Medical & Pharmaceutical Grade O-ring Materials

Sealing materials used in these sectors must comply with multiple international standards that ensure safety, biocompatibility, and traceability. Key requirements include USP Class VI testing for biological reactivity, ISO 10993 testing for cytotoxicity and systemic toxicity, and FDA CFR 21.177.2600 compliance for materials used in contact with food or pharmaceutical products. Additional approvals such as NSF 51 and 61, 3A Sanitary, and European Pharmacopoeia 3.1.9 may apply depending on the end-use. Canyon Components provides full documentation packages, including Certificates of Conformance, batch traceability, and test reports, to verify that each material meets or exceeds applicable standards. These materials are manufactured and packaged under controlled conditions to ensure consistency and purity at every stage of production. If you have any questions or require design assistance, feel free to reach out to the Canyon Components engineering team!

Medical-grade sealing components undergo more stringent manufacturing and quality control processes than general-purpose parts. Canyon Components produces many of these seals using clean compounding, molding, and post-curing techniques that eliminate contaminants, extractables, and residual chemicals. Typically we use dedicated tooling for medical-grade materials to prevent cross-contamination from industrial compounds. After molding, parts can be post-cured, plasma-treated, or washed in deionized water to achieve low particulate and low volatile residue levels. Components destined for sterile environments are further cleanroom packaged under ISO Class 7 or Class 8 conditions, ensuring they arrive contamination-free and ready for use in validated manufacturing or patient-contact systems. If you have any questions or require design assistance, feel free to reach out to the Canyon Components engineering team!

Material performance depends on both process media and sterilization method. FFKM materials like Canrez® and Kalrez® provide unmatched chemical resistance for use with solvents, acids, and sanitizing agents in aggressive clean-in-place (CIP) and steam-in-place (SIP) cycles. EPDM is preferred for water and steam handling systems because of its excellent hot-water and peroxide resistance. Silicone and fluorosilicone compounds are used in applications that require extreme temperature flexibility or transparency. FKM (Viton®) offers excellent sealing strength and resistance to oils and pharmaceutical solvents. Above all, Canyon Components offers compounds in each of these material categories that are USP class VI. Canyon Components helps customers evaluate each environment, whether it involves exposure to ethanol, saline, or sterilizing steam, to select the compound that provides the right balance of purity, elasticity, and chemical stability. If you have any questions or require design assistance, feel free to reach out to the Canyon Components engineering team!

Every batch of medical and pharmaceutical-grade materials is manufactured under strict process controls to maintain biological safety and cleanliness. Canyon Components uses raw materials certified to be free from animal-derived substances and latex to minimize allergen risk. Our biocompatible compounds are tested to verify that they do not cause cytotoxic, irritant, or systemic responses when exposed to living tissue. After molding, parts undergo cleaning procedures that remove surface residues and particulates. Components can also be sterilized or gamma-compatible upon request. These measures ensure that every seal meets the purity standards required for direct contact with drug products, biological materials, or medical fluids. If you have any questions or require design assistance, feel free to reach out to the Canyon Components engineering team!

Our materials are designed to maintain their sealing performance after repeated sterilization cycles. FFKM and FKM compounds handle the broadest range of sterilization environments, including high-pressure steam and chemical disinfectants. Silicone and EPDM exhibit excellent recovery and elasticity after steam autoclaving or ethylene oxide exposure. For gamma and e-beam sterilization, Canyon Components provides formulations with enhanced radiation stability to prevent brittleness or discoloration. We can also perform cycle testing to verify that materials retain mechanical integrity and compression set resistance after hundreds of sterilization rounds, ensuring consistent sealing performance throughout the life of the component. If you have any questions or require design assistance, feel free to reach out to the Canyon Components engineering team!

Yes. Single-use bioprocessing systems are increasingly replacing traditional stainless-steel equipment to reduce cleaning costs and contamination risk. Canyon Components supplies pre-sterilized, bagged, and labeled seals and gaskets suitable for single-use assemblies. These parts are produced from low-extractable silicone, EPDM, or TPE materials that meet USP and FDA standards. For tubing connections, manifolds, and disposable sensor housings, we can provide custom-molded geometries that maintain secure seals without adhesives or welds. Each batch is validated for dimensional accuracy, material compatibility, and sterility assurance, supporting rapid integration into single-use pharmaceutical production lines. If you have any questions or require design assistance, feel free to reach out to the Canyon Components engineering team!

Our medical-grade seals are used in diagnostic equipment, infusion systems, surgical instruments, respiratory devices, and various other medical devices. They provide consistent sealing in both dynamic and static applications where cleanliness and material stability are essential. For drug delivery systems and analytical equipment, we provide precision micro O-rings molded from USP Class VI materials. In reusable medical devices, we offer long-life elastomers and coatings that resist bodily fluids and sterilization cycles without hardening or swelling. Canyon Components also works with OEMs to co-develop custom seal geometries that optimize flow paths, minimize dead space, and maintain biocompatibility throughout repeated use. If you have any questions or require design assistance, feel free to reach out to the Canyon Components engineering team!

Canyon Components provides full traceability from raw material to finished part. Each shipment can include Certificates of Conformance, lot-specific batch records, USP and FDA compliance certificates, and detailed material data sheets. Our documentation supports audit readiness and regulatory validation for FDA and ISO 13485 quality systems. For global customers, we also offer EU 1935/2004 and REACH-compliant documentation to streamline cross-border regulatory approvals. This level of traceability ensures that every O-ring, gasket, or molded component can be confidently integrated into validated medical or pharmaceutical processes. If you have any questions or require design assistance, feel free to reach out to the Canyon Components engineering team!

Canyon Components combines material science expertise with manufacturing precision and regulatory understanding. We supply materials that meet the most stringent international standards while maintaining flexibility in design, tooling, and production. Our cleanroom packaging, extensive testing capabilities, and rapid prototyping services enable customers to bring compliant medical and pharmaceutical products to market faster. Whether you need FFKM seals for sterilization lines, silicone O-rings for diagnostic systems, or custom-molded parts for patient-contact applications, Canyon Components ensures that every component performs flawlessly, meets global compliance requirements, and supports the integrity and safety of critical healthcare processes. If you have any questions or require design assistance, feel free to reach out to the Canyon Components engineering team!