone with tight batch‑to‑batch property control, low‑volatile formulations, and documentation that supports regulatory and quality assurance requirements. Their team consists of silicone industry veterans with decades of experience in high‑purity elastomers.
Which medical certifications and standards are available?
ElastaPro offers materials that meet or support:
- USP Class VI
- FDA‑compliant silicone
- ISO 10993
- European Pharmacopoeia
These platinum-cured silicones are suitable for skin contact, mucosal contact, and short‑term implantation (less than 20 days) depending on the formulation.
What sterilization methods can ElastaPro medical silicone withstand?
ElastaPro’s medical silicones are compatible with:
- Autoclave
- Gamma radiation
- E‑beam
- Ethylene oxide (EtO)
This makes them suitable for reusable devices, pharmaceutical processing, and clinical environments.
What forms does ElastaPro supply—sheet or uncured compound?
ElastaPro provides both:
- Medical silicone sheet (0.005″ to 0.500″ thick, widths up to 62″, custom colors, PSA backing optional)
- Uncured medical silicone compound for molding, extrusion, or custom fabrication, available in peroxide‑cured or platinum‑cured systems.
What applications use medical grade silicone sheet?
Medical silicone sheet is commonly used for:
- Gaskets and seals
- Diagnostic equipment
- Wearable medical devices
- Pharmaceutical processing
- Fluid handling systems
- Lab and analytical instruments
Its consistency and purity make it ideal for precision components.
What are the advantages of platinum‑cured silicone?
Platinum cured silicone offers extremely low extractables, high purity, excellent clarity, and consistent mechanical properties. It is preferred for sensitive medical, diagnostic, and pharmaceutical applications where contamination control is critical.
Can ElastaPro provide custom colors or formulations?
Yes. ElastaPro offers custom colors, custom cure systems, and tailored formulations to meet specific device, processing, or regulatory requirements.
Is medical grade silicone suitable for wearable devices?
Yes. Medical grade silicone is hypoallergenic, non‑reactive, flexible, and stable under repeated flexing—making it ideal for skin‑contact wearables, patches, and sensor housings.
Does ElastaPro support short‑term implantable applications?
Certain ElastaPro formulations are suitable for short‑term implantable components (less than 29 days), depending on the grade and regulatory requirements. Engineers should review the specific certification data for ElastaPro’s USP Class VI and ISO 10993 testing.
What mechanical and thermal properties can engineers expect?
ElastaPro medical silicones maintain performance across extreme temperatures, repeated flexing, and long‑term environmental exposure. They are chemically inert, non‑toxic, and stable under sterilization cycles.
Why do medical device engineers choose ElastaPro?
Engineers rely on ElastaPro for:
- U.S. manufacturing and fast lead times
- Consistent batch‑to‑batch quality
- Technical support from silicone experts
- Custom formulations and colors
- Competitive pricing and responsive service
This combination helps teams move from concept to production with confidence.
For more information, contact ElastaPro.
