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Medical Grade O-Rings & Biocompatible Sealing Solutions
Engineering high-precision, USP Class VI and FDA-compliant seals for critical medical devices, pharmaceutical processing, and life science applications.
- USP Class VI & FDA Compliant Materials
- ISO 7 (Class 10,000) Cleanroom Manufacturing
- Biocompatible & Sterilization-Ready
Advanced Sealing Solutions for the Healthcare Industry
In the medical and pharmaceutical sectors, the integrity of a seal is not just a matter of performance—it is a matter of patient safety. Oringworld provides specialized medical-grade O-rings designed to meet the most stringent regulatory requirements. Our seals are manufactured in ISO 7 (Class 10,000) cleanroom environments to ensure zero contamination and maximum biocompatibility.
| Material Type | Base Polymer | Temperature Range | Sterilization Methods | Key Certifications |
|---|---|---|---|---|
| Medical Silicone | VMQ (Platinum Cured) | -60°C to +230°C | Autoclave, Gamma, ETO | USP Class VI, FDA, ISO 10993 |
| Medical EPDM | Ethylene Propylene | -50°C to +150°C | Steam, Gamma, ETO | FDA 21 CFR 177.2600, USP VI |
| Medical FKM | Fluorocarbon (Viton) | -20°C to +200°C | ETO, Chemical | FDA, USP Class VI |
| Medical NBR | Nitrile | -30°C to +110°C | ETO, Gamma | FDA Compliant |
Engineering for Critical Medical Applications
Drug Delivery Systems
Our high-precision O-rings are used in insulin pumps, syringes, and auto-injectors where low friction and consistent sealing force are essential for accurate dosing.
Respiratory Equipment
We provide biocompatible seals for ventilators, oxygen concentrators, and anesthesia machines, ensuring no outgassing or harmful leachables enter the patient’s airway.
Surgical & Diagnostic Tools
From endoscopes to IVD diagnostic analyzers, our seals withstand aggressive cleaning agents and repeated sterilization cycles while maintaining mechanical integrity.
Frequently Asked Questions
What is the primary difference between FDA and USP Class VI compliance?
FDA 21 CFR 177.2600 focuses on the safety of materials intended for repeated use in contact with food or drugs. USP Class VI is a more rigorous biocompatibility protocol that involves systemic toxicity and intracutaneous testing, making it the gold standard for medical device components.
Are your medical O-rings produced in a cleanroom?
Yes, all our medical-grade seals are manufactured, inspected, and packaged in our ISO 7 (Class 10,000) cleanroom facility to prevent particulate contamination.
Can these seals withstand repeated Autoclave sterilization?
Our Platinum-Cured Silicone and specialized EPDM compounds are specifically engineered to maintain their physical properties through multiple steam sterilization (Autoclave) cycles.
Do you provide full material traceability?
Absolutely. Every shipment includes a Certificate of Analysis (COA) and full batch traceability, ensuring compliance with ISO 13485 quality management systems.