Lustran Polymers Products Meet Stringent Requirements of Medical Industry
Dec 19, 2006
Materials used in the production of medical devices must be screened for biocompatibility, ensuring that they do not cause adverse local or systemic effects in the body. The Lustran Polymers business unit of LANXESS has tested several resin grades according to the FDA-modified ISO 10993: Part 1 (including US Pharmacopeia Class VI) and can confirm compliance with this standard.
One such product, Lustran® ABS 348, is a resin of choice for many of the leading medical device producers in North America and overseas. Typical applications for this resin include piercing pins, roller clamps, filters and housings, diagnostic test kits and instrument handles.
Two medical devices using Lustran ABS 348 are helping to bring relief to sufferers of habitual snoring and chronic nasal obstruction. The SP 1010 and SP 1100 Somnoplasty® devices from Somnus Medical Technologies use an electrode to emit low-power, low-temperature radio frequency energy that shrinks tissue in the mouth and nose. The disposable portions of both devices use medical-grade Lustran ABS 348 resin. This material was selected because of its good moldability, texture, colorability, appearance and ability to withstand gamma radiation.
Dura Pharmaceuticals Inc. chose to use high-gloss Lustran ABS 348 in the mouthpiece of its durable, lightweight and compact Spiros® inhaler. In this application, the resin offers a good balance of physical properties and is easily processed due to good flow properties. The glossy surface formed by the Lustran resin reduces the chances of the powder medication sticking to the inside of the mouthpiece during use.
Surgical instruments from Guidant Corporation's Cardiac and Vascular Surgery Group use Lustran ABS 348 resin in multiple components, including the handle of the VasoView® 1 Balloon Dissection Cannula and the orbit handle, dissector handle and swivel cap of the VasoView Orbital Dissection Cannula. Guidant also makes a universal seal for surgical trocars made from Lustran ABS 348.
QuickScript® System automated prescription-filling machines from AutoMed Technologies Inc. contain hundreds of canisters and trays that were designed and manufactured as injection-molded parts using Lustran ABS 348. The material meets the durability requirements and offers a very good surface finish as molded.
Additional Lustran Polymers products that comply with the FDA-modified ISO 10993: Part 1 standard include Lustran ABS 248FC grades, which are designed for use in drug inhaler device components, and Lustran SAN 31, which is used in the manufacture of transparent components including disposable diagnostic devices, labware, rigid IV and fluid handling components.
About Lustran Polymers:
Lustran Polymers is one of the biggest suppliers in the sector. Our products are familiar in a wide variety of applications that touch our lives everyday. For example, our Lustran® ABS and SAN products are well recognized and effective in a range of applications such as appliances, house wares, medical devices, telecommunications, truck & bus, and automotives. Triax® (ABS-PA) alloys use proprietary technology to provide an attractive balance of mechanical and thermal properties for innovative applications in electronics, outdoor equipment, power tools, sports and automotive body components. Our Centrex® (ASA, AES and ASA-PC) blends have been proven for more than 20 years in the spa, lawn & garden, and recreational vehicle markets. Centrex® provides a protective cap for PVC construction materials, and Centrex® resins have also incorporated new developments specifically for the construction and marine industry.
The Lustran Polymers business unit is part of the LANXESS Engineering Plastics segment, which achieved sales of EUR 1.737 billion in the 2005 business year.
About LANXESS
LANXESS Corporation was formed when the Bayer Group combined most of its chemical businesses and large segments of its polymer activities. The company began operating as a legal entity in the United States on July 1, 2004. LANXESS Corporation is a member of the German LANXESS-Group that was spun-off from Bayer in January 2005.
The LANXESS-Group manufactures high-quality products in the areas of chemicals, synthetic rubber and plastics. The companies' portfolio comprises basic and fine chemicals, color pigments, plastics, synthetic rubber and rubber chemicals, leather, textile processing chemicals, material protection products and water treatment products.
In 2005, LANXESS Corporation employed about 1,900 persons in the United States.
This news release contains forward-looking statements based on current assumptions and forecasts made by LANXESS AG management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.