K 2007 Trade press conference
July 3 and 4, 2007 in Frankenthal, Germany
Staying power as a basis for business
New types of plastic with a service package for medical applications
Presentation by Dr. Axel Gottschalk,
Business Management Styrenic Plastic Specialties,
BASF Aktiengesellschaft, Ludwigshafen, Germany
The market for medical technology, where all is about human health, is setting highest standards for product safety. Strict regulations and test procedures, time-consuming and cost-intensive approval processes are the consequences for all who are involved. On the other hand this market offers opportunities for product differentiation and a growth above average. In this environment, BASF is further extending its range of plastic specialties particularly tailored to the needs of this target market. New entries in 2007 include Terlux® 2812 HD from the family of styrenic copolymers together with two copolymeric polyacetals bearing the name Ultraform® PRO. Work is currently in progress on a glass-fibre reinforced Terluran®.
The new styrenic copolymers: more free-flowing and more stable
The new product in the HD family, Terlux® 2812 HD, is a material which usefully complements the existing range in the field of medical technology. HD stands for Healthcare & Diagnostics. The transparent MABS, Terlux 2812 HD (MABS here being the abbreviation for the monomers methyl methacrylate, acrylonitrile, butadiene and styrene), has a higher melt volume flow rate (MVR = 8 cm3/10 min) than the previously introduced Terlux 2802 HD. The distinctly more free-flowing material can be more easily processed, in multi-cavity moulds for example, and now allows the economically efficient production of particularly complex transparent components. A glass-fibre reinforced Terluran® for these applications is currently being developed. Due to the glass fibres this special ABS material will have an extraordinarily high modulus of elasticity rendering the material predestined for the production, for example, of particularly sturdy housings. In this way stable components having low wall thicknesses, as required for example in portable blood pressure or blood sugar test devices, could be produced. The high forces that this material can absorb will allow its use in functional components of applicators or piercing aids. Like the other grades already known for some time, the new Terlux and Terluran variants exhibit high resistance to chemicals and stress cracking.
Engineering plastic with a HD profile: Ultraform PRO
In contrast to the amorphous materials Terluran® and Terlux® used predominantly for housings, BASF’s two new POM grades (POM: polyoxymethylene; polyacetal) Ultraform® S2320 003 PRO and W2320 003 PRO are semicrystalline materials having high resistance to chemicals, and a high capacity of bearing mechanical loads as well as the good sliding friction properties for which POM is well known. This makes it particularly suitable for functional components such as valves, metering systems, springs, slide and gear elements and at the same time an ideal supplement for Terluran HD and Terlux HD. The suffix PRO (Profile Covered Raw Materials Only) results from the requirement to use only quite specific, strictly controlled starting materials, usually from a single manufacturer. The copolymeric polyacetals are sold with practically the same service package as the plastics in the HD family. The S and W grades with an MVR of 11 and 25 cm3/10min respectively differ in their flowability and molecular weight.
Comprehensive service package for medical technology
In the field of diagnosis and therapy trusting and reliable collaboration between the manufacturers of plastics and the producers of medical technology is particularly important. Accordingly, to accompany these new products BASF offers an extensive service package that is specially adapted to the requirements of this market. In addition to application-related support it comprises compatibility tests with special chemicals and tests in accordance with important international medical technology standards (e.g. US Pharmacopeia and ISO 10993-x) as well as the preparation of drug master files (DMFs). There is also the attested intention on the part of BASF to make no significant changes to the plastic formulations defined in the drug master file. The only exceptions arise when there are external pressures, e.g. changes in the legal framework.
Unchanging formulations
In addition to this, when changes to formulations do become necessary BASF guarantees to give customers at least 36 months advance notice. At the same time BASF’s own suppliers have to keep the formulations of their products constant. This service in the field of medical technology offers high benefits to customers. An unchanging formulation reduces the risk of costly new approvals for the medical device manufacturer. Furthermore, the long-term reliability of deliveries of the product ensures a high degree of certainty in planning and contributes to risk aversion in customers’ businesses. The tests carried out by BASF and the approvals associated with them also help simplify testing and approval procedures for users.
Modern medical technology can scarcely be imagined without the use of plastics. Although in comparison with the total plastics market the share of plastics used in medicine is very small, the growth rates are attractive. Market studies for ABS, e.g., accordingly estimate the market volume in Europe at about 20,000 metric tons per year. With the HD and PRO grades in its range of plastic products BASF is supporting its customers in this demanding growth market and gives them security for their investments.
Terlux, Terluran and PlasticsPlus
Terlux® and Terluran® HD belong to BASF’s family brand PlasticsPlus™. This product line comprises high-performance styrenic plastics, biodegradable materials and foams. Whenever exacting requirements have to be met, the experts and products of PlasticsPlus offer a high level of diversity, reliability, partnership and innovative solutions.
Photo: BASF, 2007
BASF has recently added three new products to its range of plastics for medical technology. The new Terlux® 2812 HD is a variant of the known Terlux 2802 HD, a transparent special ABS (MABS), with improved flow characteristics (HD stands for Healthcare & Diagnostics). Two representatives of the POM range, Ultraform® S2320 003 PRO and Ultraform W2320 003 PRO, are the first engineering plastics from BASF to which the extensive support service for medical technology products applies. A special glass-fibre reinforced Terluran® is currently being developed. BASF plans not to change the formulations of these products. But should this ever be necessary, customers will be informed at least 36 months in advance. What’s more, the numerous tests carried out for these products at BASF and the approvals associated with them ensure users a high level of planning certainty and minimise risks in their business.