Specialty Polymers for Surgical Devices
With over 30 years of experience as a leading materials supplier to the healthcare industry, Solvay continues to provide sophisticated, reliable, high-performance specialty polymers for surgical instruments and sterilization cases and trays. To meet the demands of the industry, Solvay’s medical grade plastics provide OEMs with cost-effective metal alternatives that offer exceptional impact strength, heat tolerance, stiffness and sterilization compatibility for a variety of surgical applications.
Our broad portfolio of versatile specialty polymers facilitates excellent design flexibility and ease of processing in molding, extrusion and thermoforming. Solvay’s sophisticated materials provide applications with an aesthetically smooth surface finish, transparent and opaque grades and colorability for specialized branding or organization methods. Additionally, Solvay’s array of biocompatible materials for surgical instruments are engineered to provide single use instruments, reusable instruments, cases and trays with high impact strength, extraordinary mechanical performance, outstanding chemical resistance and flexible customization.
Solvay’s line of specialty polymers for surgical devices meets and exceeds our partners’ highest standards for safety and quality. All of these medical-grade polymers are thoroughly tested for biocompatibility under ISO 10993:1 and demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity. Our high-quality polymers retain their excellent performance properties and reliability through all conventional sterilization methods, including steam, ethylene oxide, vaporized hydrogen peroxide and gamma radiation: Impact strength • High strength and stiffness • Low dielectric constant • Excellent sterilization and disinfectant compatibility.
This line of high-performance plastics for surgical devices provides certified, reliable materials for a variety of applications, including handles, knobs, grips, trials, cases, trays, forceps, inserters, retractors, extractors, lids and surgery kits.
Single Use Surgical Device Thermoplastics
The tensile strength and ergonomic properties of Ixef® PARA (polyarylamide) and Udel® PSU (polysulfone) make them outstanding choices for single use instrument materials. Ixef® PARA and Udel® PSU exhibit extremely impressive mechanical performance and are compatible with cost-effective steam sterilization methods. These specialty polymers are utilized in an array of single use surgical instruments, such as curettes, inserters, needle holders, forceps, lids and surgery kits.
Reusable Surgical Device Thermoplastics
Solvay’s specialty polymers for reusable instruments include Radel® PPSU (polyphenylsulfone), AvaSpire® PAEK (polyaryletherketone) and KetaSpire® PEEK (polyetheretherketone). These high-performance medical-grade polymers offer unparalleled strength and toughness combined with high-temperature tolerance and chemical resistance to support surgical instruments that require repeat use and repeat-cycle steam sterilization. Radel® PPSU, AvaSpire® PAEK and KetaSpire® PEEK are resiliently capable of withstanding repetitive use and sterilization methods without any significant loss of physical or mechanical properties. Solvay offers these materials for reusable plastic surgical instruments such as handles, knobs, grips, trials, cases, trays, and retractors.
Extraordinary Strength and Stiffness
Both single use and reusable plastic instruments, cases and trays require superb strength and rigidity to compete with and outperform traditional metallic applications. The tensile strength of Ixef® PARA mimics that of cast metals and alloys, which makes it an ideal polymer for single use, plastic surgical instruments such as inserters, forceps, retractors and extractors. Both Radel® PPSU and AvaSpire® PAEK provide reusable surgical instruments with unparalleled stiffness and strength that elongate finished-product life and enhance performance.
Superior Sterilization Compatibility
Solvay specialty polymers for surgical devices are examined for gamma sterilization compatibility under USP Class VI testing and compatible with a wide range of applicable steam sterilization methods. Ixef® PARA is compatible with high-energy, bulk gamma sterilization which reduces cost and offers a quick turnaround to market. Additionally, polymer instruments made with Radel® PPSU and Udel® PSU can withstand repeat-cycle steam sterilization due to their high-temperature tolerance and excellent hydrolytic stability.
Excellent Chemical Resistance
Surgical instruments demand chemically resistant materials to withstand the harsh environments during washing and disinfecting processes prior to autoclaving. Solvay’s steam sterilizable plastics have superior chemical properties and retain their high-performance capabilities after disinfection. Radel® PPSU and AvaSpire® PAEK provide reusable sterilizable instruments with superior chemical resistance and maintain their physical properties and mechanical performance through repeat-chemical exposure.
Colorability And Customization
Solvay’s specialty plastics for medical devices and instruments are available in several colors and grades, which facilitates an array of unique branding opportunities and organization methods. Radel® PPSU exists in a wide range of both transparent and opaque colors. Ixef® PARA is available in a multitude of gamma-stabilized colors, which simplifies the differentiation of single use surgical instruments in spinal surgery kits. Additionally, AvaSpire® PAEK combines excellent aesthetics and colorability to allow for ample customization and a variety of high-performance grades.
Specialty Polymers for Surgical Devices
Radel® PPSU (polyphenylsulfone) is the highest performing sulfone polymer of its class, as it provides unparalleled strength, exceptional chemical resistance and outstanding mechanical performance. This amorphous thermoplastic is compatible with repeat-cycle steam sterilization because of its high temperature tolerance and excellent hydrolytic stability for plastic surgical instruments. Radel® PPSU maintains its properties through 1,000 cycles of steam autoclaving and supports a variety of cleaning and disinfection techniques. Solvay tests this specialty polymer under USP Class VI testing to ensure its ability to maintain properties following gamma sterilization. Radel® PPSU is available in glass fiber-reinforced grades as well as in a variety of opaque and transparent colors.
The unmatched strength and durability of Radel® PPSU make it a superb specialty polymer for reusable instruments used by the surgeon, such as handles, knobs, trials and grips. Additionally, Radel® PPSU enables cases and trays to retain their toughness and withstand broad temperature ranges during repeat sterilization and disinfection.
Ixef® PARA (polyarylamide) is a high-performance specialty polymer that provides rigidity, dimensional stability and metal-like strength for plastic surgical instruments. The properties of this sophisticated polyamide combine tensile and flexural strength with an aesthetic, ultra-smooth finish. These advanced qualities allow Ixef® PARA to withstand high-energy gamma radiation without significant changes to its original physical appearance or properties. Additionally, Ixef® PARA can be sterilized in bulk, which helps to reduce costs and enables OEMs to produce affordable, single use surgical instruments. Solvay offers Ixef® PARA in a wide range of gamma-stabilized (GS) colors that facilitate the differentiation of surgical instrument sizes and present OEMs with unique branding opportunities. These GS resins are tested under ISO 10993:1 for biocompatibility and demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity.
Solvay’s Ixef® PARA supports a multitude of single use, polymer surgical instruments such as inserters, curettes, needle holders, forceps, retractors and extractors. Additionally, Ixef® PARA is ideal for single use spinal surgery kits that enhance operating room efficiency, eliminate reprocessing costs and play an essential role in reducing the root causes of surgical site infections.
AvaSpire® PAEK (polyaryletherketone) is a family of customized high-performance polyketones that fill cost and performance gaps between classes of other medical grade plastics. This enhanced thermoplastic offers superior chemical resistance and mechanical properties that can be reinforced by glass or carbon fiber. The improved ductility and toughness of AvaSpire® PAEK paired with its excellent aesthetics and colorability produces a variety of grades that outperform comparable PEEK (polyetheretherketone) polymers. AvaSpire® PAEK offers an unparalleled combination of stiffness, strength and chemical resistance at up to 30% lower cost than other PEEK materials used in reusable instruments.
AvaSpire® PAEK is used in a variety of applications such as cases, trays, knobs, handles and grips. The upgraded properties of AvaSpire® PAEK can be customized, tailored and reinforced with glass or carbon fiber to deliver cost-effective surgical instruments.
KetaSpire® PEEK (polyetheretherketone) incorporates Solvay’s enhanced polymer production technology to offer distinct performance advantages in a variety of grades. This specialty polymer displays the best combination of fatigue and chemical resistance and can operate at higher temperatures than comparable materials. Additionally, KetaSpire® PEEK provides single use plastic instruments with higher purity and improved toughness. This high-performance thermoplastic is available in neat grades, glass and carbon fiber reinforced grades, wear resistant SL grades and natural-colored powders. These outstanding properties enable KetaSpire® PEEK to replace metal in surgical instruments used in severe end-use environments. KetaSpire® PEEK is examined for gamma stability under USP Class VI testing for compatibility with the most relevant single use sterilization methods.
KetaSpire® PEEK is used in various surgical applications such as handles, knobs and grips. Glass fiber and carbon fiber reinforced KetaSpire® PEEK grades deliver excellent mechanical robustness required for more demanding, reusable structural applications.
Udel® PSU (polysulfone) is a high-performance thermoplastic that offers a superior combination of thermal stability, high strength and toughness. This rigid, semi-tough, transparent thermoplastic offers enhanced stiffness and excellent biocompatibility. Udel® PSU resins provide polymer instruments with higher heat resistance and better hydrolytic stability than polycarbonate, which makes them steam sterilizable. This high-performance specialty polymer meets the industry standard for gamma sterilization under USP Class VI Testing.
Udel® PSU excels in fluid handling applications such as membranes, heart valve sizers, retractors, final product bags and lids used for containment.