USP Class VI Silicone Sheeting & Continuous Rolls | Healthcare & Medical Grade
Engineered for non-invasive medical devices, healthcare equipment, and pharmaceutical processing, ElastaPro USP Class VI silicone sheeting delivers strict biocompatibility and ultra-low extractable performance. Manufactured in the USA at our AS9100D and ISO 9001:2015 certified facility, our solid silicone sheet rolls, die-cut blanks, and continuous rolls meet rigorous USP Class VI and FDA 21 CFR 177.2600 standards for high-purity healthcare applications.
Biocompatible USP Class VI Silicone for Healthcare & Medical OEM Applications
United States Pharmacopeia (USP) Class VI is the most stringent biological reactivity and toxicity testing classification for medical-grade elastomers. To achieve USP Class VI compliance, ElastaPro silicone compounds undergo comprehensive in vivo testing—including Systemic Injection, Intracutaneous Reactivity, and Muscle Implantation testing—verifying zero adverse biological reactions upon contact with living tissue and fluids.
Specifically formulated with high-purity platinum-cure and peroxide-cure silicone polymers, our healthcare USP Class VI silicone sheeting is ideal for die-cut sanitary gaskets, fluid handling seals, medical diagnostic equipment, and pharmaceutical single-use fluid manifolds.
USP Class VI Silicone Sheet Specifications & Durometer Options
We offer full custom calendering in continuous rolls and cut sheets to match your precise engineering tolerances:
| Parameter | Specification Range | Primary Healthcare / Industrial Use |
|---|---|---|
| Durometer (Hardness) | 30, 40, 50, 60, 70, and 80 Shore A | From soft conformable seals to high-durometer rigid gaskets |
| Thickness Range | 0.010″ to 0.500″ (0.25 mm to 12.7 mm) | Precision thin-gauge diaphragms to thick flange seals |
| Standard Roll Widths | 36″, 48″, and custom master rolls up to 60″ | Continuous roll-to-roll stamping and automated waterjet cutting |
| Temperature Range | -80°F to +450°F (-62°C to +232°C) | Autoclave steam cycles, dry heat sterilization, low-temp storage |
| Standard Colors | Translucent (Natural), White, Red, Black, Custom Shades | High-purity visual inspection and color-coded fluid lines |
Complementary Sanitary & Regulatory Certifications
In addition to meeting USP Class VI requirements, ElastaPro healthcare-grade silicone sheet materials are compounded and certified to meet cross-referenced regulatory standards:
- FDA 21 CFR 177.2600: Complies with U.S. Food and Drug Administration regulations for repeated contact with food, liquid, and pharmaceutical preparations.
- ISO 10993 Compliance: Evaluated for cytotoxicity and biological compatibility in non-invasive healthcare devices.
- 3-A Sanitary Standards: Approved for hygienic fluid transfer in biopharmaceutical and dairy processing.
- Sterilization Compatible: Withstands repeated steam autoclave, Gamma radiation, and Ethylene Oxide (EtO) sterilization protocols without loss of physical durometer or tensile strength.
- RoHS / REACH Compliant: Free from heavy metals, phthalates, animal-derived ingredients (ADI-free), and SVHC chemicals.
Key Healthcare & Medical Device Applications
- Medical Device Gaskets: Precision die-cut seals for diagnostic enclosures, CPAP units, and surgical equipment housing.
- Biopharmaceutical Processing Seals: Sanitary flange gaskets, peristaltic pump diaphragms, and single-use fluid containment seals.
- Laboratory Diagnostics: Microplate seals, fluidic manifold gaskets, and vibration-isolation mounts.
- Food & Beverage Dispensing: Commercial food equipment seals requiring extreme thermal range and non-contaminating properties.
Frequently Asked Questions About USP Class VI Silicone
What is USP Class VI silicone?
USP Class VI silicone is a high-purity silicone elastomer certified under the United States Pharmacopeia biological reactivity testing guidelines. Class VI is the highest and most rigorous designation, requiring the material to show no toxic reaction during systemic injection, intracutaneous tissue reactivity, and intramuscular implantation testing.
Is USP Class VI silicone safe for healthcare and medical devices?
Yes. It’s the industry standard for healthcare equipment, medical device enclosures, biopharmaceutical fluid handling, and non-invasive patient contact components due to its exceptional biocompatibility, low extractables, and resistance to bacterial growth.
Can USP Class VI silicone sheeting be sterilized?
Yes. It retains its mechanical properties and elastomeric seal strength across repeated sterilization procedures—including steam autoclave (121°C/250°F), Gamma irradiation, Ethylene Oxide (EtO) gas, and dry heat exposure.
What is the difference between USP Class VI and FDA 21 CFR 177.2600?
FDA 21 CFR 177.2600 regulates materials suitable for safe contact with food and beverages based on chemical extraction limits. USP Class VI goes beyond food contact by requiring rigorous biological in vivo testing on living tissue to prove complete biological inertness for medical and biopharmaceutical use.
