FDA, USP Class VI, and NSF 61: Demystifying Sanitary Material Compliance for Seals and Gaskets

Choosing the right seal or gasket for hygienic applications involves more than just picking a material that fits. In industries like food and beverage, pharmaceutical manufacturing, and drinking water systems, regulatory compliance is critical. But with so many overlapping standards; FDA CFR 21, USP Class VI, NSF 51, NSF 61, 3-A Sanitary, and more; engineers and purchasing managers are often left wondering: which compliance matters most?

This guide breaks down the most common sanitary material standards for elastomeric and plastic seals, gaskets, and custom components. We'll explain what each certification means, which materials typically meet them, and how Canyon Components can help you choose the right compliant solution.

Why Compliance Matters for Sealing Materials

In regulated industries, seals and gaskets are in direct contact with consumable products or critical process fluids. Choosing the wrong material can result in:

• Contamination of food, pharmaceuticals, or drinking water
• Regulatory violations and recalls
• Equipment damage from chemical incompatibility
• Process downtime due to premature failure

Using certified, traceable materials minimizes risk, ensures cleanability, and simplifies validation during inspections. For manufacturers undergoing regular audits by the FDA, USDA, or third-party certifiers, using compliant materials is essential not only for product safety but also for maintaining certifications and customer trust.

Overview of Common Standards

FDA CFR 21.177.2600

This section of the U.S. Code of Federal Regulations defines the requirements for elastomeric materials (rubbers) used in repeated contact with food. It includes testing for:

• Extractables in aqueous and fatty foods
• Temperature and time exposure limits
• Acceptable curing agents and fillers

Materials must be compounded with only approved ingredients and must not leach unsafe levels of substances when exposed to food. FDA compliance does not mean a part is "FDA certified", only that it is made from a compliant material.

Typical Materials: FDA grades of EPDM, Silicone, FKM (Viton®), FFKM Perfluoroelastomer (Kalrez®, Canrez®), and PTFE (Teflon®)

These materials are widely used for food processing equipment like pumps, mixers, valves, and storage systems. In many cases, companies will request FDA compliance even for non-food-contact parts to simplify procurement or meet distributor preferences. Learn more about FDA Compliant Materials here.

USP Class VI

USP (United States Pharmacopeia) <87> and <88> outline the testing required for medical and pharmaceutical materials. Class VI is the highest level of biocompatibility testing and includes:

• Systemic toxicity
• Intracutaneous reactivity
• Implantation testing in animals

These tests ensure materials do not cause adverse reactions when in contact with living tissue or bodily fluids. USP Class VI is often required for seals and gaskets used in drug manufacturing, biotech, and medical device assembly.

Typical Materials: Platinum-cured silicone, FKM, FFKM, PTFE, cleanroom-manufactured parts

It is important to note that Class VI compliance refers to the material, not the final part. If an O-ring or gasket is made from a Class VI-certified material but is cut or handled in a non-cleanroom environment, it may still be disqualified from certain pharma or medical use cases. Learn more about USP Class VI Materials here.

NSF 51 and NSF 61

NSF (National Sanitation Foundation) standards certify materials and components for contact with food and drinking water.

• NSF 51: Covers food equipment materials. Focuses on cleanliness, durability, and nontoxicity.
• NSF 61: Applies to materials and parts used in potable water systems (e.g., valves, gaskets, meters). It includes testing for extractables and heavy metals.

Many municipalities and OEMs require NSF-certified materials for parts installed in plumbing systems, water filtration, beverage dispensers, and similar products.

Typical Materials: NSF 61-certified EPDM, Silicone, Nitrile, certain plastics like PVDF and PTFE

NSF 61 has become especially relevant for OEMs selling into states with strict drinking water standards, such as California or Massachusetts. Even seemingly minor elastomeric parts in potable water systems are now being scrutinized for compliance.

3-A Sanitary Standards

The 3-A Sanitary Standards Inc. (3-A SSI) creates hygienic equipment design standards for the dairy, food, and beverage industries. While not a material certification per se, 3-A standards require the use of FDA-compliant materials and prescribe:

• Cleanable, crevice-free design
• Non-absorptive materials
• Durable performance under CIP (clean-in-place) conditions

Gasket materials in 3-A applications must resist caustic cleaners, hot water, and repeated disassembly. 3-A certification is often required by dairy processors, breweries, and food packaging companies. Learn more about 3-A Sanitary Materials here.

When to Use Which Standard

Application	Standard(s) to Consider
Food and Beverage Seals	FDA CFR 21, NSF 51 & NSF 61, 3-A Sanitary
Pharmaceutical Manufacturing	USP Class VI, FDA CFR 21
Drinking Water Systems	NSF 61, FDA CFR 21
Biotech and Lab Equipment	USP Class VI, FDA CFR 21
Dairy, Brewing, CIP Systems	3-A Sanitary, FDA CFR 21, NSF 51
Cleanroom/Medical Devices	USP Class VI, ISO 10993-1

It’s worth noting that many regulatory authorities (FDA, EPA, Health Canada, etc.) consider NSF and USP standards as trusted benchmarks, even if they don’t directly enforce them. For end-users and OEMs, using compliant materials is also a way to reduce liability and improve market access.

Canyon Components: Sanitary-Compliant Materials

Canyon Components offers a full range of compliant materials, including:

• FDA CFR 21.177.2600-compliant EPDM, Silicone, Nitrile, FKM, and FFKM
• USP Class VI platinum-cured silicone, Canrez FFKM, and cleanroom packaging
• NSF 61 EPDM and plastic components
• PTFE and PFA materials suitable for multi-standard compliance

We also provide documentation packages including lot traceability, certificates of conformance, third-party test data, and in some cases, validation protocols.

Featured Compliant Materials

• Platinum-cured Silicone: Used widely in pharmaceutical transfer tubing, O-rings, and gaskets. Offers low extractables and USP Class VI/ISO 10993 compliance.
• FDA-grade EPDM: Excellent for dairy and beverage systems. Compatible with hot water, steam, and CIP chemicals.
• FFKM (Kalrez®, Canrez®): For chemical resistance and biocompatibility in harsh pharmaceutical and biotech environments.
• PTFE and PFA: Chemically inert and commonly used where both FDA and USP compliance are required. Great for diaphragm seals and flange gaskets.

How to Verify Compliance

When sourcing seals and gaskets, compliance is only as reliable as the documentation that comes with the product. Canyon Components supports your quality assurance program by:

• Offering full material traceability
• Including certificates of conformance with lot numbers and compound data
• Providing USP Class VI or NSF test reports upon request
• Working with suppliers who maintain ISO 9001 and/or ISO 13485 certifications

This documentation is not only helpful for audits, but also ensures consistency in your manufacturing process.

Engineering Support for Regulatory Applications

Don’t leave material selection to guesswork. Canyon’s technical sales and engineering team can assist with:

• Specification matching: Help decipher customer specs, RFQs, or government contracts
• Material cross-referencing: Replace discontinued or long-lead materials with compliant alternatives
• Design optimization: Recommend geometry changes that reduce risk of contamination or improve cleaning efficiency
• Process validation: Supply test samples or documentation required for equipment qualification or FDA submission

If your application involves validation, sterilization, traceability, or risk management, it pays to work with a partner who understands these nuances.

Conclusion

FDA, USP Class VI, and NSF 61 are just a few of the standards that apply to sanitary seals and gaskets. Understanding the scope and intent of each can help you avoid non-compliance, reduce risk, and ensure safe product contact.

Whether you need a single FDA-grade O-ring or a full suite of validated components for a pharmaceutical cleanroom, Canyon Components has the materials, documentation, and expertise to help. We stock compliant materials, manufacture to exacting tolerances, and ship globally with full certification support.

Ready to specify compliant seals and gaskets? Request a Quote or contact our team to get started.