Solvay’s Ixef® PARA enables Zillion Black® single-use instruments
The existing array of Zillion Black® single-use instruments (SUIs) are molded from a high-stiffness, medical-grade Ixef® GS-1022 GY51 gamma-stabilized polyarylamide (PARA) resin and includes curettes, a wide variety of forceps, needle holders, and skin staple removers. The European-made Zillion Black® SUIs are manufactured under strict clean room conditions, sterilized in-house using ethylene oxide (EtO), and are EU medical device CE Class IIa certified, under an EN ISO 13485-2016 registered quality system.
“Hospitals and healthcare practices are now, more than ever, in need of ready-to-use ambulatory and operating theatre instruments that offer optimal mechanical and ergonomic properties with minimum handling costs,” said Luis Guimarães, CEO atBastos Viegas. “Solvay’s Ixef® PARA provides rigidity, dimensional stability and metal-like strength, which are essential to the performance of our Zillion Black® single-use instruments.”
Currently, Portugal-based Bastos Viegas is extending the product line to include up to one hundred SUIs that replace stainless steel instruments, all to be molded using Ixef® PARA biocompatible resins. Bastos Viegas is unique in that it designs and manufactures in-house its injection molding tools using advanced predictive modelling and 3D printing prototyping to fully optimize the instruments and appropriate tooling.
In addition to superior strength and stiffness, Ixef® PARA offers a highly aesthetic surface finish. This high-performance polyamide can withstand high-energy gamma radiation without significant change in appearance and physical properties. Ixef® PARA resins demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity, based on biocompatibility testing as defined by ISO 10993. Solvay offers these materials for healthcare applications that require limited exposure (less than 24 hours) to bodily fluids and tissue.
“The on-going collaboration between Solvay and Bastos Viegas demonstrates the reliability, product development, and technical and regulatory support that medical device manufacturers expect from their partners,” said Jeff Hrivnak, Global Business Manager for Healthcare at Solvay’s Specialty Polymers global business unit. “We will continue to leverage our experience as a leading materials supplier to the healthcare industry as Bastos Viegas progresses with the development and further diversification of its product range to deliver greater value to their customers.”
® Ixef is a registered trademark of Solvay.
® Zillion Black is a registered trademark of Bastos Viegas.
Bastos Viegas S.A. is a modern and efficient production unit based in Penafiel, Portugal and currently employs around 360 associates. Bastos Viegas has a very wide product range and a quality standard recognized internationally and a firm commitment to work in close co-operation with customers and official distributors, in Portugal and in export markets. The company produces varied types of surgical sets from small ambulatory surgery to surgical draping sets, catheterization, anaesthesia, as well as surgical sets for specific operations. The company’s objective is to maintain and develop the concept of offering products of consistent high-quality made in Europe. Bastos Viegas is certified EN ISO 13485:2016. All products considered Medical Devices are registered and certified for the use bearing the CE mark. More information at www.bastosviegas.com
Solvay is an advanced materials and specialty chemicals company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers worldwide in many diverse end markets. Its products are used in planes, cars, batteries, smart and medical devices, as well as in mineral and oil and gas extraction, enhancing efficiency and sustainability. Its lightweighting materials promote cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 27,000 employees in 62 countries. Net sales were €10.3 billion in 2018, with 90% from activities where Solvay ranks among the world's top 3 leaders, resulting in an EBITDA margin of 22%. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris Bloomberg: SOLB.BB - Reuters: SOLB.BR), and in the United States its shares (SOLVY) are traded through a level-1 ADR program. \Financial figures take into account the planned divestment of Polyamides.
Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, ultra-high performance aromatic polymers, and high‑barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil & Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.