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.
New AM Grades
Solvay Launches Additive Manufacturing Grades for Healthcare Industry
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