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GE Advanced Materials : 06 July, 2004  (New Product)
The newest polycarbonate-based resins for healthcare offer resistance to lipids and lower colour shift after gamma sterilisation.
GE Advanced Materials continues to expand its family of high-performance healthcare polycarbonate (PC) products to meet the industry’s rapidly changing end-use requirements and to improve moulding options. Three new Lexan resins are introduced today, including a gamma-stabilised grade that combines improved resistance to lipids with multiple-cycle autoclave sterilisation capability; a gamma-stabilised grade that offers a mid-range melt-flow index (MFI); and a clear, high-heat PC for repeated autoclave use. All of the new products are available globally.

The first of the new GE materials is Lexan HPS7 resin, a lipid-resistant polycarbonate also stabilized for exposure to gamma (and electron (e-) beam) irradiation that shows no statistically significant change in physical properties after gamma sterilisation. Importantly, this material demonstrates two new capabilities:

1. Improved lipid resistance through retention of tensile elongation at typical three- to four-day exposure, with data indicating improvement even out to six days; and

2. Superior hydrolytic stability and excellent retention of impact strength after multiple autoclave cycles. By contrast, most competitive lipid-resistant PCs cannot typically withstand multiple cycles.

New Lexan HPS7 resin offers healthcare OEMs lipid resistance with gamma radiation and multiple autoclave cycle capabilities in one product. It is ISO 10993 biocompatible* and FDA-compliant for food-contact applications. The new product uses a proprietary non-brominated formulation to achieve gamma stability and has an MFI of 5g/10 minutes at 300C/1.2kg. Due to its excellent lipid, gamma, and autoclave performance, this new grade can be used in healthcare applications for the blood-care, surgical support equipment, and fluid-delivery segments. Potential uses include blood dialyser components, stopcocks, luers, and Y-sites.

GE also introduced today Lexan HPS4 resin, a gamma-stabilised material engineered for an MFI of 10, further expanding the flow options for GE’s gamma-resistant portfolio of materials. With the addition of this new product, the company now offers gamma-stabilized Lexan resin grades with MFIs of 5, 7, 10, 17.5, and 25, giving processors greater manufacturing flexibility. Like all of GE’s gamma-stabilised PCs, this new material shows no significant change in physical properties after exposure. This product does not use bromine, an ingredient often restricted in order to meet growing eco-label requirements.

Lexan HPS4 resin also demonstrates excellent hydrolytic stability, is ISO 10993 biocompatible* and is FDA food-contact compliant. It is designed to meet certain blood-care, surgical instrument, fluid delivery, and enclosure/housing application requirements specific to the healthcare industry. Potential applications include blood filters, blood bowls, fluid-connection devices, syringe components, housings requiring sterilisation, and surgical instruments.

Rounding out GE Advanced Materials’ newest healthcare product offering is Lexan 4404 resin, a clear, high-heat polycarbonate designed for use in devices exposed to multiple autoclave cycles, at temperatures up to 134 C. Similar to the other products introduced today, Lexan 4404 resin is also ISO 10993 biocompatible* and is FDA food-contact compliant. It is an excellent candidate for applications that may be exposed to up to 10 autoclave cycles at 134C and offers improved dimensional stability over most common PC resins. Accordingly, Lexan 4404 resin is a potential fit for a variety of surgical instruments and healthcare support equipment, along with certain bio-pharmaceutical applications, where the use of autoclave sterilisation is growing.

“With the launch of these products and with additional technologies in the pipeline, GE Advanced Materials’ focus on supporting the healthcare industry is clearly evident,” says Clare Frissora, market director, Healthcare, GE Advanced Materials. “Healthcare continues to evolve with global industry trends and drivers, creating a terrific environment for the use of our healthcare products and the benefits they can provide.”

In support of her statement, Frissora cited several key trends on which GE Advanced Materials is capitalizing to fuel the company’s growth in healthcare. These include:

• The increased use of lipids to carry drugs, necessitating delivery systems with greater resistance to lipids, coupled with longer-duration treatment environments;

• The growing need to enable productivity through the use of varying sterilization techniques for disposable and non-disposable applications, leading to the increased call for multiple-technique sterilization grades – for radiation (gamma and e-beam), autoclave, and traditional ethylene oxide (EtO) sterilization;

• Increased use of colour to meet both the functional and aesthetic needs of physicians and patients; and for OEMs and moulders, improved colour match and colour execution through moulded-in colour vs. masterbatch;

• Industry demand for greater biocompatibility to reduce interaction with bodily fluids and medications; and

• Growing industry concern over the need for enhanced security procedures to track and trace counterfeit healthcare products.

Underscoring GE’s continued focus on delivering innovative new products to the healthcare industry are two soon-to-be-announced resins, both available from the company for sampling now:

• A new Lexan resin grade offering improved post-gamma irradiation colour stability through use of an entirely new, non-brominated stabilisation technology; and

• A breakthrough Lexan resin technology for applications where combinations of increased flow, higher ductility, improved processability, and multiple-cycle autoclave sterilisations are required, but cannot be met by traditional polycarbonate grades.

Frissora adds that the global nature of healthcare is also creating an entirely new set of customer demands and that GE Advanced Materials is uniquely positioned with world-class products and services to assist customers in their global initiatives. “Our dedicated healthcare industry team of market and technical specialists is focused 100 percent on our healthcare customers,” Frissora said, concluding, “They are the reason we exist.”
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