Medical Grade Silicone Sheets and Rolls
Medical grade silicone from ElastaPro is a high-purity, biocompatible elastomer engineered for mission-critical sealing, gasketing, and fluid management in healthcare and pharmaceutical applications. Manufactured in the USA, our elite line of high-performance medical silicone materials meets the most stringent global regulatory requirements, including USP Class VI, ISO 10993, and FDA 21 CFR 177.2600.
We supply medical grade silicone sheets, continuous roll stock, and uncured compounds to distributors, fabricators, and OEMs worldwide. By providing a clean, stable product platform with exceptional dimensional consistency, ElastaPro ensures your finished gaskets and die-cut components perform reliably in sensitive medical device environments.
The Platinum-Cured Advantage
Why Specify Platinum-Cured Silicone Sheet (Medical Grade)?
At ElastaPro, our high-purity silicone sheet medical grade products are primarily platinum-cured. Unlike traditional peroxide-curing systems, platinum-catalyzed cross-linking delivers significant performance advantages essential for medical-device manufacturing:
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Minimized Extractables: Crucial for applications involving direct contact with skin, blood, or biological fluids.
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No Peroxide By-Products: Eliminates the risk of material “blooming” or chemical residues that could compromise analytical testing or sensitive diagnostics.
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Superior Optical Clarity: Translucent grades offer excellent visibility for monitoring fluid paths in laboratory and pharmaceutical equipment.
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High Tear Strength & Resilience: Maintains mechanical integrity and elasticity throughout demanding medical environments.
Technical Specifications
Capabilities for Medical Grade Silicone Sheets
ElastaPro manufactures healthcare-grade silicone sheet stock to precise durometers and dimensions to support seamless converting, waterjet cutting, and high-speed die-cutting.
| Material Property | Range / Capability | Test Method |
| Durometer (Hardness) | 10 to 70 Shore A | ASTM D2240 |
| Thickness Range | 0.005″ to 0.500″ (0.13 mm to 12.7 mm) | Linear Dimension |
| Standard Widths | 36″ (914 mm) & 48″ (1219 mm) | Manufacturing Spec |
| Custom Roll Widths | Up to 62″ (1575 mm) — Industry Leading Widths | Custom Slitting |
| Operating Temperature | -80°F to +450°F (Intermittent to 500°F) | ASTM D573 |
| Cure System | Platinum-Cured (Peroxide available upon request) | Catalyzed Cure |
| Standard Finishes | Fine Fabric, Smooth Gloss, or Matte | Surface Finish |
| Pricing Indicator | $0.00 (Request for Quote Status) | Custom Manufacturing |
Regulatory Compliance & Biocompatibility
USP Class VI & ISO 10993 Certified Medical Silicone Sheeting
ElastaPro’s raw formulations undergo rigorous independent testing to guarantee total safety and compliance in diagnostic, wearable, and therapeutic medical devices.
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Skin Contact & Wearables: Completely hypoallergenic, non-irritating, and non-reactive, making it ideal for continuous long-term skin exposure.
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Short-Term Implantation: Formulations fully evaluated and certified for medical component contact up to 29 days.
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Pharmaceutical Processing: Fully compliant with Ph. Eur Monograph 3.19 for cleanroom closures, fluid transfer, and sanitary seals.
Advanced Sterilization Compatibility
Whether supplied as pre-cut medical grade silicone sheets or continuous rolls, our elastomers maintain their full tensile strength, elongation, and physical sealing properties after repeated exposure to standard sterilization protocols:
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Autoclave / Steam Sterilization
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Gamma Radiation
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Ethylene Oxide (EtO) Gas
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Electron Beam (E-beam) Processing
Target Applications
Common Medical Silicone Sheet Engineering Uses
Thanks to its physiological inertness and environmental resistance, our medical grade silicone is fabricated into high-reliability components for leading OEMs across the healthcare sector:
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Diagnostic Equipment Enclosures: Low closure force gaskets protecting sensitive internal electronics from liquid and contaminant ingress.
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Wearable Health Monitors: Flexible sensor backings, skin-contact patches, and hypoallergenic device housings.
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Fluid Handling Systems: Precision peristaltic pump seals, valve diaphragms, and pharmaceutical fluid transfer gaskets.
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Lab and Surgical Instruments: High-purity seals for sterilization trays, analytical chemistry tools, and diagnostic test kits.
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Uncured Silicone Compounds: We also supply medical grade uncured compounds engineered for immediate calendering, custom molding, or industrial extrusion.
Frequently Asked Questions (FAQ)
What defines a silicone material as “medical grade”?
To be classified as medical grade silicone, the elastomer must be formulated with high-purity raw ingredients and manufactured under strict quality controls to ensure it is completely biocompatible, non-toxic, and hypoallergenic. ElastaPro’s healthcare-grade materials are thoroughly tested and certified to comply with elite global standards, including USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 regulations.
What is the difference between platinum-cured and peroxide-cured medical silicone sheets?
Platinum-cured medical grade silicone sheets use a platinum catalyst cross-linking method that yields a cleaner finished elastomer with excellent clarity, higher tear strength, and zero volatile peroxide by-products. This minimizes extractables, making it the preferred choice for direct tissue or fluid contact. Peroxide-curing is available and widely used for standard industrial components, but platinum-curing is the gold standard for sensitive medical device and pharmaceutical manufacturing.
Can your medical grade silicone sheeting withstand repeated sterilization?
Yes. High-purity silicone sheet medical configurations are naturally resilient to degradation from extreme heat, moisture, and radiation. Our materials maintain their physical properties, flexibility, and sealing integrity through multiple standard sterilization cycles, including steam autoclaving, Gamma radiation, Ethylene Oxide (EtO) gas, and Electron Beam (E-beam) processing.
What thicknesses and widths are available for ElastaPro medical grade silicone?
We manufacture medical silicone sheeting in standard thicknesses ranging from ultra-thin 0.005″ up to heavy-duty 0.500″. Our standard material widths are 36″ and 48″, but we offer industry-leading custom slitting capabilities up to 62″ wide in continuous rolls. This allows fabricators to optimize their layouts, maximizing yields and minimizing waste during high-speed die-cutting or waterjet processing.
Can medical grade silicone sheets be supplied with an adhesive backing?
Yes. We can supply our medical-grade cellular or solid sheeting materials with high-performance pressure-sensitive adhesives (PSA) or acrylic transfer tapes. If your device requires direct skin contact, we can also configure custom material composites using specialized medical-grade adhesives designed for safe, clean, and hypoallergenic skin contact.
