EMDT_European Medical Device Technology

European Medical Device Technology, Summer 2015

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marketplace In Focus 30 | Summer 2015 European Medical Device Technology emdt.co.uk Tubing and Extrusion Polymer additives Struktol Co. of America, a global supplier of polymer additives, offers the TR 063A, TR 044W and TR 077 additives for engineered plastics, which have been designed to optimise processing and performance capabilities for compounders, processors and end-users. The first additive is a lubricant and viscosity reducer for nylon 6 and nylon 6,6 compounds, the second offers viscosity reduction and good mould release characteristics for ordinary and highly filled polycarbonate resins and compounds, and the third provides enhanced metal release properties for processors of nylon 6 and 6,6. Struktol TR 063A can be added directly at the compounding stage or, by the pro- cessor, during part manufacturing via extrusion or injection moulding. Struktol Co. of America Stow, OH, USA +1 330 928 5188 www.struktol.com Balloon-forming machine BW-TEC AG offers the fully automated Model 1250 balloon-forming machine. Designed to produce a variety of plastic balloons via a stretch-blow-moulding process, this machine is equipped with a parison former that pulls extruded material from a spool and necks down the tube in preparation for the balloon formation process. The unit electrically preheats the tube and feeds it into a split mould, where the balloon is formed within seconds. Heating and cooling dies hold their temperature and move into position to heat or cool the thin balloon mould. The manufacturer makes equipment for use in the production of balloon catheters for percutaneous transluminal angioplasty and percutaneous transluminal coronary angioplasty, including machines for weld- ing, cutting, necking, moulding, drilling, testing and other operations. Available balloon formers are able to produce bal- loons up to 300 mm long. BW-TEC AG Höri, Switzerland +41 44 863 7070 www.bwtec.com Capillary tubing Polymicro Technologies VS (vision system) flexible fused-silica capillary tubing from Molex Elektronik GmbH features precise inner-diameter tolerances to provide repeatable gas and fluidic flow control in medical device applications. Drawn from high-purity synthetic fused-silica preforms, this high-performance tubing offers tolerances as fine as ±1 µm for inner diameters as large as 50 µm. These tight tolerances optimise dos- age precision, yield highly reproducible gas and fluid delivery rates, and minimise variance in system dead volumes in critical applications involving capillary tubing. The industry-standard outside-diameter dimen- sions of the capillary tubing in this line are designed for easy interfacing with existing connector technology. The tubing can be cut or cleaved to length, is rated for opera- tion at temperatures as high as 350°C, and can be customised to meet user specifica- tions. Molex Elektronik GmbH Ettlingen, Germany +49 7243 3350 www.molex.com Moulding and extrusion equipment To help medical plastics processors select, install, commission and start up white rooms and cleanrooms more quickly, the Conair Group introduces the MedLine range of auxiliary equipment units for the moulding and extrusion of medical devices. The offering comprises 170 items in all and includes equipment for conveying and storage, resin drying, blending, heat transfer and downstream extrusion. All of the products are based on proven designs and have been specially sized, configured, documented and supported for use in medical device manufacturing cleanrooms. Only mechanical equipment and materials compliant with the ISO 14644 standards for cleanrooms are used in construction. Depending on application requirements, machine surfaces may be powder-coated in RAL 9003 signal white or made from stainless steel. The manufacturer supplies all equipment with a quality and regulatory compliance package aligned with ISO and US FDA requirements. Machines are factory calibrated to meet regulatory requirements, labelled, and certified for one year. Documentation provided includes installation qualification forms ready to be filled out and filed, along with reporting forms for preventive maintenance procedures carried out for purposes of regulatory compliance. The forms are intended to reduce the paperwork processors typically must generate to validate compliance of their cleanroom facilities and processes. The Conair Group Cranberry Township, PA, USA +1 724 584 5500 www.conairgroup.com

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