Medical Grade Silicone Sheeting & Uncured Compounds
Compliant Medical Silicone Sheeting
ElastaPro’s medical grade silicone sheets are fully compliant with the following specifications:
These high-purity, platinum-cured materials are engineered for biocompatible medical devices, healthcare equipment, and pharmaceutical processing.
Every batch is Made in USA under ElastaPro’s ISO 9001:2015 / AS9100D quality system and shipped with a complete Certificate of Analysis (COA).
Need Medical Grade Silicone Sheet or Slit Rolls?
We supply continuous rolls, pre-cut sheets, and uncured compounds with low minimums and fast lead times.
Request a Quote (RFQ)Medical Grade Silicone Sheets (10 to 70 Durometer)
Choose medical grade silicone sheet in these durometers (Shore A).
This is a made-to-order product available in a gloss or matte finish.
Sizes & Specifications for Medical Silicone Sheeting
Medical silicones from ElastaPro feature low extractables, superior tear strength, and continuous thermal stability. They maintain their physical properties and sealing integrity across repeated sterilization cycles, including autoclave, gamma radiation, and EtO methods.
| Material Property / Feature | Specification Details | Standard / Test Method |
|---|---|---|
| Durometer Range | Shore A 30 to 70 (30, 40, 50, 55, 60, 65, 70) | ASTM D2240 |
| Nominal Thickness | 0.005″ to 0.500″ (0.127 mm to 12.70 mm) | ASTM D3767 |
| Thickness Tolerance | ±0.005″ (Standard Precision Calendering) | N/A |
| Standard Roll Widths | 36″ (914 mm) and 48″ (1219 mm) | N/A |
| Custom Roll Widths | Slit to order; custom calendering up to 62″ (1.57 m) | N/A |
| Tensile Strength | 1,000 to 1,500 psi (6.9 to 10.3 MPa) (Grade Dependent) | ASTM D412 |
| Elongation % | 300% to 750% (Varies by Shore A hardness) | ASTM D412 |
| Tear Strength | 100 to 250 ppi (17.5 to 43.8 kN/m) (Die B / Die C) | ASTM D624 |
| Temperature Range | -80°F to +450°F (-62°C to +232°C) | Continuous Operation |
| Cure System | High-Purity Platinum Catalyzed (Addition Cure) | Zero peroxide residue |
| Regulatory Standards | USP Class VI, ISO 10993, FDA 21 CFR 177.2600, Ph. Eur Monograph 3.19 | Fully Certified Lot-to-Lot |
| Sterilization Compatibility | Autoclave / Steam, Gamma Radiation, EtO Gas, E-Beam | Retains tensile & sealing integrity |
Medical Silicone Sheeting FAQs
What is medical grade silicone?
Medical manufacturing demands materials that are safe, stable, and capable of performing reliably in environments where human health is at stake. That’s why so many engineers and OEMs ask the same foundational question: what is medical grade silicone?
At its core, medical grade silicone is a highly purified, biocompatible elastomer engineered to meet strict standards for use in medical devices, pharmaceutical processing, and healthcare equipment.
Its unique combination of cleanliness, flexibility, and chemical stability makes it one of the most trusted materials in modern medical design.
What makes a silicone medical grade?
It helps to look at the characteristics that set it apart from general‑purpose silicone. Medical grade silicone is formulated, processed, and tested to ensure it can safely contact skin, tissue, bodily fluids, and sensitive pharmaceutical media. This includes:
- Biocompatibility testing to confirm the material does not cause irritation, toxicity, or adverse biological reactions.
- High‑purity formulations with tightly controlled additives and cure systems.
- Consistency and traceability across batches to support regulatory compliance.
- Compatibility with sterilization methods such as autoclave, gamma radiation, and ethylene oxide.
These attributes make medical grade silicone suitable for components that must perform flawlessly in critical environments.
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.
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.
What standards apply to medical grade silicone sheet materials?
A key part of defining what is medical grade silicone involves the standards it meets. While requirements vary by application, medical grade silicone often aligns with:
- USP Class VI biocompatibility testing
- ISO 10993 medical device biological evaluation
- FDA compliance for food and drug contact
- Pharmaceutical purity expectations for processing environments
These standards help ensure that silicone components perform safely and predictably in regulated industries..
How does ElastaPro ensure USP Class VI and ISO 10993 compliance?
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.
What are some applications for die cut medical silicone parts?
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.
Does medical silicone sheeting withstand repeated sterilization?
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
What are some healthcare and life science applications?
Its stability, softness, and resistance to chemicals and temperature extremes make it ideal for:
- Seals and gaskets in medical devices
- Pharmaceutical and biotech processing equipment
- Tubing, valves, and fluid‑handling components
- Wearable medical products and patient‑contact interfaces
- Single‑use systems and high‑purity assemblies
Because it maintains its properties under stress, sterilization, and repeated use, it supports both disposable and long‑term medical products.
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
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.