Specialty Polymers for Healthcare
Solvay offers the industry’s broadest selection of high-performance thermoplastics for implantable and non-implantable medical devices. We also provide global technical and regulatory support.
With over 25 years of experience as a leading materials supplier to the healthcare industry, Solvay provides the commitment, experience and innovation that medical device manufacturers need from their partners.
Based on biocompatibility testing as defined by ISO 10993:1, our healthcare products demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity. Compatibility with various sterilization methods is product specific and includes gamma radiation, ethylene oxide, vaporized hydrogen peroxide and steam.
These categories represent areas where Solvay healthcare plastics are commonly used and do not imply fitness for use.
High-Performance Medical Grade Plastics
Performance requirements for medical equipment, cases and trays, surgical instrumentation and other non-implantable medical devices vary widely, but they share a common need for the high performance that Solvay’s medical grade plastics provide. These materials are suitable for limited exposure applications that are in contact with bodily fluids or tissue for less than 24 hours.
- Reusable and single-use devices
- Compatible with cleaning agents and disinfectants
- Transparent, opaque and gamma-stabilized colors
- FDA Master Access File (MAF) supported color palettes
- Silicon overmolding for ergonomic designs
- Enable metal-to-plastic conversion
|Orthopedics||Sterilization Cases &
|Reusable Medical & Dental Devices||Single-Use Surgical Instruments||Hemodialysis Membranes|
|Veradel® HC PESU||√||√||√|
Solviva® Biomaterials for Implantable Devices
Solviva® Biomaterials are offered for use in implantable medical devices, specifically those that are in contact with bodily fluids or tissue for more than 24 hours. Our dedicated production facility in Georgia, USA, is ISO 13485 compliant and operates under the relevant aspects of current Good Manufacturing Practices. All materials are tested in accredited laboratories that have ISO 9001 certification and are ISO 17025 accredited.
- Over 100 510(k) clearances and numerous CE marks
- Meets ASTM F2026-2016 (PEEK only) and YY/T 0660-2008
- Streamlined contract negotiations
- Ship directly to processors
- Process validation
- Product traceability
- Brands available: Zeniva® PEEK, Veriva® PPSU, Eviva® PSU
As a proactive partner with healthcare OEM’s for more than 25 years, we understand the stringent industry requirements designed to ensure biological safety and protect the public’s health, and we offer comprehensive regulatory support.
- Global standardization based on ISO 10993 methods
- Robust data dossiers, including FDA Master Access Files (MAFs) for materials used in long-term implantable and limited body contact applications
- Region-specific regulatory specialists can assist and support your submissions, petitions, and certificate requests
|Intracutaneous toxicity||ISO 10993-10||√||√||√||√||√||√|
|Acute systemic toxicity||ISO 10993-11||√||√||√||√||√||√|
|Subchronic toxicity||ISO 10993-11||√||√|
|Bone and muscle
(1)Including exhaustive extractions and risk assessment
|Radel® R-5000||Transparent, general purpose for injection molding|
|Veradel® HC A-301||Transparent, rigid, high-temperature, high-flow grade for injection molding|
|Udel® P-1700||Transparent, general purpose for injection molding|
|Udel® GF-120||20% glass fiber|
|Ixef® 1022||50% glass fiber, general purpose for injection molding|
|AvaSpire® AV-651||Better ductility and higher HDT than comparable PEEK, high melt flow for injection molding|
|AvaSpire® AV-651 GF30||30% glass fiber, better chemical resistance than AV-621, high melt flow for injection molding|
|AvaSpire® AV-651 CF30||30% carbon fiber, high melt flow for injection molding|
|KetaSpire® KT-880||High melt flow for injection molding, lubricated|
|KetaSpire® KT-880 GF30||30% glass fiber, high melt flow for injection molding|
|KetaSpire® KT-880 CF30||30% carbon fiber, high melt flow for injection molding|
Contact your Solvay representative for information specific to Solviva® Biomaterials
At Solvay, we understand the importance of responsive customer support and work hard to earn your confidence in us as a materials supplier. Our dedicated healthcare team provides the product development, technical and regulatory support you need to grow your global business. Please contact us for assistance with:
- Material recommendations
- Designing with plastics
- Moldflow® process modeling
- Finite element analysis
- Fabrication and assembly techniques
- Product testing
- Failure analysis
- Global regulatory submission assistance
Healthcare News & Events
High-performance Polymers for Orthopedic Implantable Devices and Surgical Procedures
Solvay offers the broadest selection of high-performance, medical-grade thermoplastics for limited exposure applications having less than 24 hours contact with bodily fluids and tissue. Solvay also offers Zeniva® PEEK and other Solviva® Biomaterials for long-term exposure applications that are in contact for more than 24 hours.
As a leading supplier of Specialty Polymers for Healthcare for over 30 years, we also offer the technical and regulatory support that medical device manufacturers need from a trusted partner.
What alternatives are there to PC and PEI? Learn how Sulfones compare in this Polymer Insights Webinar.
Polymer Insights: PC, PEI and Sulfones for Transparent Medical Applications
PC, PEI and PPSU are well-known transparent polymers for medical applications and represent an established good-better-best array of properties and values. But what about other high-performance options which may broaden the playing field? PSU and PESU bridge the gap in between key material attributes, such as: continuous service temperature; sterilization and heat resistance; chemical compatibility and mechanical performance.
In this half-hour webinar, our technical expert will explain data comparisons and case studies so you can learn how selecting the right sulfone polymer can increase design flexibility and strengthen your supply chain.
Solvay’s Zeniva® PEEK Enables a Durable All-Polymer Knee Implant from Okani
Okani Medical Technology, a China-based pioneer in artificial joint applications, developed its ORGKnee™ all-polymer knee implant, which leverages Solvay’s Zeniva® polyetheretherketone (PEEK) for the femoral and tibial tray components. Test simulations of the implant indicate that Solvay’s material helped reduce wear by 50 percent versus a metal implant as measured by material loss over 3 million cycles. (Photo courtesy of Okani Medical Technology)
Okani will detail these findings and others in two presentations scheduled for Monday, March 12 in Room Celestin D-E during the Orthopaedic Research Society (ORS) 2018 Annual Meeting | Download the program
Session 29 on Osteolysis and Adverse Soft Tissue Reaction
10:25 am: Peek Knee: In-Vivo and In-Vitro Studies
Session 39 on Implant Materials
2:35 pm: In Vitro Effects of the Wear Particles of Highly Cross-Linked Polyethylene, Polyether-Ether-Ketone, and Cobalt-ChromiumMolybdenum on Serum Cytokine Profiles and T-Cell Responses
Okani selected Zeniva® PEEK for the material’s success in spinal implant applications, as well as Solvay’s reputation for partnering with highly innovative medical device companies. Similar orthopedic applications announced by Solvay include:
Interested in other announcements about Zeniva® PEEK?
Solvay’s Ixef® PARA Enables ECA’s Single-Use Surgical Instrument Set for Use in One- and Two-Level Cervical Spine Implant Procedures
Solvay’s high-performance Ixef® polyarylamide (PARA) resin enabled ECA Medical Instruments to develop its Cervical-One™ single-use surgical instrument set for use in one- and two-level cervical spine implant procedures. Compared to reusable metal instruments, ECA’s single-use instruments can eliminate reprocessing costs, enhance operating room efficiency, streamline hospital and ASC inventory management, and play a significant role in eliminating the root causes of surgical site infections. (Photo courtesy of ECA Medical Instruments).
Compared to reusable instrumentation, single-use instrument systems like ECA’s can eliminate reprocessing costs, enhance operating room efficiency, streamline hospital and ASC inventory management, and play a significant role in eliminating the root causes of surgical site infections.
Despite concerns that single-use surgical instruments may have a negative impact on the environment vs. reusable metal tools, a study Solvay conducted in conjunction with Medacta International and Swiss Climate countered these perceptions. Read more about the study.
See other recent announcements about Ixef® PARA:
Specialty Polymers for Single Use Biopharma Processing Systems
Enabling Technologies that Improve or Sustain the Quality of Life
The developers and manufacturers of immunotherapies are employing innovative bioprocessing technologies and production technologies from the earliest, small-quantity trial stages to full-scale commercialization. The demands for quality, purity, scalability, flexibility and affordability are exceptional.
Single-use technology is uniquely suited to address these complex and multiple demands. Equipment changeover of plastic single-use equipment and components can be accomplished in hours instead of days—a fraction of the time and cost required for reusable, stainless steel equipment. Single-use eliminates the concerns about purity and contamination in reuse, as well as the water consumption, time and costs required for cleaning and cleaning validation.
Post Gamma Integrity
To ensure a pure environment, single-use equipment must be sterilized before use, and gamma irradiation is the increasingly preferred method. With some plastics, though, gamma sterilization causes concern about leachables and extractables, which can affect the purity and performance of biomaterials in processing and in patients.
At Solvay, we are committed to providing customers with post-gamma testing documentation for our broad portfolio of high-performance polymers that demonstrates the absence of leachables and extractables and retention of mechanical properties after gamma irradiation.
Key Benefits of our Portfolio
- Diverse range of gamma stable, medical-grade polymers
- ISO 17025 testing laboratories
- ISO 10993, USP Class VI, and post-gamma USP Class VI testing
- Post-gamma radiation mechanical performance test data available
- BPOG test protocols for worst case scenario
- High/low temperature stability and strong mechanical properties
- Less swelling than silicon or polyethylene
- Low protein and small molecule absorption
- Good flow characteristics
- Hydrophobic and hydrophilic materials for filtration
|Polymer Solutions||Connectors & Valves||Tubing||Gasket &
|Sensor Housing & Components||Stiring & Mixing Elements||Needles, Sheaths & Housings|
|Polymer Solutions||Membranes & Membrane
|Membrane Supports &
|Solvay Solutions||Bioreactors||Final Product Bags|
|Ixan® PVDC, Diofan® PVDC||✓||✓|
Solviva® Biomaterials Implantable Medical Devices
Solviva® is a family of biomaterials offered for use in implantable medical devices. Only products designated as part of the Solviva® family of biomaterials may be considered as candidates for medical applications implanted in the human body and devices that are in contact with bodily fluids or tissues for greater than 24 hours.
Solviva® Biomaterials meet or exceed the highest industry standards in terms of quality and biological safety. Products are available for prolonged exposure (greater than 24 hours to less than 30 days) and permanent exposure (greater than 30 days) to bodily fluids and tissue in the human body.
Solviva® products can be sterilized using all conventional sterilization methods, including gamma radiation, ethylene oxide and steam.
More to Offer than PEEK
The Solviva® family of biomaterials includes four distinct polymer chemistries, providing more options for meeting the needs of implantable devices used in orthopedics, cardiovascular, spine and more.
Zeniva® PEEK (polyetheretherketone) is one of the most biostable plastics available with high strength and stiffness plus excellent toughness and fatigue resistance. Zeniva® PEEK meets the requirements of ASTM F2026-07 as a polyetheretherketone (PEEK) polymer for surgical implant applications.
Comparison of stiffness-to-weight ratios
Veriva® PPSU (polyphenylsulfone) provides unsurpassed toughness combined with transparency and excellent biocompatibility.
Eviva® PSU (polysulfone) offers practical toughness in a strong, transparent polymer. It is also available in opaque white.
Solviva® Biomaterials are available directly from Solvay in both injection molding resins and stock shapes. Please contact us for individual data sheets.
|Injection Molding Resin||
The entire line of Solviva® Biomaterials is manufactured in compliance with ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.
Solviva® Biomaterials, as medical device raw materials, are considered biocompatible based on the requirements of ISO 10993-1:2009 for long term implants. Detailed Master Access Files (MAF) are registered with the FDA to support our customer’s submissions for regulatory clearance.
For more information regarding biocompatibility testing of Solviva biomaterials, please contact our technical experts.
Veradel® HC PESU
Solvay Expands Offering for Healthcare Polymers
In response to strong customer demand, Solvay has added Veradel® HC A-301 polyethersulfone (PESU) to its portfolio of high-performance healthcare polymers. It is the industry’s first PESU polymer to offer an FDA Master Access File (MAF) for medical devices.
Veradel® HC A-301 PESU retains its transparency and toughness at high temperatures and offers processing advantages over other commercial transparent polymers.
- Housings and internal structural components for medical diagnostic equipment
- Monitoring and filtration equipment
- Biopharma processing applications such as sight windows and quick-connects
Based on biocompatibility testing as defined by ISO 10993, Veradel® HC A-301 PESU demonstrates no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity. The material is expected to pass USP Class VI testing that is currently underway. These well-documented compliance records along with FDA Master Access File (MAF) support can facilitate the design and regulatory application process for medical device OEMs, thereby accelerating time to market.
Veradel® HC A-301 PESU helps balance Solvay’s portfolio of transparent, sulfone-based healthcare polymers, which have a long history of proven performance in advanced healthcare applications. Radel® polyphenylsulfone (PPSU) is a super-tough, transparent polymer that can withstand more than 1,000 cycles of steam sterilization without significant loss of properties.
Veradel® HC A-301 PESU offers heat resistance that is on par with Radel® PPSU. The material’s high flow rate makes it particularly suited for injection molding thin-walled parts and components with complex geometries. Its stiffness is the highest of all medical-grade sulfone polymers.
Udel® polysulfone (PSU) is a tough, high-strength transparent polymer that offers higher heat resistance and better hydrolytic stability than polycarbonate.
Alternative to PEI
Veradel® HC A-301 PESU exhibits properties similar to those of polyetherimide (PEI) for strength, stiffness, transparency, dimensional stability, and inherent flame resistance as well as compatibility with steam sterilization and chemical sterilants.
Comparison of transparent polymers
Download the Veradel® HC PESU Starter Kit
Get started with the industry’s first polyethersulfone with ISO 10993 biocompatibility and FDA Master Access File. Starter Kit includes:
- Product overview & technical data
- Comparison to other transparent polymers
- Design & processing guidelines
- Team dossier with global contacts.
Specialty Polymers for Medical Equipment
With over 25 years of experience as a leading materials supplier to the healthcare industry, Solvay provides the reliability, experience and innovation that medical device manufacturers expect from their partners.
Our dedicated healthcare team provides the product development, technical and regulatory support you need to grow your business globally.
Medical grade high-performance polymers
For limited exposure applications having less than 24 hours contact with bodily fluids and tissue
Today’s broad range of medical equipment requires different performance requirements that benefit from our many different polymers.
Tailored levels of chemical resistance
High stiffness and impact strength
ISO 10993:1 biocompatibility testing
Excellent surface finish
Transparent, opaque and gamma-stabilized colors
FDA Master Access Files (MAF) available
For applications having no contact with bodily fluids and tissues
OEMs can also benefit from the proven performance of our products used in diverse end-use applications including automotive, smart devices, electrical/electronics, and the chemical processing industry.
- Wide-ranging combinations of chemical, thermal and mechanical properties
- Superior surface aesthetics
- Metal-like stiffness
- Excellent electrical properties
- Flame retardancy (UL 94-V0)
Global technical and regulatory support
Solvay can be an added resource to your design and engineering team. We can provide the product development and technical and regulatory support you need to grow our business globally.
- Material recommendations
- Designing with plastics
- Moldflow® process modeling
- Finite element analysis
- Fabrication and assembly techniques
- Product testing and failure analysis
- Global regulatory submission assistance
- On-site materials training
- On-site processing support
Solvay’s healthcare plastics cover the gamut of sterilization technologies. Reusable devices are chemically washed and disinfected prior to any sterilization procedure. Those that are steam sterilized may be exposed to other chemicals, such as morpholine, which are often used in central steam sterilization systems to inhibit corrosion in the lines. For this reason, manufacturers should check performance under conditions that best simulate the intended use of the fabricated part in order to assess their cumulative effect on the material.
Compatibility with sterilization methods
|Radel® PPSU||Veradel® HC PESU||Udel® PSU||Ixef® PARA||AvaSpire® PAEK||KetaSpire® PEEK|
|Steam 18 minutes at 134°C|
|Ethylene Oxide Gas 100 cycles||✓||✓||✓||✓||✓||✓|
|Vaporized Hydrogen Peroxide 200 cycles||✓||✓||✓||✓||✓|
|High-Energy Gamma Radiation 40kGy||✓||✓(1)||✓||✓||✓||✓|
Contact your Solvay representative for information specific to Solviva® Biomaterials
(1) Veradel® HC PESU is compatible with high-energy gamma radiation but there is a drop in ductility.
Cleaning & Disinfection
Compatibility with cleaning agents and disinfectants is an important consideration when selecting materials for healthcare applications. Chemical resistance varies considerably among plastics and is largely dependent on molecular structure. Other influential factors include:
- Type of reagent
- Reagent concentration
- Exposure time
- Stress on fabricated part
Stress can be caused by an external load applied during use or by a residual internal stress in the molded part due to processing. Residual stress can be minimized by adjusting processing conditions. It’s important to be familiar with a material’s performance under unstressed and stressed conditions as some reagents having no effect on unstressed plastic can cause cracking when stressed.
The table below gives a general indication of the compatibility of our medical grade plastics with commonly used hospital disinfectants. Because performance and design criteria are application specific, manufacturers should check performance under conditions that best simulate the intended use of the fabricated part. This includes cleaning and disinfecting followed by sterilization in order to assess their cumulative effects on the material.
Compatibility with hospital disinfectants
|Radel® PPSU||Veradel® PESU||Udel® PSU||Ixef® PARA||AvaSpire® PAEK||KetaSpire® PEEK|
|Bleach Solutions, 10%||Excellent||Excellent||Excellent||Excellent||Excellent||Excellent|
|Lysetol® FF||Excellent||Good||Good||Not Tested||Excellent||Excellent|
|Hydrogen Peroxide, 3%||Excellent||Excellent||Excellent||Excellent||Excellent||Excellent|
|Isopropyl Alcohol, 70%||Excellent||Good||Good||Excellent||Excellent||Excellent|
|Puristeril Plus®||Excellent||Excellent||Excellent||Not Tested||Excellent||Excellent|
|Sporotal® 100||Excellent||Good||Good||Not Tested||Excellent||Excellent|
Customize your Look with Color
Set yourself apart from the competition by using color to create a fresh, exciting look for your products. Colors can also provide a quick visual reference for differentiating sizes.
Where transparency is important, consider Udel® PSU and Radel® PPSU resins, which in their natural state have a near water-white and light amber color respectively. They are available in a range of vibrant transparent colors that deliver a clear advantage over metal without compromising performance.
Solvay also offers a wide range of opaque colors for several of its medical grade plastics. Opaque and transparent Radel® PPSU colors and Ixef® PARA gamma stabilized colors are supported by FDA Master Access Files (MAF) and demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity. Custom colors available through partners.
|Veradel® HC PESU||✓|
(1) Gamma stabilized colors available
Single Use Instruments
Reduce Weight and Cost with Ixef® PARA
Ixef® GS-1022 is a 50% glass fiber reinforced polyarylamide (PARA) compound that uniquely combines high stiffness with an ultra-smooth finish that’s on par with painted metal.
It can be sterilized using high-energy gamma radiation without any significant change in appearance or loss of mechanical properties. These features make it well-suited for replacing metal in single-use instruments, thereby eliminating central service costs associated with the sterilization of reusable instruments.
Mechanical Properties vs. Metals
Tensile Strength, ISO 527 test method
Ixef® GS resins demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity, based on biocompatibility testing as defined by ISO 10993:1
The Look You Want. The Performance You Need.
Ixef® gamma-stabilized colors give healthcare professionals a quick visual reference for differentiating instrument sizes and present OEMs with unique branding opportunities.
Ixef® Gamma-Stabilized Colors for Healthcare
Pantone Matching System (PMS)
Typical lot color chips were matched to the Pantone® Matching System (PMS) formula guide on solid coated stock based on a visual assessment. The colors shown here are a representation of the color after exposure to 40 kGy gamma radiation and should be used only as a guide.
Color Change after Sterilization
A slight shift in color can be expected between the Ixef® GF-1022 resin and the molded part that has been exposed to gamma radiation.
Color change after gamma radiation
Properties after Sterilization
High-energy gamma radiation is most commonly used to sterilize bulk quantities of single-use healthcare instruments and devices. Dosage levels typically range from 20 to 40 kilograys (kGy) or 2 to 4 Megarads (Mrad).
Ixef GS grades exposed to these dosage levels retain their mechanical properties and exhibit significantly less color change than standard Ixef compounds.
Tensile properties after gamma radiation sterilization
Sterilization Cases and Trays
Impact Strength, Steam Resistance and Transparency
Radel® polyphenylsulfone (PPSU) is an incredibly tough, transparent plastic that can withstand more than 1,000 cycles of steam sterilization without any significant loss of properties. This makes it an excellent choice for cases, trays and other reusable medical devices.
PPSU delivers higher impact strength than polycarbonate (PC) and polyetherimide (PEI) and retains its toughness and strength over time. It also offers superior chemical resistance, making it highly resistant to commonly used cleaners and disinfectants over a broad temperature range.
- High heat resistance
- Superior impact strength
- Withstands over 1,000 autoclave cycles
- Excellent chemical resistance
- ISO 10993:1
- Transparent and opaque
- Colors available
Virtually Unlimited Steam Sterilizability
Steam autoclaving is the primary sterilization method used for cases and trays. Temperatures typically range between 121°C to 134°C (250°F to 273°F) with exposure times of 15 to 30 minutes.
Radel PPSU is unique among amorphous thermoplastics in its ability to withstand more than 1,000 cycles of steam sterilization without any significant loss of properties. Its toughness and strength are retained over time, unlike polycarbonate (PC) and polyetherimide (PEI) which exhibit a significant loss of impact strength and becomes brittle.
Retention of impact strength
Cleaning & Disinfection
Radel PPSU is highly resistant to song solutions of aqueous caustic solutions like sodium hydroxide, which has become one of the preferred methods for sterilization against Creutzfeldt-Jakob disease.
Ingredients are often added to cleaners and disinfectants to improve surface wetting and reduce evaporation. Our experience has shown that these chemicals can have a more detrimental affect on plastics than cleaners and disinfectants by themselves. This is primarily due to improper dilution or insufficient rinsing. Be sure to follow the manufacturer’s instructions to optimize the performance of the plastic.
|General Indication of Chemical Resistance||Radel®
|Bleach Solutions, 10%||Excellent||Good|
|Hydrogen Peroxide, 3%||Excellent||Good|
|Isopropyl Alcohol, 70%||Excellent||Good|
Customize Your Look with Color
Get the look you want and the performance you need. With Radel PPSU opaque and transparent colors, it’s easy to set yourself apart from the competition.
Specialty Polymers for Reusable Devices
Radel® PPSU (polyphenylsulfone) is an incredibly tough, transparent plastic that can withstand more than 1,000 cycles of steam sterilization without any significant loss of properties. PPSU exhibits higher impact strength than polycarbonate (PC) and polyetherimide (PEI) and retains its toughness and strength over time. Its superior chemical resistance makes it highly resistant to commonly used cleaners and disinfectants over a broad temperature range. Opaque and transparent colors as well as with glass fiber reinforced grades are available.
Veradel® HC PESU (polyethersulfone) is a durable, transparent polymer with heat resistance on par with Radel® PPSU. The material’s high flow rate makes it particularly suited for injection molding thin-walled parts and components with complex geometries. Its stiffness is the highest of all medical-grade sulfone polymers.
Udel® PSU (polysulfone) is a rigid, high-strength, semi-tough, transparent plastic that offers higher heat resistance and better hydrolytic stability than polycarbonate (PC). PSU retains its good mechanical properties when exposed to oxidizing agents, steam and other sterilization techniques. Opaque and transparent colors as well as glass fiber reinforced grades are available.
Ixef® PARA (polyarylamide) uniquely combines high stiffness with an ultra-smooth finish that’s on par with painted metal. Gamma-stabilized colors can be sterilized using gamma radiation without any significant change in appearance or loss of mechanical properties.
AvaSpire® PAEK (polyaryletherketone) is a versatile family of proprietary formulations tailored to provide new and unique combinations of performance and value. AV-600 Series products deliver excellent chemical resistance, good impact strength and can withstand more than a 1000 cycles of steam sterilization. Glass-fiber and carbon-fiber reinforced grades are available.
KetaSpire® PEEK (polyetheretherketone) is one of the most chemically resistant plastics available and offers excellent strength, stiffness and fatigue resistance. PEEK can be used continuously in hot water or steam without significant loss in physical properties. Glass-fiber and carbon-fiber reinforced grades are available.
Based on biocompatibility testing as defined by ISO 10993:1, our healthcare plastics demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity. They can be sterilized using all conventional sterilization methods, including steam, ethylene oxide, vaporized hydrogen peroxide and gamma radiation.
Guidelines for using Solvay Specialty Polymers in Medical Applications
Only products of Solvay Specialty Polymers USA, LLC designated as part of the Solviva® family of biomaterials may be considered as candidates for medical applications implanted in the human body and devices that are in contact with body fluids or tissues greater than 24 hours.
Considerations for Use of Solvay Products
Solvay has not performed clinical medical studies of the use of these medical grade and products. Moreover, Solvay has neither sought, nor received, approval from the Food and Drug Administration (FDA) for their use in implants in the human body or in applications in which there is contact with body fluids or tissues.
The suitability of these Solviva® grade products in a given end-use environment is dependent upon various conditions including, without limitation, chemical compatibility, temperature, part design, sterilization method, residual stresses, and external loads. It is the sole responsibility of the manufacturer of the final product, and not Solvay, to determine the suitability (including biocompatibility) of all raw materials and components, including any Solvay product, in order to ensure that the final product:
- is biocompatible and otherwise safe for its end use,
- performs or functions as intended, and
- complies with all FDA and other regulatory requirements.
It also is the sole responsibility of the manufacturer of the final end use product to conduct all necessary tests and inspections and to evaluate the final product under actual end-use requirements and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks.
Any decision regarding the appropriateness of a particular medical product in a particular clinical application should be based on the judgment of the manufacturer, seller, the FDA, and the treating physician. Do not rely upon Solvay. Solvay cannot weigh the benefits against the risks of a medical device and cannot offer a medical judgment on the safety or efficacy of the use of a Solvay product in a medical application.
The sterilization method and the number of sterilization cycles a medical device can withstand will vary depending upon type/grade of product, part design, processing parameters, sterilization temperature, and chemical environment. Therefore, the manufacturer of the end use final product must evaluate each device to determine the sterilization method and the number of permissible sterilization cycles appropriate for actual end use requirements and must adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks.
Solvay may contractually agree to provide existing test data and other information about its products or to perform new testing of the products. Such information is to be provided, and such services are to be performed, only pursuant to a written agreement that requires the manufacturer of the end use final product to accept full responsibility for defining the scope of testing and determining the adequacy and appropriateness of the testing for the end use. Such data and information are only preliminary and are not meant to assure the biocompatibility or suitability for use of these products as actually used in the final end use product and do not relieve the manufacturer of its responsibility to properly evaluate its final end-use product under actual end use requirements, nor does it relieve the manufacturer of any of its other responsibilities described in these Guidelines.
Re-Use of Medical Devices
Solvay does not warrant or represent that single-use medical devices made from a Solvay medical grade product are suitable for multiple uses. If the medical device is reprocessed and/or labeled for multiple uses, it is the responsibility of the reprocessor and/or manufacturer to determine the appropriate number of permissible uses by evaluating the device under actual sterilization, cleaning, and end-use conditions and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks.
FDA Master Files
If the FDA requires proprietary information about any Solvay Product as part of the 510(k) clearance or premarket application (PMA) approval process for the manufacturer's end-use final product, Solvay may establish a Drug or Device Master File and grant a right of reference to it, in order to allow FDA to review such information without disclosing Solvay's proprietary information to the manufacturer. An authorization to reference a Master File shall only be established pursuant to a written agreement with manufacturer.
Risk of Failure
There is a risk of failure and adverse consequences with all medical devices, including devices implanted in the human body and devices that are in contact with body fluids or tissues.
Disclaimer of Warranty
SOLVAY MAKES NO REPRESENTATION, PROMISE, EXPRESS WARRANTY OR IMPLIED WARRANTY (INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY USE AS MAY BE CONTEMPLATED) CONCERNING THE SUITABILITY OF ANY SOLVAY PRODUCT FOR USE IN MEDICAL APPLICATIONS, INCLUDING AN IMPLANT IN THE HUMAN BODY OR IN APPLICATIONS IN WHICH THERE IS CONTACT WITH BODY FLUIDS OR TISSUES. NO SOLVAY REPRESENTATIVE HAS THE AUTHORITY TO MAKE ANY ORAL REPRESENTATION THAT CONFLICTS WITH ANY PORTION OF THESE GUIDELINES.
Responsibility to Forward These Guidelines
If the purchaser of any Solvay products is not the manufacturer of the final end use product, it is the responsibility of the purchaser to forward these Guidelines to such manufacturer.