Lustran Polymers Products Meet Stringent Requirements Of Medical Industry
Medical OEMs and specifiers rely on Lustran® ABS and SAN resins
Addyston, OH - – 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.
SOURCE: LANXESS Corporation