Medical Grade Silicone Sheets and Rolls
High-Performance 30 to 70 Durometer Medical Grade Silicones
ElastaPro offers solid medical silicone sheets across a full range of Shore A durometers to match your specific compression set, tear resistance, and sealing requirements:
- ESS30HC – 30-Durometer Medical Grade Silicone Sheet
- ESS40HC – 40-Durometer Medical Grade Silicone Sheet
- ESS50HC – 50-Durometer Medical Grade Silicone Sheet
- ESS55HC – 55-Durometer Medical Grade Silicone Sheet
- ESS60HC – 60-Durometer Medical Grade Silicone Sheet
- ESS65HC – 65-Durometer Medical Grade Silicone Sheet
- ESS70HC – 70-Durometer Medical Grade Silicone Sheet
Why Specify Platinum-Cured Medical Silicone Sheeting?
At ElastaPro, our high-purity medical silicone sheeting products are primarily catalyzed using advanced platinum-curing technology. Unlike standard peroxide-cured materials, specifying a platinum-cured medical grade silicone sheet provides critical performance advantages required for sensitive medical device manufacturing and fluid contact:
- Minimized Extractables & Leachable Compounds: Essential for devices involving direct contact with skin, blood, or biological fluids.
- No Peroxide By-Products: Eliminates material blooming and chemical residue that could compromise analytical testing or sensitive diagnostics.
- Superior Optical Clarity: Translucent medical grade silicone sheets provide visual clarity for monitoring fluid paths in lab, diagnostic, and pharmaceutical equipment.
- High Tear Strength & Resilience: Maintains structural integrity, flexibility, and sealing force under severe dynamic stress.
Technical Specifications & Manufacturing Capabilities
ElastaPro manufactures medical grade silicone sheets and rolls to precise durometers, custom thicknesses, and industry-leading roll widths to optimize yield during waterjet cutting, flash cutting, and high-speed rotary die-cutting.
| Material Property | Range / Capability | Test Method |
|---|---|---|
| Material Classification | Platinum-Cured Medical Grade Silicone Sheeting | USP Class VI / ISO 10993 |
| Durometer (Hardness) | 30 to 70 Shore A | ASTM D2240 |
| Thickness Range | 0.005″ to 0.500″ (0.13 mm to 12.7 mm) | Linear Dimension |
| Standard Roll Widths | 36″ (914 mm) & 48″ (1219 mm) | Standard Production |
| Custom Sheeting Widths | Up to 62″ (1575 mm) continuous roll stock | Custom Slitting & Calendering |
| Operating Temperature | -80°F to +450°F (-62°C to +232°C) | ASTM D573 |
| Primary Cure System | Platinum-Cured (Peroxide available upon request) | Catalyzed Cross-Linking |
| Standard Finishes | Fine Fabric, Smooth Gloss, or Matte | Surface Finish |
Regulatory Compliance & Biocompatibility
USP Class VI & ISO 10993 Certified Medical Silicone Sheet Products
Every lot of raw silicone used in our medical grade silicone sheets undergoes rigorous independent testing to guarantee compliance across medical, diagnostic, wearable, and therapeutic applications:
- Skin-Contact Devices & Wearables: Hypoallergenic, non-irritating, and non-reactive medical silicone sheeting designed for long-term skin exposure and continuous wear.
- Short-Term Implantation (Up to 29 Days): Formulations thoroughly evaluated and certified for medical component contact up to 29 days.
- Pharmaceutical & Cleanroom Processing: Compliant with Ph. Eur Monograph 3.19 for cleanroom closures, fluid delivery systems, and sanitary processing gaskets.
Advanced Sterilization Compatibility
Whether converted into die-cut parts from single medical silicone sheets or processed from continuous roll stock, ElastaPro materials retain physical properties, dimensional stability, and sealing integrity after repeated sterilization cycles:
- Autoclave / Steam Sterilization
- Gamma Radiation
- Ethylene Oxide (EtO) Gas
- Electron Beam (E-Beam) Processing
Common Engineering Applications for Medical Silicone Sheets
Because of its biological inertness, low compression set, and thermal stability, our medical grade silicone sheeting is trusted by leading healthcare OEMs and die-cutters for:
- Diagnostic Equipment Enclosures: Low closure-force environmental seals protecting internal sensors and microelectronics from liquid ingress.
- Wearable Health Monitors: Flexible sensor backings, skin-contact patches, and hypoallergenic device housings.
- Fluid Management & Diagnostics: Precision peristaltic pump seals, valve diaphragms, and pharmaceutical fluid transfer gaskets.
- Surgical & Laboratory Instruments: High-purity seals for sterilization trays, analytical instruments, and diagnostic test cartridges.
- Custom Compounding & Calendering: We also supply medical-grade uncured compounds engineered for immediate calendering, custom molding, or precision extrusion.
Frequently Asked Questions (FAQ)
What defines a material as a medical grade silicone sheet?
To qualify as a medical grade silicone sheet, the elastomeric compound must be formulated with ultra-pure raw ingredients and manufactured under strict quality controls to ensure it is biocompatible, non-toxic, and non-cytotoxic. ElastaPro’s medical grade silicone sheets are thoroughly tested to exceed USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 standards.
What is the difference between platinum-cured and peroxide-cured medical silicone sheeting?
Platinum-cured medical silicone sheeting utilizes a platinum-catalyzed cross-linking process that produces a clean finished elastomer with higher tear strength, exceptional clarity, and zero volatile peroxide residue. This prevents blooming and extractables, making platinum-cured medical silicone sheets the preferred standard for fluid transfer, medical devices, and analytical equipment.
Can ElastaPro supply medical grade silicone sheets with custom widths and thicknesses?
Yes. We manufacture medical grade silicone sheets and continuous sheeting in standard thicknesses from ultra-thin 0.005″ up to 0.500″. While standard roll widths are 36″ and 48″, ElastaPro offers custom slitting and calendering up to 62″ wide. This extra width maximizes nested yield and reduces waste for converters using high-speed die-cutting or waterjet equipment.
How well does a medical silicone sheet perform under repeated sterilization?
An ElastaPro medical silicone sheet exhibits extreme thermal and environmental stability. The elastomer retains its mechanical strength, elasticity, and sealing properties through multiple standard sterilization cycles, including steam autoclaving, Gamma radiation, Ethylene Oxide (EtO) gas, and E-beam processing.
Can medical grade silicone sheets be backed with pressure-sensitive adhesives (PSA)?
Yes. Our solid medical silicone sheets and continuous sheeting can be laminated with high-performance pressure-sensitive adhesives (PSA) or acrylic transfer tapes. For direct skin-contact applications, we recommend specialized medical-grade adhesive composites designed for hypoallergenic skin adhesion and clean removal.
