Tempalux® medical grade PEI (polyetherimide)

Westlake Plastics manufactures medical grade polymer stock shapes in rods and sheets for orthopaedic trial parts and instruments, dental applications and other surgical tools and accessories requiring medical grade standards and biocompatibility. Within its range of medical grade polymers, Westlake offers: - Polycarbonate (PC) gamma sterilized under its Zelux® GS brand name - Polyetherimid (PEI) under its Tempalux® brand name - Polypropylen (PP) under its Propylux® brand name - Polyphenylsulfon (PPSU) under the Radel® brand name - Ultra High-Molecular Weight Polethylen (UHMW-PE) under its Lennite® brand name These polymers can be used for various medical and surgical tools, knee / hip / shoulder trial parts for orthopaedic implant kits and various other medical grade applications (sterilizable cases and containers) requiring high biocompatibility specifications (USP Class VI and ISO10993).

PROPYLUX® HS products deliver the required attributes for orthopedic applications including biocompatibility, chemical resistance and dimensional stability. Launched in 2004 by Westlake Plastics Europe, PROPYLUX® HS has gained wide acceptance by orthopaedic device manufacturers in Europe. At a similar price point as Pomalux, PROPYLUX® HS offers superior dimensional stability performance when processed through repeated 134°C Prion autoclaving cycles.The material also provides excellent chemical resistance to disinfecting and cleaning solutions and exhibits a very good balance of strength, toughness and ductility. As such, PROPYLUX® HS is well suited for use in applications including trial heads and cups for hip implants, knee provisional trials and impactor applications. The PROPYLUX® HS product line consists of 15 colors and 13 diameters. All colored materials are made with FDA compliant ingredients and the shaped rods have been tested and comply with key parts of ISO 10993.

Medical grade Zelux® GS polycarbonate (PC) is produced from resin formulated to meet the stringent performance characteristics and requirements of the healthcare industry. Suitable for EtO gas and limited autoclaving sterilization, the resin also has proprietary color enhancement technology to reduce color shift caused by gamma radiation. It can be used for various medical applications such as surgical equipment, instrument components, housings and covers, single use surgical devices. Our Zelux GS material is available in rods or sheets. Other engineering window grade polycarbonate is also available.

With the new tightening procedures for cleaning and disinfecting implant ancillaries, PPSU offers an interesting solution guaranteeing a longer life cycle for products. Though it costs usually more than other medical grade polymers (POM, PP), it can nevertheless prove to be more economical in the long term due to its durability. This is especially true for complex designs which are expensive to machine. PPSU does not have any problems with the cleaning & pre-disinfection products. Our material is lot controlled, serialized and is delivered with a certificate of conformance. Coloured resin has been tested under ISO10993/5/10/11/18. The material is not for permanent implantation. PPSU behaves very well after a large number of sterilisation cycles in an autoclave at 134°C/273°F, it can be sterilized through other methods (ETO; gamma, plasma, dry heat). it is polishable for a perfect finish.