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Customized medical technology solutions

BASF is putting its best foot forward at the Compamed trade show in Dusseldorf, Germany, as a partner for the development of customized materials for medical devices.

The company will be exhibiting its extensive portfolio of Hygentic ® products and supporting services, the safe plasticizer Hexamoll ® DINCH and a variety of high-performance plastics for medial technology applications from November 16 through 18, 2011 at the Compamed trade show in Düsseldorf (booth 8bG21, hall 08b).

Hygentic® additives feature excellent antimicrobial effects. BASF cooperates with its customers to find solutions for medical device and equipment surfaces that durably prevent potentially hazardous microbial buildup. “Products enhanced with our additives support the measures of professional hospital hygiene,” explained Edgar Eichholz, Launch Manager Medical Device Materials. This minimizes the risk of medical devices contributing to the acquisition of infections.

Its broad product portfolio and its technical expertise enable BASF to offer formulations customized to meet specific demands. BASF's developers work together closely with customers in this process. BASF's medical devices team has technical capabilities to produce customized formulations and to incorporate them into a variety of materials, such as thermoplastics or silicones, at its technical center at Tarrytown, New York.

For manufacturers of medical devices and equipment the BASF team combines silver ions contained in a variety of substrates to meet the requirements of a given application. “This selective combination produces synergy effects that enhance the efficiency of the individual components,” Eichholz explained. In the formulations obtained in this way, the silver ions will act longer, for example, or faster. A dedicated microbiology team checks the various formulations obtained for antimicrobial effectiveness against relevant microorganisms, including mulitresistant pathogens like MRSA (methicillin-resistant Staphylococcus aureus).

BASF is also researching new generations of materials with novel surface effects that are of interest for medical devices and equipment and offers cooperation opportunities for medical device manufacturers.

On the occasion of the COMPAMED Forum Dr. Richard Thomas, member of the medical technology team of BASF in Tarrytown, USA, is going to give a speech on the topic “Anti-infective Surfaces in Medical Devices”.

High-performance plastics prove themselves valuable in medical technology

BASF's plastics portfolio identified by the suffix “PRO,” which has been geared specifically to meet the needs of the medical technology industry, meanwhile comprises two classes of materials: the Ultraform ® PRO range (POM: polyoxymethylene; polyacetal) and Ultradur ® B4520 PRO (PBT: polybutylene terephthalate). By way of customized individual product advantages, the tribological combination of plastic parts made of Ultraform ® PRO and Ultradur ® PRO translates into additional synergisms: for instance, insulin pens with excellent sliding friction properties can be produced with these materials. Here, Ultraform ® PRO accounts for low friction between the individual functional parts while Ultradur ® PRO, as the sliding member, reliably prevents annoying noises during use.

High-viscosity Ultraform ® PRO and first medical grade Ultradur ® PRO

Ultraform ® N2320 003 PRO is a new injection-molding grade with a higher viscosity being added to the range. Thanks to its high impact resistance and stiffness, this new Ultraform ® N grade is just right for the manufacture of highly stressed elements such as functional parts in insulin pens, atomizing devices or dry-powder inhalers.

The likewise new Ultraform ® H4320 PRO has been tailored specifically for processing by extrusion at high ejection speeds. It is highly viscous, even more impact-resistant while also being very stiff as well as strong and it displays good thermal stability. Its target applications are plug-in connectors, handles of surgical instruments and other components that are made from semi-finished parts.

First Ultradur ® PRO for medical technology

With its Ultradur ® B4520 PRO, BASF is launching its first PBT for injection-molded applications in medical technology. In the new Ultradur ® B4520 PRO, the well-known high dimensional stability of PBT, has been further improved by adding optimized shrinkage behavior, so that this product now meets the stricter requirements in terms of reproducible dimensional accuracy made on components intended for medical devices. Most importantly, this material can be easily printed on and sterilized with ionizing gamma radiation or ethylene oxide.

Ultrason ® high-performance plastic

With its stability at high temperatures and exceptional chemical resistance, Ultrason ® , too, is suitable for medical technology applications. What is more: it is transparent. In addition, most products from this range have been certified to the typical food contact and drinking water standards.

Comprehensive service package for medical technology

Along with its plastics from the “PRO” family (PRO: profile covered raw materials only) BASF offers a comprehensive service package that has been adapted specifically to the requirements of medical technology. Aside from support relating to applications technology, this package entails the explicit commitment that no changes will be made in the plastic formulation stored in the Drug Master File (DMF) at the FDA. All product grades of the PRO range have been shown to comply with the applicable international standards and tests for medical technology uses of plastics such as the EU, US and Japanese Pharmacopeias and DIN EN ISO 10993-5. Such tests are performed (on pellets) by independent third-party institutes.

Hexamoll ® DINCH: alternative plasticizer for medical device applications

BASF's Petrochemicals division presents its non-phthalate plasticizer Hexamoll ® DINCH for the first time at Compamed. This safe plasticizer has been developed specifically for sensitive applications with close human contact.

Due to its low migration rate and excellent toxicological profile, the alternative plasticizer offers maximum safety. It is used, for example, for enteral and parenteral nutrition and other medical applications like catheters and breathing masks. A number of studies have shown that Hexamoll ® DINCH is suitable for use in blood bags. It allows for a storage period of at least 42 days for red blood cells and 6 days for platelets, without any problems whatsoever. Excellent compatibility with blood is also demonstrated by its use in dialysis blood lines. On top soft PVC articles containing Hexamoll ® DINCH retain their technical performance even after sterilization. Hexamoll ® DINCH fulfills the requirements of various regulatory frameworks for medical devices in Europe and North America. Furthermore, it is approved for food contact applications in numerous countries.

Leading brand owners in the medical business, the toy industry and food packaging have upgraded to Hexamoll ® DINCH because of its versatility, supply security and traceability. BASF is committed to meet the growing demand and will double its current annual production capacity of 100,000 metric tons to 200,000 metric tons by 2013.

Dr. Silke Germer, toxicology specialist at BASF, will present the regulatory challenges for plasticizers in medical devices speaking at the COMPAMED forum in Hall 8a, at 11:00 a.m. on November 17.
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