Solvay Achieves ISO Certification for Solviva® Biomaterials
Solvay achieves ISO 13485:2003 certification for the quality system that governs the production of its Solviva® Biomaterials offered for use in implantable medical devices.
Solvay Advanced Polymers, LLC, announced today that it has achieved ISO 13485:2003 certification for the quality system that governs the production of its Solviva Biomaterials offered for use in implantable medical devices. The international quality standard facilitates harmonized medical device regulatory requirements for quality management systems applicable to medical devices and related services.
ISO 13485:2003 is a quality standard that specifies certain quality system requirements to ensure consistent manufacturing, according to Judy Melville, business manager, Solviva products. “This achievement demonstrates our commitment to the medical device industry,” said Melville. “It also reaffirms our position as a reliable supplier that is solidly focused on meeting the quality standards of our customers.” Melville noted that a key element of the ISO quality standard is the use of validation methods to ensure consistent high-quality manufacturing. Solvay Advanced Polymers produces its unique line of biomaterials – featuring exceptional strength, stiffness, and biocompatibility – at a dedicated manufacturing facility in Alpharetta, Ga.
The entire line of Solviva Biomaterials is manufactured in compliance with ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. The company’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in a lab accredited to the ISO 17025:2005 standard.
The Solviva Biomaterials line includes Zeniva® polyetheretherketone (PEEK), one of the most biostable plastics available with high strength and stiffness plus excellent toughness and fatigue resistance; Proniva® self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastics that offers exceptional biocompatibility and hardness; Veriva® polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Eviva® polysulfone (PSU), which offers practical toughness in a strong, transparent polymer.
Solviva Biomaterials can be sterilized via all conventional methods including gamma radiation, ethylene oxide, and steam. These products are available in resin for injection molding or extrusion, as well as stock shapes for machined components. Solvay Advanced Polymers is currently in active product trials with several medical device manufacturers using the broad range of Solviva biomaterials.
Solvay’s experience as a key materials supplier in the healthcare field spans more than 20 years. The company has been a leading manufacturer of high-performance plastics, offering its traditional range of materials for medical devices. More recently, Solvay has successfully introduced its line of Solviva Biomaterials for a range of implantable devices. The company is a full-service supplier, providing design, technical service, and application development support for the global healthcare market.