The existing array of Zillion Black single-use instruments (SUIs) are moulded from a high-stiffness, medical-grade Ixef GS-1022 GY51 gamma-stabilised 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, sterilised 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 at Bastos 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 moulded using Ixef PARA biocompatible resins. Bastos Viegas is unique in that it designs and manufactures in-house its injection moulding tools using advanced predictive modelling and 3D printing prototyping to fully optimise 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, sensitisation, 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.”