Gas Phase FDA Grade Silicone Rubber Sheet

What is Gas Phase FDA Grade Silicone Rubber Sheet?

Gas Phase FDA Grade Silicone Rubber Sheet is a premium, high-purity elastomeric material manufactured through an advanced gas phase polymerization process. This specialized production method results in a silicone rubber sheet of exceptional clarity, consistency, and purity, meeting the stringent requirements of the U.S. Food and Drug Administration (FDA) for repeated food contact. It is engineered for applications where material integrity, cleanliness, and compliance are non-negotiable, such as in food processing, beverage, pharmaceutical, medical device, and biotechnology industries.

Key Features and Manufacturing Process

The "gas phase" designation refers to the unique manufacturing process. Unlike traditional methods that may use peroxide or platinum catalysts in a liquid medium, the gas phase process involves reacting high-purity siloxane monomers in a controlled vapor state. This advanced technique offers significant advantages:

• Superior Purity: Eliminates the need for many traditional additives and catalysts that can lead to extractables and leachables, resulting in an extremely clean material.
• Exceptional Clarity and Consistency: Produces a sheet with outstanding optical transparency and uniform physical properties batch after batch.
• Excellent Thermal Stability: Maintains its properties across a wide temperature range, from extreme cold to high heat.
• Outstanding Compression Set Resistance: Returns to its original shape after prolonged compression, ensuring a reliable, long-lasting seal.

The "FDA Grade" certification confirms that this material complies with specific sections of Title 21 of the Code of Federal Regulations (CFR), such as 21 CFR 177.2600, for rubber articles intended for repeated use in contact with food. This makes it a trusted choice for gaskets, seals, diaphragms, and other components in food and beverage equipment.

Technical Specifications and Product Parameters

The following table details the key physical, mechanical, and thermal properties of our Gas Phase FDA Grade Silicone Rubber Sheet. These specifications are typical values and can vary slightly depending on the specific grade and durometer (hardness).

Available Grades and Forms

We offer this high-performance material in various forms to suit different application needs.

• Standard Sheets: Available in common thicknesses from 0.5mm (0.020") up to 6.0mm (0.250").
• Rolls: For high-volume production or continuous processes.
• Custom Die-Cut Parts: Precisely manufactured to your specifications and drawings.
• Adhesive-Backed Variants: Sheets with pressure-sensitive adhesive (PSA) for easy mounting and sealing.

Industry Applications

The unique combination of purity, performance, and compliance makes Gas Phase FDA Grade Silicone Rubber Sheet indispensable in numerous sectors.

• Food & Beverage Processing: Gaskets for tanks, pipes, valves, and pumps; Seals for homogenizers, fillers, and bottling machines; Conveyor belts and liners.
• Pharmaceutical & Medical: Seals and diaphragms in processing equipment; Components in diagnostic devices; Gaskets for sterilization autoclaves.
• Biotechnology & Life Sciences: Seals in bioreactors and fermenters; Tubing and connectors; Components in analytical instruments.
• Cosmetics & Personal Care: Seals in mixing and dispensing equipment for lotions, creams, and other products.
• General Industrial: High-purity seals and gaskets in electrical enclosures, semiconductor manufacturing, and other controlled environments.

Comparison with Other Silicone Rubber Types

Understanding the differences helps in selecting the right material.

• vs. Peroxide-Cured Silicone: Gas phase silicone has lower levels of extractables and offers superior clarity and odor characteristics.
• vs. Platinum-Cured (HTV) Silicone: While platinum-cured silicones are also high-purity, the gas phase process can offer even greater consistency in ultra-high-purity applications and often has a superior compression set.
• vs. General-Purpose Silicone: General-purpose grades are not manufactured with the same level of purity control and are not typically certified for direct and repeated food contact.

Frequently Asked Questions (FAQ)

What does "Gas Phase" mean in the context of silicone rubber?

The term "Gas Phase" refers to the specific manufacturing process where the raw silicone materials are polymerized in a vapor or gas state, rather than in a liquid solvent. This advanced method results in a polymer with extremely high purity, exceptional clarity, and very low levels of volatile components and extractables. It is a superior process for creating silicone rubber intended for the most demanding applications in food, medical, and pharmaceutical industries.

What specific FDA regulations does this silicone sheet comply with?

This Gas Phase FDA Grade Silicone Rubber Sheet is formulated to comply with U.S. FDA regulation 21 CFR 177.2600, "Rubber articles intended for repeated use." This regulation outlines the requirements for rubber materials that come into repeated contact with food during processing, packaging, or holding. Compliance ensures that the material is safe for its intended use and will not impart odor, taste, or harmful substances to the food product.

Is this material also suitable for medical or pharmaceutical applications?

Yes, absolutely. In addition to its FDA compliance for food contact, this specific grade of silicone rubber has passed testing for USP Class VI Plastics. USP Class VI is the most stringent level of testing for plastics in the United States Pharmacopeia and is often a baseline requirement for materials used in pharmaceutical processing and medical devices that contact bodily fluids or are used as drug delivery components.

What is the maximum continuous operating temperature for this sheet?

The Gas Phase FDA Grade Silicone Rubber Sheet can withstand continuous operation at temperatures up to 232°C (450°F). It also maintains excellent flexibility and performance at extremely low temperatures, down to -60°C (-76°F). This wide service temperature range makes it suitable for applications involving heat sealing, sterilization (autoclaving), and cryogenic processes.

How does the compression set of this material benefit my application?

Compression set resistance is a measure of a material's ability to return to its original thickness after being subjected to a compressive force for a prolonged period. A low compression set value (≤ 15% in our specification) is critical for gaskets and seals. It means the seal will maintain its contact force and sealing capability over time, even after many cycles of compression and decompression, preventing leaks and ensuring long-term reliability and safety in your equipment.

Can this silicone rubber sheet be custom die-cut?

Yes, we offer comprehensive custom die-cutting services. We can precision-cut the Gas Phase FDA Grade Silicone Rubber Sheet into any complex shape, size, or configuration based on your technical drawings or samples. This service allows for seamless integration into your assembly process, reduces material waste, and ensures a perfect fit for your specific gasket, seal, or diaphragm requirements.

Does it come with an adhesive backing?

We offer this material both with and without a pressure-sensitive adhesive (PSA) backing. The adhesive-backed version typically features a high-performance, acrylic-based adhesive that is also designed for cleanroom and food-contact applications. This option simplifies installation and eliminates the need for separate adhesive application, providing a ready-to-install sealing solution.

What certifications, besides FDA, does this product carry?

In addition to FDA compliance under 21 CFR 177.2600, this material is certified to NSF/ANSI 51 for food equipment materials. It has also passed USP Class VI testing for biocompatibility. Many of our production facilities are also ISO 9001:2015 certified, ensuring a consistent and reliable quality management system for every batch produced.

How should I store this silicone rubber sheet to maintain its properties?

To preserve its properties and shelf life, the sheet should be stored in a cool, dry, and dark place, away from direct sunlight, ozone, and other strong oxidizing agents. The ideal storage temperature is between 15°C and 25°C (59°F and 77°F). It should not be stored under tension, compression, or in contact with sharp objects. When stored correctly, the shelf life is typically several years.

Is this material resistant to oils, fuels, and chemicals?

While Gas Phase FDA Grade Silicone Rubber has excellent resistance to many polar solvents, water, and alcohols, it has poor resistance to non-polar solvents such as oils, fuels, concentrated acids, and alkalis. For applications involving exposure to such chemicals, a different elastomer like FKM (Viton®) or FFKM (Kalrez®) may be more appropriate. We recommend consulting our technical team for specific chemical compatibility guidance.