USP Class VI Silicone Sheeting & Uncured Compounds | Healthcare & Medical Grade

Platinum Cured for Cleanliness and Purity

ElastaPro USP Class VI silicone sheeting and uncured compound is ideal for non-invasive medical devices, healthcare equipment, and pharmaceutical processing. It’s platinum cured for ultra-low levels of extractables, substances that can migrate until elevated temperatures or pressures.

These medial grade silicones are Made in the USA in accordance with our AS9100D and ISO 9001:2015 certified facility. Our USP Class VI silicones also meet ISO 10993, Ph. Eur. 3.1.9, and FDA 21 CFR 177.2600 requirements. Applications include pharmaceutical manufacturing and food processing.

👉 Read What the End of USP Class VI Means for Medical Manufacturers?

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USP Class VI Silicone Specifications

ElastaPro offers full custom calendering in continuous rolls and cut sheets to match 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	0.005″ to 0.675″ (0.13 mm to 17.145 mm)	Precision thin-gauge diaphragms to thick flange seals
Standard Roll Widths	36″, 48″, and custom master rolls up to 67″	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

Biocompatible Materials for Medical & Healthcare

In industries where patient safety, biocompatibility, and contamination control are non‑negotiable, USP Class VI requirements serve as one of the most trusted benchmarks for material qualification.

Medical device manufacturers, pharmaceutical processors, and biotech equipment builders rely on this standard to ensure that elastomers, plastics, and rubber components can safely contact drugs, biological media, and sensitive fluids without leaching harmful substances.

For companies sourcing high‑performance rubber components, understanding these requirements is essential for selecting materials that meet regulatory expectations and withstand demanding sterilization and processing environments.

What USP Class VI Requirements Test

USP Class VI Requirements come from the United States Pharmacopoeia (USP) and define a series of biological tests that evaluate how a material interacts with living tissue and biological systems. To earn USP Class VI certification, a material must pass three core evaluations:

Systemic Toxicity — Ensures the material does not release chemicals that cause harmful biological reactions when introduced into the body.
Intracutaneous Reactivity — Confirms that extracts from the material do not cause irritation or inflammation when injected into skin tissue.
Implantation Testing — Demonstrates that the material remains stable and non‑reactive when implanted in living tissue for a defined period.

These tests are performed using material extracts in multiple solvents (polar and non‑polar) to simulate real‑world exposure conditions. Passing USP Class VI testing indicates that the material is safe for direct or indirect contact with biological systems.

Why Manufacturers Need USP Class VI Silicones

For medical and pharmaceutical applications, USP Class VI compliance is often a baseline requirement. Materials that meet this standard offer:

High biocompatibility for medical devices, tubing, gaskets, and seals
Low extractables and leachables, reducing contamination risk
Compatibility with sterilization methods such as autoclave, gamma radiation, and ethylene oxide
Regulatory confidence, supporting FDA submissions and quality audits

ElastaPro’s silicone and fluorosilicone materials are engineered to meet or exceed these requirements, and they also comply with ISO 10993 and other standards.

USP Class VI Silicone Applications

Materials that meet USP Class VI Requirements are commonly used in:

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

How ElastaPro Supports Regulatory Compliance

ElastaPro supplies a wide range of silicone and fluorosilicone materials engineered to meet USP Class VI Requirements. Our capabilities include:

Custom compounding for specialized purity, durometer, or performance needs
Precision molding and extrusion for medical‑grade seals and components
Material traceability and documentation to support regulatory submissions
Rapid prototyping for development and validation cycles

Whether you need sheet stock, molded parts, or custom‑engineered sealing solutions, ElastaPro delivers materials that meet stringent biocompatibility and purity standards.

Other 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.

USP Class VI Sealing Products for Medical Devices

There are seven major types of USP Class VI sealing products.

O-rings
Gaskets
Diaphragms
Sealing Profiles and Extrusions
Sanitary Seals and Tri-Clamp Gaskets
Custom Molded Sheets
Valve Seats and Sealing Components

O-Rings

O-rings are the most common and versatile USP Class VI sealing products used in biomedical and pharmaceutical equipment.

Materials: USP Class VI–certified elastomers such as silicone, fluorosilicone, EPDM (ethylene propylene diene monomer), and FKM (fluoroelastomer). Silicone and EPDM are especially common due to their chemical resistance and cleanroom compatibility.
Applications: O-rings are used in syringe pumps, bioreactors, peristaltic pumps, chromatography systems, and aseptic connectors. Their circular geometry provides uniform compression and reliable sealing even under pressure cycling.
Key Benefits: Ease of installation, broad chemical compatibility, and resistance to sterilization methods such as autoclaving, gamma irradiation, and ethylene oxide (EtO) treatment.

Gaskets

Gaskets provide flat sealing between two rigid surfaces, typically flanges.

Materials: USP Class VI silicone sheets, PTFE (polytetrafluoroethylene) composites, and perfluoroelastomers (FFKM). PTFE-encapsulated silicone gaskets are often specified when chemical resistance and biocompatibility are both required.
Applications: Sterile process piping, pharmaceutical mixing tanks, bioprocessing skids, and clean-in-place (CIP) systems. In these environments, gaskets prevent contamination and maintain sterile boundaries.
Key Benefits: Large sealing surface, customizable geometry, and high resistance to process fluids ranging from solvents to biological media.

Diaphragms

Diaphragms are flexible membranes that separate two environments while allowing pressure or mechanical force to be transmitted.

Materials: USP Class VI–approved silicone, EPDM, or PTFE-lined elastomers. Some diaphragms are multilayer composites that combine flexibility with chemical inertness.
Applications: Diaphragm valves, pump heads, and pressure regulators in biopharmaceutical systems. They are especially critical in applications where sterility and purity must be maintained without direct fluid leakage.
Key Benefits: Smooth, crevice-free geometry that reduces bacterial entrapment; compatibility with sterilization; and long fatigue life under cyclic loading.

Sealing Profiles and Extrusions

Custom sealing profiles, sometimes referred to as extruded seals, are widely used in pharmaceutical isolators, medical enclosures, and sterile filling equipment.

Materials: USP Class VI silicone rubber is the dominant choice due to its flexibility, clarity (in translucent grades), and resistance to repeated sterilization. Thermoplastic elastomers (TPEs) are also used in some extrusion profiles.
Applications: Door seals in cleanrooms, chamber gaskets for lyophilizers, and perimeter seals for glove boxes. They maintain controlled atmospheres and prevent ingress of contaminants.
Key Benefits: Continuous lengths with minimal splicing, availability in bulb, U-channel, and custom geometries, and low compression set for long-term sealing.

Sanitary Seals and Tri-Clamp Gaskets

Sanitary seals are standardized USP Class VI sealing products used with hygienic fittings in biopharma and food processing.

Materials: USP Class VI silicone, EPDM, FKM, and PTFE. Some manufacturers also provide platinum-cured silicone versions, which reduce extractables compared to peroxide-cured variants.
Applications: Tri-clamp gaskets seal the joints in stainless-steel sanitary tubing systems. They are indispensable in dairy processing, vaccine production, and parenteral drug manufacturing.
Key Benefits: Easy assembly and disassembly for cleaning, compliance with both USP Class VI and FDA CFR 21, and surface finishes optimized for cleanability.

Custom Molded Seals

Not all sealing requirements can be met with standard geometries. Custom molded USP Class VI sealing products allow engineers to create shapes tailored to specific equipment.

Materials: USP Class VI elastomers including silicone, EPDM, and perfluoroelastomers. These can be compounded to balance mechanical properties with biocompatibility.
Applications: Seals for implantable devices, diagnostic cartridges, microfluidic platforms, and drug delivery systems. Custom seals often support innovations in life sciences where unique geometries are required.
Key Benefits: Optimized sealing performance, integration with device architecture, and scalability for high-volume production.

Valve Seats and Sealing Components

Beyond diaphragms, valve systems often require additional USP Class VI–compliant sealing parts such as valve seats, poppets, and bellows.

Materials: PTFE, perfluoroelastomers, or high-purity silicone. Material selection depends on chemical exposure and mechanical requirements.
Applications: Aseptic sampling valves, pinch valves, and dosing systems in sterile pharmaceutical manufacturing.
Key Benefits: High wear resistance, low extractables, and reliable sealing under dynamic movement and pressure cycling.

USP Class VI Silicone FAQs

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.

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.

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 are the major types of USP Class VI sealing products?