Showstoppers
A selection of innovative new products and services exhibited at MEDTEC (Amsterdam) and Motek (Sinsheim, Germany)
Plastics machining
Diffusion bonding produces smaller, more-efficient analyzers
Diffusion bonding technology, a proprietary process developed by Eastern Plastics Inc. (Bristol, CT, USA), eliminates most tubing, fittings, connectors, flow components, multiple fluid blocks, and subassemblies in chemical analyzers. OEMs can create a more-efficient and smaller fluidics package by utilizing this technology to produce a single, solid manifold. The firm, which specializes in precision plastic machining, engineering, and assembly, displayed several products showcasing this technique at MEDTEC.
"Because no adhesives are used, nothing carries over into the flow channels, and this is especially attractive to device companies," says company president and CEO Tom Brackett. Other benefits of this technology include a size reduction in the unit and the capability to use smaller reagent and sample volumes. "By doing away with components such as tubing and fittings and locating flow paths inside the manifold," Brackett adds, "we have eliminated potential leak points."
The company has manufactured manifolds up to 2 ft in length and as many as 10 layers thick. Channel sizes down to 250 µm can be achieved. Conductive elements, heaters, diaphragms, sensors, and valves can be embedded into the device, and each assembly undergoes full functional testing to ensure conformance to flow, pressure, leak, decay, and volume parameters. Materials typically used in the manufacture of diffusion-bonded manifolds include acrylic, polycarbonate, and PVC. "We also process other materials for use with different chemicals," adds Brackett. "For example, we are working with Ultem, a polyetherimide from GE Plastics, for DNA-type testing applications."
The company specializes in the fabrication of complex, close-tolerance components and works with hundreds of polymers to create machined components for the medical device industry.
Manufacturing equipment
Twin-track conveyor provides compact vertical and horizontal bends
A twin-track pallet conveyor can be configured with compact horizontal and vertical bends without requiring additional drive units. Developed by FlexLink AB (Göteborg, Sweden), the modular assembly equipment was shown at Motek.
The system is available in two designs: XT standard, a side-flexing chain that is used in main conveyor setups, and XT light for transfer units, workstations, and compact conveyor modules. Each module can be adapted to meet emerging assembly demands, ensuring a long lifetime of service. The larger platform size made possible by the twin-track conveyor makes the system suitable for use in the processing of items such as surgical kits, according to marketing manager Anders Pihl. Because FlexLink is present in a broad range of industries, he adds, it is well positioned to find novel assembly solutions for its customers in the device sector.
"We can take the best practices from each sector and adapt them to the needs of the device industry," says Pihl. "For example, we have extensive experience working with the electronics industry to neutralize electrostatic discharge, and our medical customers can benefit from this knowledge base." Both XT systems are available in antistatic versions.
Device manufacturers, which represent a growing part of the company's customers according to Pihl, are also attracted to the ease with which the system can be ramped up as production needs evolve. "You can go from a small low-tech setup to a high-tech system, and everything in between, very simply," says Pihl.
Testing equipment
Radiometer probe withstands prolonged exposure to heat
Light-curing adhesives are popular with device manufacturers because the rapid polymerization simplifies and speeds up production processes. However, the intensity of mercury vapour lamps that are used to cure the adhesives decreases with time, and this can result in significant problems in high-speed UV and visible-light curing processes. Dymax Europe GmbH (Frankfurt, Germany) introduced a radiometer at MEDTEC that can help to prevent such mishaps.
Accu-Cal DE 10 measures the intensity of UV and visible-light lamps in the 320–460-nm wavelength range; for narrower applications, probes suited for 320–400 and 400–480-nm wavelengths are also available. One of the novelties of the radiometer, according to Dymax representative Jürgen Eberhardt, is a probe that provides reliable and repeatable measurements even if it is maintained under the light source for extended periods of time.
"In previous models, the light sensor was very heat sensitive," says Eberhardt. "But on the Accu-Cal DE 10, the sensor is separate from the light input device, and the absence of heat sensitivity produces more-reliable results." Other enhancements noted by Eberhardt include fewer calibration requirements and the capability of measuring different wavelengths simply by changing the sensor head.
The radiometer includes dose and maximum-intensity measurements among its running modes, and operation can be automated.
Electronic components
Connectors developed for implantable applications
Ultraminiature electronic connectors suited for use in pacemakers, cochlear implants, implantable pumps, prosthetic devices, medical instrumentation, and related products are available in standard and custom models and in rectangular, circular, or irregular shapes. The Nano Interconnects were launched by Cristek Interconnects Inc. (Anaheim, CA, USA) at MEDTEC. According to company president Cristi Cristich, the connectors, which withstand harsh environments, vibration, shock, and high operating temperatures, are among the most reliable lightweight products on the market.
The connector shells can be constructed in metal or plastic, and mounting options include PCB, panel, or wire to wire. EMI filtering and hermetic versions are available.
A leading supplier of electronic connectors to the military and aerospace industries, Cristek's initial foray into the device industry came by way of Medtronic, which sourced Cristek over several competitors, some smaller and some much larger. Cristek prevailed over the other companies, says Cristich, because it was "small enough to shift gears when we needed to be flexible, yet we had established a reputation for reliability with our other customers. Our motto has always been, 'big enough to do the job, small enough to care.' "
The company is currently developing a multipin connector constructed entirely of biocompatible materials that can be directly implanted into bone.
IV components
Unrestricted flow channel designed into drainage valve
A supplier of plastic components to medical device OEMs has introduced a polypropylene drainage valve for urine bags that features a full-flow capability. Carmo (Espergaerde, Denmark) exhibited its slim-line cross valve at MEDTEC.
"PVC valves typically have a pin-in-hole design that can obstruct flow," says sales manager Ole Grip Michélsen. "The process that we use to make our polypropylene valves does not require that type of design and they are, in fact, free of any obstacles that would impede flow." The slim-line cross valve is competitive in price, adds Michélsen.
The valve, which can be moulded to customer specifications, is available in a wide variety of colours.
Manufacturing equipment
Aerosol tube assembly machine achieves 600 part-per-minute throughput
Continuous-motion aerosol tube assembly equipment achieves a 50% increase in throughput compared to indexing machines, according to Marie-Laure Forêt of Lagniel S.A. (Douvres-la-Délivrande, France). Depending on the size of the tubing, the custom equipment can process up to 600 parts per minute. The company presented its technology at Motek.
Suited for the cutting of tubing and its assembly with aerosol valves for use in medical and pharmaceutical products, the equipment incorporates quality control features that monitor the presence of parts and their handling. "Standard models of the machine accommodate tubes measuring between 0.1 and 0.8 in.," says Forêt, "but we can accommodate custom requirements as well." Likewise, while the machine accepts 12–20- in.-diam tubing spools, the feed system can be modified to suit other diameters or tubing-supply types.
Spool changeover is rapid because the support is mounted on a separate frame. For added convenience, two spools can be mounted on a single machine. Cutting length and fitting depth can be adjusted to an accuracy of ±0.2 in.
Adhesives
Fluorescent indicator eases in-line quality control
A light-curing adhesive and a two-part epoxy were among the adhesive solutions launched by Permabond (Eastleigh, Hamps, UK) at MEDTEC.
Because formulation 4L75 cures by means of visible or UV light, it is well suited for drainage systems and other reservoirs that may contain shaded areas, according to medical manager Laurie Gibbons. An indicator that is only visible under UV light facilitates in-line quality control procedures. The adhesive withstands impact and thermal cycling and it is compatible with ABS, acrylic, polyacetal, and polycarbonate, among other substrates.
One advantage of 4E90, the company's new two-component epoxy, over competing epoxies is a dispensing system that ensures the correct amounts are mixed together. Gibbons also stresses the product's long pot life. "One reason manufacturers may not want to use two-part epoxies is because of their short mix life," says Gibbons, "but we have developed the 4E90 to have a five-hour pot life." In addition, the adhesive's low viscosity ensures that it flows easily into all of the product areas. Curing takes 24 hours at 25°C; this can be reduced to between two and four hours by increasing the temperature. Typical applications of the 4E90 adhesive include catheters, needles, and other plastic disposables.
Motion control equipment
Electric actuator consumes one third less power than air cylinders
Described as an electromechanical alternative to air cylinders, a ball screw actuator offers multiple positioning and programmable control of acceleration, deceleration, and speed at a price comparable to equivalent air cylinder–type products. In addition, the relative power consumption of the Robo Cylinder is approximately 30% less than air cylinders. IAI Industrieroboter GmbH (Schwalbach, Germany) launched the line at Motek.
The system's enhanced capabilities compared with hydraulic systems and its environmental benefits at a competitive price make the Robo Cylinder an attractive alternative to air cylinders, according to managing director Haruo Onda. "Up to 16 positions can be programmed into the cylinder," says Onda. "Toyota, which evaluated our ball screw actuator package, was sufficiently impressed to give it an A rating." Other system features include positioning repeatability of ±0.02 mm and 5000 km of continuous travel at rated specifications without parts replacement. Operating the unit at a lower thrust will significantly increase its service life.
The unit is packaged with its own controller that includes both serial and parallel I/O capability. Up to 16 units can be controlled by using the serial port.
Testing equipment
Dual leak tester boosts productivity
By testing two parts simultaneously at production-line speeds, a dual-channel leak tester doubles productivity without the user incurring the cost of adding a second testing unit. An enhanced version of the M-1075, the tester also stores more than 1000 test records. InterTech Development Co. (Monkstown, Co. Dublin, Ireland), which supplies turnkey production test systems and instrumentation for leak, functional, and electrical testing, was an exhibitor at Motek.
"Basically, this unit delivers twice the power at half the price," says sales manager John O'Malley. "We have integrated a high-speed operation into one unit that can be used in-line at any stage."
Mass-flow sensing technology is combined with microprocessor controls to achieve direct measurement of leakage rates at cycle times of 0.3–2 seconds on test-part volumes of up to 25 cm3. A sensing range of up to 80 sccm at test pressures up to 100 psig can be accommodated. While the leak tester is well suited for testing valves and other small medical components, says O'Malley, it supports a broad range of applications involving products or components that must reliably contain a liquid, gas, or vacuum.
Measuring
Cleaning equipment
Ultrasonic cleaners combine compact size and modular design
The KT series of ultrasonic compact cleaners manufactured by Forward Technology Industries GmbH (Heppenheim, Germany) is designed for a variety of industrial applications, including cleaning of surgical instruments, glass cuvettes, pacemaker electrodes, hypodermic needles, pipettes, surgical thread spools, and surgical staples. The cleaners, which were displayed at MEDTEC, bear the CE marking.
The units are designed for ease of operation and can be supplied in fully automated models. They require only a small floor space, and all controls and drains are accessible from the front panels. The ultrasonic cleaning and cascade rinsing compartments are augmented by a modular drying unit that operates on hot circulating air. Marketing manager Edith Müller notes that the units achieve economy in space and cost: "Our cleaners combine three separate units: an ultrasonic cleaner, a rinsing compartment, and a drying unit."
A handling system is available as a complement to the Model-KT25 compact cleaner. All process parameters are PLC controlled. In addition to reducing personnel costs, the handling system optimizes throughput and controls all cleaning operations to ensure repeatable results. Cleanroom models are also available.
Assembly machines
Linear assembly system allows easy access for change tooling
A high-throughput linear system for the assembly, testing, and packaging of disposable medical devices achieves rates of 800 parts per minute in needle hub assembly applications and provides easy access to tooling.
Lawrence Davie, managing director at Arthur G. Russell Ltd. (Arbroath, Tayside, UK), says, "Accessibility was the primary issue in the system's design. As regulatory needs increase testing requirements or perhaps necessitate the addition of new modules such as vision systems, manufacturers need the flexibility to modify their assembly systems."
According to Davie, the Linear 2010 has lower operating costs than rotary assembly systems. "One operator can manage two of these machines," he says. Ease of access for system modifications and reduced time for change tooling also contribute to reduced operating costs. The company, which exhibited at MEDTEC, offers a range of machine formats for various applications and customer requirements.
Testing equipment
Leak detection system incorporates proprietary test fixtures
Pouches, blister packs, jars, bottles, and vials can be tested on a helium leak detection system. A vacuum test fixture, head-space analysis module, and a data acquisition and analysis module combine to make the SIMS 1282+ an integrated, oil-free package-integrity monitoring system with applications in the pharmaceutical and medical industries.
The sensitivity of the gas spectrometer permits the testing of packaged products with seal requirements ranging from gross leaks to ultrafine leaks, and an oil-free pump reduces the risk of inaccuracies from oil vapours. Jeffrey Morrow-Lucas, vice president of Leak Detection Associates (Williamstown, NJ, USA), says, "This system can detect leaks well beyond the range of 10–10 cm3/sec, which makes it superior to bubble or dye-penetration methods."
Both the leak detector itself and the associated software are fully validated. The system, which was shown at MEDTEC, is supplied as a turnkey unit; customers need only supply electrical power and helium and nitrogen gas. Through a joint venture with Alcatel Vacuum Technology France (Annecy, France), the company provides training, technical support, and product service programmes worldwide.
Flowmeters
Gas mass flowmeters suited for anaesthesia applications
With an accuracy level of 2% and a response time of 4 milliseconds, a series of gas mass flowmeters is suitable for use in ventilators and anaesthesia equipment. The series made its debut appearance at MEDTEC.
"Other companies make flowmeters for industrial applications that are not suited for the medical sector," says Ulrich Kohlhaas, sales manager at TSI GmbH (Aachen, Germany). "Our Series-4100 flowmeters have a fast response time and can be used to track breathing cycles," he adds. The units, which feature high speed and low back pressure, can be used to measure low flow ranges of air, oxygen, and nitrous oxide from 0.010 to 20 std L/min.
The 4100-series was developed in response to a challenge to the company's engineers and can be supplied with or without an LCD display. Data are transmitted through an RS-232 serial port or an analogue output.
Surface treatment equipment
Affordable plasma system suited for bonding applications
Plastics and textiles can be pretreated to enhance bonding characteristics with a plasma system that provides an alternative to mechanical and chemical surface treatments. The Junior plasma system from Europlasma (Oudenaarde, Belgium) can treat a variety of substrates including composites, engineering thermoplastics, and electronic devices. Medical applications include air filters, catheter assemblies, and barrier coatings.
The unit, displayed at MEDTEC, modifies surface layers by generating a microwave frequency to produce a high concentration of free radicals on even the most stable surfaces. The Junior comes with a chamber measuring
The company's managing director, Anthony Vanlandeghem, explains that the Junior is suitable for use in R&D and laboratory environments. "We see a niche market for a small plasma system. Many manufacturers are working on new products that are highly confidential, and they need a low-cost system to perform their testing in-house." Europlasma also offers process development and testing services.
Light-curing system
Portable light-curing system operates in UV and visible wavelengths
A high-intensity, portable, floodlight curing system delivers more than 100 mW/cm2 of UV energy at a peak wavelength of 365 nm or 500 mW/cm2 of visible light energy at 450 nm. The ELC4001 uses a high-pressure, custom-designed 400-W lamp, available in either the standard or the UV wavelength.
The system, which was on display at MEDTEC, incorporates an internal heat-exhaust system, enabling the ELC4001 to provide maximum light intensity at reduced operating temperatures. The modular design of the system permits multiple light modules to be positioned end to end for expanded-area applications. For single-module, benchtop applications, an adjustable curing frame with optical shield is available. Applications include assembly of disposable ECG sensors. "The modular design allows manufacturers to customize their system in a building-block fashion for batch curing," says Charles Vassalio, vice president and general manager at Electro-Lite Corp. (Danbury, CT, USA).
Adhesives
Multisurface silicone adhesive cures at room temperature
Developed by Applied Silicone Corp. (Derby, UK), an adhesive is vulcanized at room temperature by exposure to ambient moisture to form a tough, elastic bond. RTV Multisurface silicone adhesive PN 50084 is a high-strength, one-part product designed to form bonds to silicone, polyester, acrylic, polyurethane, and polysulphone along with other substrates. The adhesive can be sterilized by EtO, steam, dry heat, or gamma radiation.
At MEDTEC, the company's CEO Alastair Winn emphasized the unique achievements of the adhesive: "We developed a technique to modify the surface energy of silicone. We are unaware of any other technology like this on the market." Typical medical applications include the bonding of catheter balloons, pump diaphragms, and masks. "Basically, the adhesive is suited for any application joining silicone with a nonsilicone substrate," says Winn. Biocompatibility studies are under way for specific customer applications.
IV components
Needleless transfer device designed for haemophilia applications
Designed to eliminate the risk of needle sticks in haemophilia drug delivery, a needleless transfer device was developed by Medimop Medical Projects Ltd. (Ra'anana, Israel) and displayed at MEDTEC.
Company president Freddy Zinger explains that the transfer device was developed to eliminate the need for transfer needles and filter needles in haemophilia drug therapy. "We've added features with the safety of the end-user in mind," he says. A flared rim guides vials into place, where they are automatically pierced. A syringe can then be connected to an opening in the device, filled with air, and aspirated with the contents of the drug vial. An embedded filter eliminates the risk of filter bypass. Medimop developed the component over two years of trials and plans to supply it to pharmaceutical companies. The firm also manufactures pump technology for IV applications, as well as a line of ampoule and mix adapters.
