FDA-Certified Silicone Seals: The Foundation of Sanitary Medical & Food Processing Equipment

In medical and food industries, sealing solutions must meet two non-negotiable standards: absolute sanitation and strict regulatory compliance. Our custom FDA-grade silicone extruded gaskets and seals are engineered to exceed these requirements, providing a contamination-free barrier for critical equipment in cleanrooms, food processing lines, and medical facilities.

1. Critical Applications in Medical & Food Sectors

• Medical Cleanroom Enclosures: A Japanese medical equipment OEM relies on our sponge silicone seals for cleanroom walls and equipment housings. These seals are formulated to be non-toxic, low-outgassing, and resistant to autoclave sterilization (up to 135°C), ensuring they maintain integrity after repeated sanitization cycles.
• Food Processing Machinery: FDA 21 CFR 177.2600-compliant solid silicone seals are used in conveyors, mixers, and packaging machines. Their smooth, non-porous surface prevents bacterial growth, while resistance to acids, alkalis, and food-grade lubricants ensures long service life in wet, high-temperature environments.
• Autoclave & Sterilizer Doors: Our high-temperature resistant silicone gaskets create a hermetic seal for autoclaves and medical sterilizers, preventing steam leakage while withstanding repeated exposure to high pressure and heat. Custom profiles (such as P-shape or hollow tubes) are tailored to fit specific door geometries for a perfect seal.

2. Key Advantages of Our Medical/Food-Grade Silicone

• Regulatory Compliance: All seals meet FDA, CE, and ISO 10993 standards, ensuring compatibility with medical devices and food contact applications.
• Sanitary Design: Non-porous, smooth surfaces eliminate crevices where bacteria can accumulate, and the material is easy to clean with harsh sanitizers (including ethanol and hydrogen peroxide).
• Durability in Sterile Environments: Resists degradation from autoclaving, gamma radiation, and chemical sterilization, maintaining elasticity and sealing performance for years.

3. Customization for Unique Equipment Needs

We understand that medical and food equipment varies widely in design—our team works closely with OEMs to create tailored solutions:

• Adjust hardness (20A to 70A) for flexible seals that conform to uneven surfaces or rigid gaskets for heavy-duty doors.
• Add adhesive lamination (3M medical-grade tapes) for easy, tool-free installation on equipment frames.
• Provide pre-cut lengths or bonded O-rings to reduce assembly time and minimize waste. Whether you’re building a new cleanroom system or upgrading an existing food processing line, our FDA-grade silicone seals ensure your equipment meets the highest standards of sanitation and compliance.