When you're in the food, beverage, or pharmaceutical business, every component in your processing line matters. The hoses and tubing you use are in direct contact with your product, making their safety and compliance a non-negotiable part of your operation. But navigating the world of regulatory standards can be confusing. What does "FDA-compliant" actually mean?

At Flex Technologies, we are experts in engineering high-purity fluid transfer solutions. We understand that you can't afford to compromise on safety. This guide is designed to help you understand the basics of FDA regulations for food contact hoses so you can select the right products with confidence. Shop today.

Understand the Key Regulation: 21 CFR 177.2600

This is the most important regulation you need to know. When you see a hose described as "FDA-compliant," it is almost always referring to the Code of Federal Regulations, Title 21, Part 177.2600.

This rule specifies the requirements for "Rubber articles intended for repeated use" in contact with food. It outlines exactly which elastomers (like silicone) and additives are permitted. Most importantly, it sets strict "extractable" limits—a test that measures if any substances migrate from the hose into the food product. A custom silicone hose that meets this standard is proven to be non-toxic and will not alter the taste, smell, or composition of your product.

Know the Difference: "FDA-Compliant" vs. "FDA-Approved"

This is a critical distinction. The FDA "approves" finished products like new drugs or medical devices. The FDA does not "approve" materials or components like FDA-approved hoses.

Instead, materials like silicone are considered "FDA-compliant." This means the raw materials used to manufacture the hose are on the FDA's "safe list" and the finished hose meets the manufacturing and testing requirements of regulations like 21 CFR 177.2600. When you source FDA hoses from a reputable manufacturer, you are sourcing a product that is compliant with these federal safety standards.

Choose Platinum-Cured Silicone for Purity

The material and its manufacturing process are key. FDA silicone hoses are the industry standard for purity, but how they are made matters. Platinum-cured silicone is far superior to older, peroxide-cured methods for food and pharma applications.

The platinum-curing process leaves behind no byproducts, resulting in a purer, clearer, and more stable hose. This means our pharmaceutical silicone hoses are tasteless and odorless, ensuring your product's integrity.

Look for Higher Standards (USP Class VI)

For applications involving pharmaceuticals or biological solutions, you should look for tubing that meets an even higher standard: USP Class VI. While 21 CFR 177.2600 is for food, USP Class VI is a medical-grade standard that tests for biocompatibility and ensures the material is non-toxic and non-reactive in a biological system.

Many of our pharmaceutical hoses at Flex Technologies meet both FDA and USP Class VI standards, giving you the ultimate assurance of purity for your most sensitive applications.

Verify Temperature and Sterilization Compatibility

Your process likely involves hot liquids or clean-in-place (CIP) and sterilize-in-place (SIP) cycles. You need FDA hoses that can handle this without breaking down.

FDA silicone hoses are ideal because they have an extremely wide operating temperature range and are fully compatible with autoclaving (steam sterilization) and other common methods. This ensures you can maintain a sterile environment without degrading your equipment.

Always Demand Traceability and Documentation

Compliance isn't just about the product; it's about the paperwork. In a regulated industry, you must be able to prove your components are compliant. Always partner with a silicone hose and tubing manufacturer that can provide full lot traceability and certificates of compliance for their pharmaceutical silicone hoses and food-grade products. This documentation is your proof that you are meeting your regulatory obligations.

Your Partner in Compliance

At Flex Technologies, we specialize in manufacturing high-purity FDA-approved hoses and pharmaceutical hoses designed for these exact demands. Our platinum-cured silicone products are engineered for purity, durability, and full compliance, giving you the peace of mind you need to focus on what you do best. Shop today.

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