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Solvay Launches ISO 10993 Biocompatibility-certified PESU for Medical Devices

Published on 2016-02-10. Author : SpecialChem

ALPHARETTA, Ga. -- Solvay Specialty Polymers, among the leading global suppliers of high-performance materials, introduced Veradel® HC A-301 polyethersulfone (PESU). The medical-grade polymer retains transparency and stiffness at high temperatures and offers processing advantages over other commercial high-heat, transparent polymers.

Solvay Specialty Polymers
Fig. 1: Solvay Specialty Polymers

Solvay’s Veradel® HC A-301 PESU has been tested under ISO 10993 biocompatibility standards for cytotoxicity, irritation and acute systemic toxicity. It is the first PESU polymer for use in medical devices to offer a Master Access File (MAF) on record with the U.S. Food and Drug Administration (FDA). The material is expected to pass USP Class VI testing, making it an excellent candidate for use in biopharma processing applications. These well-documented compliance records can facilitate the design and regulatory application process for medical device OEMs, thereby accelerating product time to market.

Veradel® HC A-301 PESU complements Solvay’s portfolio of transparent, sulfone-based polymers, including Radel® polyphenylsulfone (PPSU) and Udel® polysulfone (PSU), which have a long history of proven performance in advanced healthcare applications. Solvay’s new healthcare-grade PESU offers heat resistance that is on par with Radel® PPSU; and its 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.

Veradel® HC A-301 PESU is a viable alternative to polyetherimide (PEI) as it exhibits properties similar to those of PEI for strength, transparency, dimensional stability, inherent flame resistance and compatibility with steam sterilization and chemical sterilants. Veradel® HC A-301 PESU’s lower inherent color and higher flow rate may prove advantageous in some applications.
Solvay Specialty Polymers Introduces Veradel® HC A-301 Polyethersulfone (PESU), a Transparent, Tough and Highly Processable Amorphous Polymer for Advanced Healthcare Applications
Fig. 2: Solvay Specialty Polymers Introduces Veradel® HC A-301 Polyethersulfone (PESU), a Transparent, Tough and Highly Processable Amorphous Polymer for Advanced Healthcare Applications

“The healthcare market’s continuing fast-paced growth has strained both the supply and performance limits of competitive polymer chemistries,” said Jeff Hrivnak, global business development manager for Healthcare at Solvay Specialty Polymers. “Yet Solvay remains ahead of the industry curve. With the introduction of Veradel® HC A-301 PESU, we can now offer customers more options for MAF-supported polymers for medical device applications.”

Target applications for Veradel® HC A-301 PESU include housings and internal structural components for medical diagnostic equipment, monitoring and filtration devices, and biopharma processing applications such as sight windows and quick-connects. The material is currently available worldwide for sampling in healthcare applications.

Solvay Specialty Polymers’ experience as a reliable materials supplier in the healthcare field spans more than 25 years. The company is a leading manufacturer of healthcare plastics, offering a broad range of high-performance, medical-grade plastics for orthopedics, sterilization cases and trays, medical and dental devices, as well as filtration media and housings for hemodialysis and water purification membranes. Solvay also offers a family of Solviva® Biomaterials for use in a range of implantable devices.

About Solvay


Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra-high performance polymers, high barrier polymers and cross-linked high-performance compounds – for use in aerospace, alternative energy, automotive, healthcare, membranes, oil and gas, packaging, plumbing, semiconductors, wire & cable, and other industries.

An international chemical and advanced materials company, Solvay assists its customers in innovating, developing and delivering high-value, sustainable products and solutions which consume less energy and reduce CO2 emissions, optimize the use of resources and improve the quality of life. Solvay serves diversified global end markets, including automotive and aerospace, consumer goods and healthcare, energy and environment, electricity and electronics, building and construction as well as industrial applications. Solvay is headquartered in Brussels with about 30,000 employees spread across 53 countries. In 2014, the company posted pro forma net sales of close to € 12 billion, 90% of which was generated from activities where it ranks among the world’s top 3 players. Solvay SA (SOLB.BE) is listed on Euronext in Brussels and Paris (Bloomberg: SOLB.BB - Reuters: SOLB.BR).

Source: Solvay

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