FDA-Grade O-Rings

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
E70-B105	EPDM	70	Black	-67 to +257		FDA Compliant, NSF 61
F50-B401	Fluorosilicone	50	Blue	-76 to +350		FDA-Grade
F70-B401	Fluorosilicone	70	Blue	-76 to +350		FDA-Grade, UL 157 Certified
N70-B106	NBR	70	Black	-40 to +212		NSF 61, FDA
N70-B502	NBR	70	White	-40 to +212		General purpose, FDA-Grade
N70-C401	NBR	70	Blue	-40 to +212		Metal/X-ray detectable, FDA-Grade
N75-F701	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-B601	Silicone	50	Red	-67 to +437		FDA-Grade
S60-C601	Silicone	60	Red	-67 to +392		FDA-Grade
S70-A601	Silicone	70	Red	-67 to +392		FDA-Grade
S75-F601	Silicone	75	Red	-76 to +437		Metal/X-ray detectable, FDA-Grade
T60D-H501	PTFE	55-60 Shore D	White	-328 to +482		FDA-Grade, high heat/chemical resistance
V75-B106	FKM	75	Black	-13 to +482		FDA-Grade
V75-F401	FKM	75	Blue	-15 to +450		Metal/X-ray detectable, FDA-Grade
Z90-I101	FEP Viton	90-95	Black	-76 to +428		Teflon-Encapsulated, FDA-Grade, oil/fuel resistance
Z90-I102	PFA Viton	90-95	Black	-76 to +428		Teflon-Encapsulated, FDA-Grade, oil/fuel resistance
Z90-I601	FEP Silicone	85-90	Red	-76 to +428		Teflon-Encapsulated, FDA-Grade, high/low temp resistance
Z90-I602	PFA Silicone	85-90	Red	-76 to +428		Teflon-Encapsulated, FDA-Grade, high/low temp resistance

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.