Solvay’s Ixef PARA for single-use instruments

Solvay’s Ixef PARA for single-use instruments

March 21, 2019

Solvay

https://www.solvay.com
Design Components Materials

The existing array of Bastos Viegas’ Zillion Black single-use instruments (SUIs) are molded from
Solvay’s Ixef GS-1022 GY51 a high-stiffness medical-grade gamma-stabilized polyarylamide (PARA)
resin and includes curettes, a wide variety of forceps, needle holders, and skin staple removers.
Photo courtesy of Solvay

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 from Solvay and includes curettes, a wide variety of forceps, needle holders, and skin staple removers. The European-made Zillion Black SUIs are manufactured under strict cleanroom 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.

Currently, Portugal-based Bastos Viegas is extending the product line to include up to 100 SUIs that replace stainless steel instruments, all to be molded using Ixef PARA biocompatible resins. Bastos Viegas designs and manufactures its injection molding tools in-house 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.