Specification Grade Silicones

FDA Approved Silicone

ElastaPro makes FDA approved silicone materials that meet requirements from the U.S. Food and Drug Administration (FDA). Choose these specification grade silicone materials in the solid silicone sheet or uncured silicone compound in the durometers, sizes, and colors that you need.

  • FDA approved solid silicone sheet arrives ready for die cutting and is between .010” to .500” thick and available in widths of up 60”. Sheets are available with a pressure-sensitive adhesive (PSA) backing and arrive ready for die cutting, flash cutting, waterjet cutting, or other gasket fabrication processes.
  • FDA approved uncured silicone compound arrives ready for curing and are available in low minimum order quantities (MOQs).

ElastaPro makes FDA grade white silicone and FDA grade translucent silicone for food contact applications. Both materials are available in 30, 40, 50, 60, and 70 durometer. FDA grade white silicone is also available in 80 durometer.

Why Use FDA Silicone?

Silicone rubber is one of the most versatile and reliable elastomers used today, especially in industries that demand safety, cleanliness, and durability. Among its many grades, FDA silicone rubber stands out for its compliance with stringent health and safety standards set by the U.S. Food and Drug Administration (FDA). This compliance makes it ideal for both food contact and medical applications, where materials must perform reliably without leaching harmful substances or degrading under harsh conditions.

Silicone rubber’s unique molecular structure—comprising alternating silicon and oxygen atoms—gives it exceptional thermal stability, flexibility, and resistance to chemicals and aging. It can withstand a wide temperature range, typically from -60°C to +230°C (-76°F to +446°F), without losing elasticity. It resists UV light, ozone, moisture, and microbial growth, making it suitable for both high-temperature sterilization and long-term exposure to demanding environments. Additionally, it maintains its mechanical integrity under compression, shear, and repeated flexing, which are common in seals, gaskets, and tubing.

What is FDA Silicone Rubber?

FDA silicone rubber refers to silicone compounds formulated and processed to meet the requirements of FDA CFR 21 §177.2600, which governs materials intended for repeated use in contact with food. To qualify, the silicone must not transfer any toxic or unsafe substances to the food or human body under normal use conditions. Typically, FDA silicone rubber is made from high-purity, platinum-cured formulations that are free of additives, plasticizers, or colorants that could pose contamination risks. The material is also odorless, tasteless, and chemically inert—key characteristics for use in regulated industries.

What Does CFR 177.2600 Entail?

  • Scope: The regulation applies to rubber articles used in various food-related processes, including producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food.
  • Material Requirements: It specifies that rubber articles should be made from natural and synthetic polymers and approved adjuvant substances (additives).
  • Compositional Limits: The regulation sets limits on the amounts of certain substances that can be used in the rubber articles, ensuring they are not present in amounts that could migrate into food.
  • Good Manufacturing Practices (GMP): Rubber materials must be manufactured under GMP to ensure consistent quality and safety.
  • Thorough Cleaning: Rubber articles must be thoroughly cleaned before their first use in contact with food.
  • Specific Extraction Requirements: For rubber articles intended to contact fatty foods, the regulation includes specific extraction limits when tested with n-hexane.
  • Examples of Approved Substances: The regulation lists various substances, including some elastomers like Buna (acrylonitrile-butadiene copolymer), silicone, and PTFE, as well as other additives.

FDA silicone rubber provides an optimal balance of safety, performance, and durability for food contact and medical applications. Its compliance with regulatory standards ensures that it does not compromise human health, while its physical and chemical properties support long-term reliability in demanding environments. Whether used in a milk processing plant, a hospital device, or a consumer kitchen appliance, FDA silicone rubber remains a trusted material that helps manufacturers meet both regulatory and engineering challenges. For engineers and product designers, it represents a high-performance, compliant material solution that bridges the gap between innovation and safety.

Benefits of FDA Silicone Materials

FDA-grade silicone materials are durable and adaptable, enabling manufacturers to utilize them in multiple applications. One of its best qualities is resistance to external elements like extreme heat and stressful environments. Because of this, it is widely used in producing gaskets and seals for food packaging. Below are the many other advantages of using FDA-approved silicone products.

Resistance to Extreme Temperature

Silicone is known for its heat endurance qualities. It can withstand extreme hot and cold temperatures, ranging from -80 °F to 550 °F, without yielding its durability and shape. Silicone developed its low thermal conductivity due to its highly stable chemical structure.

Resistance to Liquid and Chemicals

Silicone is not only heat resistant but also watertight. It also can resist food oils and most chemical types. Thus, food containers sealed using FDA silicone materials prevent leakage and food contamination.

Resistance to Environmental and External Elements

Because of their durability, FDA silicone materials can repel environmental and external elements like aging, ozonation, and weathering. This specific silicone feature helps foods sealed in silicone gaskets prolong their shelf life.

Free of Harmful Fillers

Some food containers and sealers contain toxic organic compounds like Bisphenol S and A (BPS, BPA) that could lead to increased blood pressure, cardiovascular diseases, type 2 diabetes, and other hormonal and obesogenic effects. Fortunately, silicones are non-toxic materials safe for food sealing and packing purposes.

Prevents Unwanted Physical Changes

Due to its food-grade status, silicone materials are less vulnerable to discoloration, deformation, odor, and other unwanted changes that could result in food contamination, making them unsuitable for consumption. Subsequently, they have antifungal and nonstick properties that help prevent mold or fungal decay.

Flexibility

Silicone’s flexible nature allows manufacturers to transform and mold it into custom sealing profiles, extending its usability to a broader spectrum of food applications.

Food Contact Applications for FDA Approved Silicone

In the food and beverage industry, FDA silicone rubber is used in products and components that must safely interact with consumables. Common examples include gaskets, seals, tubing, O-rings, and baking molds. Because it remains stable across wide temperature ranges, it performs reliably in both freezing and cooking environments. In processing facilities, it is used in dairy equipment, beverage dispensing systems, coffee machines, and sanitary seals for stainless steel piping. Its non-stick surface properties make it easy to clean and ideal for use in hygienic production lines where contamination control is critical.

Unlike many organic elastomers, silicone rubber does not degrade or impart taste or odor to food products. Its long service life and resistance to cleaning agents reduce maintenance costs and downtime, further enhancing its value in food processing operations.

FDA Silicone Food Applications

FDA-grade silicone materials have extensive functions and can be applied to several food-related purposes:

  • Gaskets for food processing machinery
  • Food transfer tubing
  • Dairy tubing and fluid handling
  • Vending tubing
  • Brewery tubing and seals
  • Antimicrobial belting
  • Commercial oven seals
  • Coffee machine tubing
  • Food-grade beverage gaskets
  • O-rings
  • Vibration pads
  • Electrical insulators

Medical and Healthcare Applications for FDA Approved Silicone

In medical and healthcare applications, medical-grade or healthcare-grade FDA silicone is often used in devices that contact the human body or bodily fluids. Examples include catheters, tubing, seals for diagnostic equipment, respiratory masks, and implantable components. Medical-grade silicone typically undergoes even more rigorous testing than food-grade silicone, often complying with USP Class VI and ISO 10993 biocompatibility standards in addition to FDA requirements.

These silicones can be sterilized using steam, ethylene oxide, or gamma radiation without significant property changes. They are also available in various formulations—solid, liquid (LSR), or sponge—allowing engineers to tailor the material to specific design requirements. For example, liquid silicone rubber is often injection molded into complex geometries for disposable medical devices, while solid silicone may be compression molded for reusable components.

FDA silicone refers to products that comply with the regulations set forth by the United States Food and Drug Administration (FDA). These regulations govern the safe use of silicone-based items in medical, pharmaceutical, food, and beverage applications. They also guarantee that the materials are non-toxic, chemically inert, and do not impart harmful substances into the products.

This article will explore the importance of FDA-approved silicone in various industries and the specific regulations and standards it must meet. ElastaPro makes FDA grade translucent silicone and FDA grade white silicone.

Significance of FDA Silicone Across Industries

FDA-approved silicone is pivotal across various industries due to its exceptional properties and adherence to stringent regulatory standards. In the food and beverage industry, this material is important to ensure the safety and quality of products. Its non-toxic nature prevents contamination and maintains the integrity of various food items, from processing equipment to packaging materials.

Using FDA silicone is also imperative in the pharmaceutical and medical sectors to uphold patient safety and regulatory compliance. Its exceptional biocompatibility, sterility, and resistance to chemical degradation make it indispensable in implants, catheters, and tubing. They are designed to be in direct contact with the human body for prolonged periods.

Furthermore, FDA silicone finds applications in various consumer products, from personal care items to industrial machinery. Its versatility and safety profile make it preferable for goods like baby bottle tubes, kitchen utensils, and automotive components. Manufacturers can instill consumer confidence regarding product safety by selecting this material for such applications.

Key-Considerations-in-FDA-Silicone-Materials

Regulations and Standards for Silicone Products

Compliance with the following regulations and standards is essential for silicone product manufacturers to ensure safety, effectiveness, and regulatory approval:

21 CFR Part 177

This regulation outlines the requirements for polymers including silicone intended for use in contact with food. It specifies permissible additives, maximum extractable levels, and overall safety criteria to prevent the migration of harmful substances into food.

USP Class VI

The United States Pharmacopeia (USP) Class VI standard applies to materials used in medical and pharmaceutical devices. Silicone products must meet cytotoxicity, sensitization, and systemic toxicity assessments to ensure they are safe for medical use.

ISO 10993

This international standard provides guidelines for evaluating the biological safety of medical devices, including silicone-based components. It encompasses various tests such as irritation, genotoxicity, and implantation tests to assess the compatibility of silicone materials with the human body.

ISO 9001 and ISO 13485

While not specific to silicone products, these quality management standards are relevant for producers of medical devices and pharmaceutical products incorporating silicone. Compliance with ISO 9001 ensures consistent quality control processes, whereas ISO 13485 focuses on meeting regulatory requirements for medical device manufacturing.

ISO 14971

This standard specifies requirements for risk management of medical devices, including those containing silicone. It entails identifying and mitigating hazards associated with silicone components, ensuring that risks are minimized.

FDA 510(k) Clearance

This process evaluates the safety and effectiveness of new medical devices compared to existing products. It ensures that silicone components meet regulatory requirements before being marketed in the United States.

FDA Master Files

Manufacturers may submit Master Files to the FDA containing confidential information about silicone materials’ safety, composition, and processing. These documents can streamline the regulatory review process for companies utilizing silicone product components.

 

 

 

 Get Exceptional FDA Grade Silicone From ElastaPro

Food safety doesn’t stop with food processing. Manufacturers should also consider using food-grade materials to keep their products fresh and free from harmful substances.

ElastaPro offers durable FDA-approved silicone sheeting ideal for making trustworthy silicone rubber gaskets and seals for safe and secured food packaging. Our products come in two varieties — FDA Grade (Translucent) Silicone Solid Sheet and GDA Grade (Pigmented) Silicone Sheet — and are compliant with CFR 177.2600, a section of the U.S. Code of Federal Regulations (CFR) with components for rubber articles intended for replicated use in contact with food.

Do you need a reliable FDA silicone materials supplier for your business? Partner with us today! ElastaPro has been around in the industry for decades, making us one of the silicone sheeting, compounding, and technology experts.

Contact us and get your high-quality FDA silicone from us!