FDA Food Grade Silicone Rubber is a high-performance elastomer formulated to comply with 21 CFR 177.2600, a regulation governing rubber articles intended for repeated food contact . It is composed of non-toxic, odorless, and inert silicone compounds, making it ideal for applications where safety and hygiene are paramount. This material excels in extreme temperatures, chemical exposure, and demanding environments, ensuring long-term functionality without compromising food integrity.
Crafted from platinum-cured silicone, this rubber undergoes rigorous quality control to eliminate harmful additives like BPA or phthalates. The formulation includes FDA-approved fillers and vulcanizing agents, ensuring compliance with global food safety standards .
With a temperature range of -60°F to 450°F (-51°C to 232°C), this silicone rubber maintains stability in freezing conditions and withstands repeated sterilization processes . Its resilience to thermal stress makes it suitable for oven-safe bakeware, steam-resistant hoses, and high-heat industrial equipment.
The material resists degradation from acids, alkalis, oils, and solvents, ensuring no leaching of contaminants into food or beverages. This property is critical for applications in dairy processing, brewery equipment, and pharmaceutical manufacturing .
Meeting USP Class VI and ISO 10993 standards, the silicone rubber is biologically inert, making it safe for medical devices and direct contact with sensitive products like infant formula .
Tear Resistance: High tensile strength (5-8 MPa) ensures longevity in dynamic applications.
Abrasion Resistance: Resists wear and tear from frequent use or harsh environments.
UV and Ozone Resistance: Maintains elasticity and appearance outdoors or in sterilized settings .
Non-Porous Surface: Prevents bacterial growth and residue buildup, adhering to 3-A Sanitary Standards.
Easy Cleaning: Smooth texture allows for quick disinfection, critical in food processing and healthcare .
Available in Shore A hardness levels of 20-80, this rubber can be tailored for specific needs—from soft seals in medical devices to rigid components in industrial machinery .
Recyclable: Compliant with RoHS and REACH regulations, reducing ecological impact.
Low VOC Emissions: Safe for indoor use and sensitive environments .
Parameter | Range | Testing Standard |
Hardness (Shore A) | 20-80 | ISO 868 |
Tensile Strength | 5-8 MPa | ISO 37 |
Elongation at Break | 300-600% | ISO 37 |
Temperature Range | -60°F to 450°F (-51°C to 232°C) | ASTM D1565 |
FDA Compliance | 21 CFR 177.2600 | FDA |
Water Absorption | <1% | ISO 2285 |
FDA 21 CFR 177.2600: Ensures safe food contact and compliance with U.S. regulations.
ISO 9001: Demonstrates adherence to international quality management systems.
NSF/ANSI 51: Validates suitability for food equipment .
Manufactured in ISO 14644-1 Class 8 cleanrooms, the material undergoes:
Raw Material Testing: Gas chromatography ensures no harmful residues.
Precision Mixing: Computer-controlled blending for uniform consistency.
Secondary Curing: Removes volatile compounds, enhancing stability.
Final Inspection: Microscopic analysis and mechanical testing verify performance .
Each batch is accompanied by a Certificate of Compliance and Material Safety Data Sheet (MSDS), allowing full traceability from production to delivery.
A: Yes. It complies with FDA 21 CFR 177.2600, ensuring no harmful migration into food .
A: Absolutely. The material retains integrity after repeated exposure to steam sterilization at 250°F (121°C) .
A: When stored in a cool, dry environment, it has a 10-year shelf life without degradation .
A: No. Standard rubber handling practices apply, but avoid contact with petroleum-based lubricants to prevent swelling .
A: Yes. FDA-approved pigments are available for custom color matching without compromising safety .
Uncompromising Safety: Rigorous testing ensures compliance with global food and medical standards.
Longevity: Resists aging, UV rays, and chemicals, reducing replacement costs.
Versatility: Customizable for diverse applications, from delicate medical components to heavy-duty industrial parts.
Sustainability: Environmentally friendly production processes and recyclable material.
By integrating FDA Food Grade Silicone Rubber into your designs, you prioritize safety, performance, and regulatory compliance. Contact us today for tailored solutions that meet your exact specifications.
