USP Class VI Seals
USP Class VI seals and O-rings are specified for applications where sealing materials require documented biological reactivity performance for pharmaceutical, medical, bioprocessing and other high-purity systems.
International Seal supplies USP Class VI compliant EPDM, FKM, FFKM and silicone seals and O-rings, sourced to suit demanding process and equipment requirements. We support customers requiring hygienic and high-purity sealing components with material documentation, traceability and technical support available according to the selected compound. From replacement O-rings to application-specific sealing requirements, our team can help identify a suitable material, size and specification for your equipment.
What is USP Class VI?
USP Class VI relates to biological reactivity testing of polymeric materials. USP General Chapter <88> covers in-vivo biological reactivity testing used to assess materials including elastomers and polymers.
For sealing applications, a USP Class VI requirement may be specified where materials are used in pharmaceutical processing, drug-contact equipment, high-purity systems or other controlled applications. USP Class VI suitability should always be confirmed against the exact compound and application rather than assumed from the base polymer alone.
USP Class VI Materials Available
| Material | Typical Considerations |
|---|---|
| EPDM | Commonly selected for pharmaceutical and hygienic processing applications involving water, hot water and steam, subject to compound specification |
| Silicone | Used where flexibility, cleanliness and suitability for controlled processing environments are important |
| FKM | Suitable where increased chemical resistance, oil resistance and elevated-temperature capability are required; compatibility with steam and cleaning media should be confirmed |
| FFKM | Selected for demanding applications requiring very broad chemical resistance and high-temperature capability; typically used where standard elastomers are unsuitable |
Typical Applications
USP Class VI sealing components may be used across:
- Pharmaceutical process equipment
- Medical equipment and fluid handling
- Hygienic pumps and valves
- Mixing and processing vessels
- Laboratory and analytical equipment
Available Seal Types
Depending on the application and compound requirements, International Seal can source and supply:
- O-rings
- Hygienic seals and gaskets
- Custom moulded seals
- Application-specific elastomer components
Documentation & Traceability
For regulated and high-purity applications, documentation can be as important as the component itself.
Depending on the selected material and supplier, documentation may include:
- USP Class VI material documentation
- Certificate of Conformance
- Material certification
- Batch or lot traceability
- FDA compliance documentation where applicable
FAQ
What USP Class VI seal materials do you supply?
International Seal supplies USP Class VI sealing components in selected FKM, FFKM, EPDM and silicone compounds. Material availability and certification should be confirmed for the specific component and application.
Can you supply USP Class VI O-rings?
Yes. USP Class VI O-rings can be supplied in suitable EPDM, FKM, FFKM and silicone compounds across standard and specialist sizes.
Do USP Class VI seals come with certification?
Relevant material documentation and certificates can be supplied depending on the selected compound and component. Tell us your documentation requirements when requesting a quotation.
Can you help identify the correct seal?
Yes. Send us your dimensions, drawing, existing part reference, operating conditions and required compliance documentation and we can help source an appropriate sealing solution.