Medical Device Link.

EQUIPMENT UPDATE

Machining centre packs power into small footprint

A machining centre from Datron Technology Ltd (Milton Keynes, UK; www.datrongroup.com) is designed as an entry-level machine for applications as diverse as rapid prototyping, foiling and embossing dies, fascias, control panels, PCBs and precision engraving. Built with the company’s trademark granite table to offer high precision, stability and robustness, the Datron M75 system is equipped with a 1.2 kW spindle that is capable of operating up to speeds of 30,000 rpm. The same design principles have also been applied to the M75 with the 520 × 650 × 240 mm worktable within a small 1300-mm2 machine footprint. A 10-position self-tool changer with tool length sensor is also offered as standard.

An optional probe can be fitted at extra cost, depending on the purchaser’s requirements. In operation, the fast-acting probe will automatically swing down as programmed, without the need to clear the tool out of the way. A full tooling package is also available.

At high speeds, robustness and stability is vital during the cutting process and vibration can be problematic. The manufacturer has overcome this by not only incorporating a granite table into the M75 but also developing a unique matrix cone clamping system, which ensures that fixtures are located quickly and accurately every time. This provides reductions in set-up time as well as the flexibility to be able to take off one job and put another on if priorities require, with no loss of accuracy because of the location system. Cycle times are also appreciably shortened.

Providing powerful control and fast cutting capability over 6 axes, the M75 shows its versatility, for example, by being able to engrave over a curve, such as a pump housing or cylinder. It is quiet in operation and is equally efficient cutting ureol, CFRP or acrylics as well as stainless steel, aluminium, brass, copper and the harder metals.

Gas plasma system designed for lean manufacturing

The latest in a series of highly configurable high-throughput radio-frequency (RF) vacuum gas plasma systems features a universal architecture that suits it for lean medical manufacturing environments. Whether production circumstances call for high-speed automation, stand-alone processing, or cleanroom operation, the FlexTrak plasma treatment system from March Plasma Systems Inc. (Concord, CA, USA; www.marchplasma.com) is available for use in modifying the surface of medical device components through direct, downstream or ion-free plasma application. Gas plasma treatment is a fast, efficient method for cleaning, coating or modifying part surfaces, imparting to those surfaces improvements in bondability, lubricity, wettability, hydrophilicity, hydrophobicity or biocompatibility.

Easily integrated into various types of processing equipment, this system claims minimal floor space and allows front access to all serviceable components. It uses closed-loop plasma control to optimise the RF system and minimise tuning time; compensating for changes in vacuum pressure, temperature and lot size, it automatically recycles to a plasma-ready state. Intuitive software and a graphical interface facilitate touch screen programming, and the software platform offers Ethernet, Internet, and local-area network connectivity. Applications include catheter bonding, stent cleaning, sensor cleaning and functionalisation, PCB bond-pad cleaning and bonding of noncompatible materials.

Laser-machining systems satisfy 21 CFR Part 820

High-precision laser-based fabrication systems for producing medical devices, such as stents, intended for deployment in the United States are designed to facilitate conformance with requirements of the US FDA regulation codified in 21 CFR Part 820. T15 stent micromachining systems from Swiss Tec AG (Schaan, Liechtenstein; www.swisstecag.com) employ a fibre laser to cut small components with 1-µm precision and repeatability. The high-throughput systems are supplied with an integrated metrology and inspection system to monitor the accuracy of the stent outline at this level of precision on an industrial scale. In addition, the system’s statistical analysis capability supports the application of Six Sigma process control and thus the provision of quantitative process documentation in a well-established format.

With its introduction of picosecond lasers, the equipment manufacturer has been developing a precision-power percussion ablation system that optimises stent cutting such that the need for subsequent cleaning and electropolishing of the devices is minimal and rejection rates are low. This technology enhancement makes individual part marking of stents in accordance with 21 CFR 820 practical, because the marking will not be removed during the course of secondary stent processing.

Technology suited for energy-efficient metallising and coating

Nearly all materials can be metallised and coated energy-efficiently and without solvents through the use of a patented technology that works via a combination of cold active plasma and micro- or nanoparticles. Reinhausen Plasma GmbH (Regensburg, Germany; www.reinhausen-plasma.com) developed the nanopowder plasma deposition technology, called plasmadust for short, to allow environmentally friendly direct coating without chemicals, and to produce coatings free of volatile organic compounds. Owing to the low-temperature melting points of the coating powders, the coating process can be carried out at ambient pressures; thus, the technology consumes much less power than thermal injection processes require.

The use of cold active plasma sources additionally contributes to the system’s energy efficiency. Gas temperature does not exceed 70°C under atmospheric pressure. Thus, temperature-sensitive plastic, metal, glass, foil substrates and silicon disks and parts made from unusual material combinations can be processed by means of this system. Both continuous and structured coatings in a variety of nanopowders can be deposited in a layer as thin as 1 µm precisely and efficiently. Adhesion to two- and three-dimensional parts is very good. Processing speeds up to
150 m/min are possible.

Laser welding systems offer operational flexibility

A range of laser welding systems available from the medical product manufacturing equipment supplier Rofin-Baasel UK Ltd (Daventry, Northants, UK; www.rofin.co.uk) includes the ergonomically designed and fully integrated StarWeld Select system, which is pictured here. This flexible welding system incorporates four high-precision axes that can be either controlled manually via a joystick or operated automatically under full computer numerical control. Key elements of the unit include a flow-controlled exhaust system with HEPA filters and a closed-loop cooling system that enables continuous operation from a standard single-phase power supply without the need for external accessories. Designed to offer the user as much automation as is desired without adding much complexity, the system makes parameter adjustment by means of the multifunction joystick or the large colour touch screen easy.

In addition to laser welding systems such as this, the manufacturer offers a range of laser sources to meet the varied requirements of both end-users and system integrators. The StarPulse laser, for example, readily integrated into production lines and available with an average laser power of 40 to 500 W, produces beam output offering the level of quality and consistency of penetration necessary for high-precision, fine-scale miniature medical device welding applications.

Blast cabinets are engineered for medical applications

A range of stainless steel blast cabinets has been specially engineered for medical product manufacturers and laboratories where the introduction of ferrous contamination would be detrimental to the production process. The range of Euroblast cabinets from Guyson (Skipton, UK; www.guyson.co.uk) is offered in 316 L stainless steel; all ancillary internal parts such as turntables, door handles, assembly screws and so forth are also made from stainless steel. In addition, the internal walls of the blast chamber can be lined with rubber and critical metal parts such as turntables and the blast gun body can be coated with polyurethane to prevent the abrasive nature of the blast media from creating contamination. Options outside the cabinet include polyurethane pipes and wear-resistant elbows on the media extraction to the cyclone and polyurethane lining on the inside of the cyclone.

The Mediblast cabinets are compatible with a range of blast media types and grades, making them suitable for a variety of medical-related surface preparation, finishing and cleaning applications.

The system comes with an efficient dust collector to enable a clear view of the component surface whilst blasting operations are being conducted.