MEDICAL | MATERIALS
regulations and are aesthetically pleasing. A repre- sentative example is the manufacture of multicompo- nent applications that saves mounting time by combining a hard polymer with a soft-touch TPE using direct injection moulding (without bonding agents). The MGP-compliant TPE compounds that have been available in the market previously do not provide adhesion to polyamides and thus cannot be used for many sophisticated applications. The compounds of the new TPE series meet the
recently adopted VDI 2017 guideline that regulates the criteria for MGP-compliant materials – from basic requirements to formulation consistency and modification management. They comply with the Commission Regulation (EU) No. 10/2011 and the Code of Federal Regulations Title 21 (21CFR) of the US FDA. The new TPEs also meet the requirements for human compatibility in accordance with the specifications of the ISO 10993-5 and 10993-11 standards. All types can be sterilised using beta or gamma radiation, or ethylene oxide. They also comply RoHS and REACH regulations in the EU. Kraiburg TPE manufactures the materials
exclusively on specially approved production lines. Quality assurance extends through to full traceabil- ity of raw materials on the suppliers’ side. Types with a hardness range between 60 and 70 Shore A are currently available. The company says they provide smooth and velvety surfaces with a soft touch featuring good resistance to scratches, wear and sebum (lipids secreted to the skin’s surface). Trinseo has launched a range of wear-resistant, high lubricity PC resins highly suited to drug delivery applications. The company says the resins have been designed for drug delivery devices and surgical tools, which are growing in importance for
their convenience and cost saving potential. Part of Trinseo’s Calibre series, the new material platform provides a solution for the low friction movement of one material over another, extending product life and minimising noise without external lubri- cants. The company has also developed the Emerge 9000 product portfolio. This product range is used extensively in diagnostic equipment housings to resist the aggressive cleansers and disinfectants used by healthcare professionals to fight healthcare associated infections. Borealis and Borouge have launched a new service solution, Bormed InCompounds, which enables the customisation of compounds based on Bormed for use in an even wider range of targeted healthcare applications and products. Borealis says it collaborates with selected compounders to offer Bormed quality, reliability and conformance in compounds and masterbatches. Each collaborator must have a dedicated healthcare team composed of marketing and business development managers as well as application and regulatory experts; an established healthcare product brand; and ISO 13485-2016. At present, Bormed InCompounds involves close collaboration with long-standing and trusted Borealis partners Clariant, Melitek and Wittenburg.
Above: SABIC has introduced a new range of polycar- bonate copolymer resins featuring the chemical resistance needed to enhance the durability and resilience of medical devices and equipment housings
www.injectionworld.com
CLICK ON THE LINKS FOR MORE INFORMATION: �
www.rtpcompany.com �
www.fostercomp.com �
www.topas.com �
www.silicones.elkem.com �
www.teknorapex.com �
www.covestro.com �
www.evonik.com �
www.sabic.com �
www.solvay.com �
www.kraiburg-tpe.com �
www.trinseo.com �
www.borealisgroup.com �
www.borouge.com
January/February 2020 | INJECTION WORLD 45
Above: Kraiburg TPE has introduced VDI 2017-com- pliant Thermo- last M com- pounds for TPE/PA
composite applications
IMAGE: SABIC
IMAGE: KRAIBURG TPE
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