O-Rings for Food Safe & Medical Applications

Global O-Ring and Seal Offers a Wide Variety of FDA-Compliant Products.

There is often confusion around the terms FDA-Grade, FDA-Compliant, FDA-Certified, etc. The Food and Drug Administration does not “certify” o-rings as a general policy. Rather, they publish guidelines to specify ingredients that can be used in rubber parts that may come in contact with food. It is then the manufacturer’s responsibility to certify that the parts they provide are “FDA-Compliant” by issuing a certificate stating such. To read more about medical-grade o-rings, click here.

What Does It Mean for a Rubber O-Ring to Be FDA-Compliant?

FDA-Compliant means passing the Code of Federal Regulations, specifically CFR21.177.2600, which covers dry foods, liquids, and fatty foods. Dry foods must meet formulation and curation criteria under conditions of good manufacturing practice as appropriate for repeated use. Liquids must meet extraction criteria for not exceeding 20 mg/sq inch in distilled water. Finally, fatty foods must meet additional extraction criteria of not exceeding 175 mg/sq inch in n-hexane.

Beyond meeting the dry, liquid, and fatty food extraction criteria, several other nuances must be understood.

Material Source: FDA-compliant o-rings must be made from raw materials sourced from FDA-approved suppliers. This ensures the traceability and safety of the raw materials used in production.

Manufacturing Process: The manufacturing processes for FDA-compliant o-rings must adhere to strict cleanliness and contamination prevention standards. This can include using dedicated equipment, clean rooms, or specific handling procedures to avoid potential sources of contamination.

Post-Production Treatments: Any post-production treatments or finishes, such as surface treatments or lubricants, must also be FDA-compliant.

Continuous Compliance: Compliance isn’t a one-time event. FDA-compliant o-rings must be regularly tested and reviewed to ensure ongoing compliance, as regulations can change over time.

The Importance of FDA Compliance

Adhering to FDA compliance is critical. The FDA establishes standards to ensure products that come into contact with food or drugs are safe and free from harmful contaminants. Non-compliance can lead to health risks, legal consequences, and harm to a company’s reputation.

  • Regulatory Audits: Non-compliance can lead to disruptive and costly audits or inspections by regulatory bodies. Regular audits could be part of the business operations for industries relying heavily on FDA-grade o-rings.
  • Market Access: Compliance with FDA standards can be a prerequisite for access to certain markets or clients. Without it, you may be limiting your business opportunities.
  • Consumer Trust: Compliance fosters trust with end consumers who may seek out products explicitly stating the use of FDA-compliant components. This could be particularly relevant in sectors like the food industry or pharmaceuticals.
  • Environmental Impact: FDA standards also consider environmental impact. By adhering to these standards, businesses contribute to sustainable and responsible practices.

FDA-Grade O-Ring Compounds

Global O-Ring and Seal offers several FDA-Grade products, including FDA-Grade Cord compounds. If you do not see the compound you are looking for in the table below, please fill out the form on this page or call us with any special FDA-compliant product requests. Our FDA Declaration of Compliance can be viewed here.

Compounds
Material
Durometer
Color
Temp Range (F)
Data Sheet
Description
Chemraz SD625 FFKM 80

Black

-4 to +500 FDA-Grade, Heat/Chemical resistance
E70118 EPDM 70

Black

-67 to +257 FDA Compliant, NSF 61
E75YL12 EPDM 75

Yellow

-67 to +257 Metal/X-ray detectable, FDA-Grade
F50 Fluorosilicone 50

Blue

-76 to +350 FDA-Grade
F70323 Fluorosilicone 70

Blue

-76 to +350 FDA-Grade, UL 157 Certified
N70118 NBR 70

Black

-40 to +212 NSF 61, FDA
N70312 NBR 70

Blue

-40 to +212 Metal/X-ray detectable, FDA-Grade
N70710 NBR 70

White

-40 to +212 General purpose, FDA-Grade
N75GR12 NBR 75

Green

-40 to +212 Metal/X-ray detectable, FDA-Grade
P9082E FFKM 70

White

+14 to +500 Heat/Chemical resistance, FDA, USP Class VI Certified
S50 Silicone 50

Red

-76 to +437 FDA-Grade
S60610 Silicone 60

Red

-76 to +437 FDA-Grade
S70610 Silicone 70

Red

-76 to +437 FDA-Grade
S75612 Silicone 75

Red

-76 to +437 Metal/X-ray detectable, FDA-Grade
TEF PTFE 55-60 Shore D

White

-328 to +482 FDA-Grade, high heat/chemical resistance
TES FEP Silicone 85-90

Red

-76 to +428 Teflon-Encapsulated, FDA-Grade, high/low temp resistance
TEV FEP Viton 90-95

Black

-76 to +428 Teflon-Encapsulated, FDA-Grade, oil/fuel resistance
PFAS PFA Silicone 85-90

Red

-76 to +428 Teflon-Encapsulated, FDA-Grade, high/low temp resistance
PFAV PFA Viton 90-95

Black

-76 to +428 Teflon-Encapsulated, FDA-Grade, oil/fuel resistance
V75BL12 FKM 75

Blue

-15 to +450 Metal/X-ray detectable, FDA-Grade

Applications of FDA-Grade O-Rings

FDA-Grade o-rings are used in industries where sanitation and safety are paramount. Here are some common applications:

  1. Food & Beverage Industry: Used in food processing and beverage dispensing systems to ensure the purity and safety of consumables.
  2. Pharmaceutical Industry: Essential in pharmaceutical manufacturing and processing equipment to prevent contamination and ensure the efficacy of medications.
  3. Dairy Industry: Ideal for equipment used in milk and cheese production due to their ability to meet strict sanitation standards.
  4. Cosmetic Industry: Used in producing cosmetics and personal care products to prevent contamination and ensure product safety.

Note: The Food & Drug Administration does not individually approve specific products to CFR 21.177.2600. The manufacturer of the complete FDA-Grade product is the designated entity to furnish an FDA certificate as evidence of its compliance. Furthermore, while a manufactured part may be FDA-grade material, one should not infer that the part fits its intended technical application.

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