Formulation constancy and much more: A new product joins the service package for medical technology
On February 1 of this year, BASF launched another plastic specialty for the field of medical technology. Terluran® HD-15 is an ABS (acrylonitrile butadiene styrene) that is being marketed with a service package tailor-made for the requirements of medical technology. This material belongs to the PlasticsPlus™ product line of the Styrene Plastics Operating Division. The abbreviation HD stands for “Health Care and Diagnostics”.
Improved chemical resistance
Thanks to its flow index of 15 ml/10 min, Terluran HD-15 is easy to process by injection molding. The new product surpasses conventional ABS particularly when it comes to its improved resistance to chemicals. Aside from this property, which is of utmost significance for manufacturers of technical medical products, Terluran HD also exhibits optimized toughness and rigidity values. Typical applications include the housings of inhalers.
Up until now, BASF had bundled its service package for medical technology with its transparent plastic Terlux® 2802 HD (MABS). Features of this package are long-term formulation constancy, product purity and a wide array of basic experiments on chemical compatibility. “The service package was well received by our MABS customers, so we have now expanded it to include our newly developed Terluran HD-15,” explains Dr. Axel Gottschalk, Business Manager for ABS specialties. This product is now commercially available.
Formulation constancy and statutory requirements
Before manufacturers of medical equipment receive approval for their products, they have to meet stringent national and international statutory requirements. The approvals associated with Terluran HD-15 – as was the case with the previously introduced Terlux 2802 HD – include conformity with the European Pharmacopoeia (EP 5th edition, Chapter 3.2.2) as well with the so-called Drug Master File (DMF), which facilitates obtaining approval in the United States.
An essential difference from a standard ABS also lies in the guarantee that customers will be informed at least 24 months in advance about any changes to the formulation that might become necessary. “We could not provide this assurance of formulation constancy for a standard ABS,” explains Dr. Gottschalk. Another component of the service package includes biocompatibility testing for the raw material in accordance with international standards as well as technical support for applications.
BASF has bundled a product line of specialty plastics comprising high-performance styrene plastics, biodegradable materials and foams under the umbrella of PlasticsPlus™. Whenever high requirements have to be met, our experts, working with the products of PlasticsPlus, can provide a great deal of diversity, reliability, partnership as well as innovative solutions.
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