Medical-grade O-rings
O-Rings for Medical and Pharmaceutical Applications
In the rapidly evolving field of medical procedures and pharmaceutical manufacturing, reliable, high-quality O-rings play a critical role. These essential components support applications ranging from routine operations to life-saving innovative technologies, ensuring safety and performance even under varying chemical and temperature conditions. The medical and pharmaceutical industries face unique challenges when it comes to sealing solutions. These challenges include maintaining sterility, ensuring resistance to corrosive chemicals and biological environments, sustaining high-temperature stability, and meeting stringent cleanliness requirements.
Dedicated to Standards and Certified Quality
Adherence to specific standards and production conditions is key to overcoming these challenges. For example, USP Class VI certification indicates that the material has passed rigorous biocompatibility testing, meaning it can be safely used in a wide range of pharmaceutical, biotechnology and medical applications. USP Class VI O-rings therefore provide additional assurance of the material’s safety and suitability for use in these demanding environments.
Strictly adhering to the hygiene requirements of the medical and pharmaceutical industries, we offer custom-manufactured O-rings for cleanroom use. This ensures the sterility of our products from the very beginning of the manufacturing process, with production environments meeting international cleanliness standards of ISO 5, ISO 6, and ISO 8, satisfying different levels of hygiene application needs.
Simultaneously, we offer two distinctive product lines: FDA-compliant O-rings and metal-detectable O-rings. FDA-compliant products can be used in critical areas that come into direct contact with medications, meeting contact safety requirements;metal-detectable products can be detected by standard metal detection instruments, mitigating the risk of foreign object contamination at the source, and are suitable for high-cleanliness pharmaceutical production lines.
Integrating four core series—USP Class VI, cleanroom manufacturing, FDA compliance, and metal detection—our O-ring products precisely address the stringent challenges of the medical and pharmaceutical industries, enhancing equipment stability and production efficiency with high-performance sealing solutions, providing a solid guarantee for patient safety.
Pharmaceutical compliant sealing compounds: USP VI grade, FDA standard, metal detectable O-ring material
| Compounds | Material | Durometer | Color | Temp Range (F) | 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 |
| E70-B502 | EPDM | 70 | White | -67 to +257 | Medical Grade, PTFE 1% Internal Lubricant, FDA Compliant |
| F50-B401 | Fluorosilicone | 50 | Blue | -76 to +350 | FDA-Grade |
| F70-B401 | Fluorosilicone | 70 | Blue | -76 to +348 | FDA-Grade, UL 157 Certified |
| F70-B402 | Fluorosilicone | 70 | Blue | -76 to +348 | FDA-Grade |
| 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 +437 | FDA-Grade |
| S70-B001 | Silicone | 70 | Clear | -76 to +437 | USP Class VI Certified, Platinum Cured |
| S70-B401 | Silicone | 70 | Blue | -67 to +392 | USP Class VI Certified, ISO 10993-5 Compliant |
| 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 |
| V70-B501 | FKM | 70 | White | -4 to +482 | USP Class VI Certified |
| 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 |
In the medical and pharmaceutical fields, you can confidently choose KODA for your O-rings and complete sealing solutions. To place an order or learn more about our products, please call +86 18730921709, visit our online store, or fill out our product inquiry form to contact us.
