Showstoppers
A selection of innovative new products and services exhibited at Electronica (München), Emballage (Paris), Medica (Düsseldorf), and Medical Design & Manufacturing West (Anaheim, CA, USA)
Packaging equipment
Form-fill-seal equipment designed to process PVC-free IV bags
Form-fill-seal equipment designed for processing IV bags made of PVC-alternative materials can produce 50-ml–5-L bags from a single-width reel. Development of the stainless-steel machine was announced by Thimonnier (Saint-Germain-au-Mont-d'Or, France) at Medica in Düsseldorf, Germany.
"All of the bag formats can be produced from a single roll width, thereby reducing the number of changeovers," says marketing director Bruno Clement. When changeovers are required, they can be done rapidly using integrated "minute-change" pneumatic-lock sealing tools. The machine accommodates three types of port systems and roll widths, as well as single- and double-wound and tubular rolls. More than 100 programs can be stored in memory.
A mechanical servomotor drive design ensures quick and accurate strokes. The sealing tools are made of a steel-chromium-Teflon compound for rapid, nonstick operation at stable temperatures. Equipped with cycling optimization software, the machine attains a throughput of up 3600 units/hr.
Manufacturing equipment
Ampoule-filling system equipped with laser sealer
Replacing a conventional gas sealing system with a laser sealer in an ampoule filling and sealing machine reportedly enhances equipment safety and performance. The system was presented by Bausch + Ströbel GmbH + Co. KG (Ilshofen, Germany) at the recent Emballage exhibition in Paris.
The LSS laser sealer can be installed away from the work area, which is advantageous when the filling machine is installed inside a sterile room, explains the company's US-based sales manager Robert Durner. "A further advantage is that there are no components to cause turbulence in the laminar airflow." Because the system operates without a gas burner or ignition device, no soot is generated. The laser sealer also produces fewer particles than gas burners and does not require permanent contamination monitoring.
According to tests conducted by the firm comparing ampoules that were sealed using gas burners to those processed by lasers, there was no difference in the glass tension, according to Durner, but "the affected area in the laser-processed ampoule was smaller. Less glass melted, showing that less heat is generated in the container," says Durner.
Other benefits include shorter set-up times, lower rejection rates, and maintenance-free operation for at least 15,000 hours of use. Several safety features have been built into the LSS: the laser beam is activated only if a container is present, and the machine shuts down immediately if the machine guard is opened.
Bausch + Ströbel supplies custom production lines for processing ampoules, vials, cartridges, infusion bottles, and disposable syringes. Modular construction principles enable individual machines to be linked to form integrated production lines. A selection of compatible washing, sterilization, filling, closing, inspection, and labelling machines is available.
Electrical components
Medical-grade 24-W cord set fitted with retractable plug
A 24-W switch-mode power supply with a proprietary swiveling wall plug complies with medical electrical standard EN 60601. "To my knowledge, it is the only 24-W unit on the market with medical-grade certification," says Denny Seiger, marketing director at Egston GmbH (Eggenburg, Austria), who presented the company's product line at the Electronica trade show in München, Germany. The unit is available with plugs adapted for use in all European countries, the United States, and Japan, and offers 100–264-V ac inputs. Output voltages between 5 and 24 V dc feature ±3% stability. Medical applications include infusion pumps.
The company designs and manufactures standard and custom power supplies based on existing platforms. According to Seiger, this enables the firm to accelerate the development of custom designs and to optimize production methods. The 24-W wall plug is based on the standard N2 platform that incorporates a wide range of inputs and current limiters. Medical- grade N1 platform models are also available. Versions based on the N1 platform are potted for use in operating temperatures from –20° to 50°C.
"The use of platforms is a core part of our design philosophy for OEM products," says Seiger. "It allows us to deliver cost-effective components with short lead times." The company routinely builds customer-specific variants, and can easily incorporate voltages, output tolerances, and other features requested by OEMs. "If we can't meet customer specifications using one of our existing platforms, we will create a new platform," adds Seiger.
IV components
Disposable syringe can be used with a single hand
A clear plastic case that mounts on a prefillable disposable syringe prevents injuries caused by needlesticks and enables one-handed operation. When pressure is applied on the plunger rod, the plastic case slides forward and locks into position, covering the syringe barrel and needle. Developed by Gerresheimer Glas AG (Düsseldorf, Germany), the Safety system "not only prevents needlestick-related injuries but it makes reuse of the syringe impossible," says marketing director H. Burkhard Lingenberg. The firm demonstrated the product at Emballage in Paris.
The Safety system is suited for use with all types of syringes. Adoption of the system does not necessitate any changes in the manufacturer's sterile processing procedures or in the primary container or syringe design, according to Lingenberg. Anticipating substantial global demand for this product, Gerresheimer is currently building a new facility for the production of the device.
The company also displayed currently available prefillable disposable syringes that employ this technology. Safetyject was developed by Bünder Glas, a subsidiary of Gerresheimer; it is suited for use with 1-ml glass syringes but it can be adapted to other sizes. The product received the 2000 German Packaging and World Star awards.
Sensors
Temperature sensor characterized by easy installation, low cost
A company that develops components for use in thermal design and electronics presented its newest temperature sensor at Medica in Düsseldorf, Germany. Supplied by Minco EC (Niederuzwil, Switzerland), Thermal-Tab consists of a highly stable platinum resistance temperature detector packaged in a flat body. The low-cost device is suited for mounting on surfaces or for insertion into probes or cavities.
The sensor is completely insulated and has rugged Teflon-insulated lead wires in standard 1-m lengths. Element types include Pt100 and Pt1000; other curves, including NTC or PTC thermistors, are available. Measuring 5 x 12 mm, the sensor has a temperature range of –50° to 130°C.
Thermal-Tab is easily installed on surfaces using self-adhesive backing or cements, epoxies, and tapes. It can also be assembled into probes by sliding it into the sheath and securing it with potting or a mechanical crimp.
The company also supplies an array of temperature control products and electronic interconnects for use in medical device applications.
Manufacturing equipment
Laser die-cutting machine attains 350 m/min output
Offered as an alternative to conventional die-cutting machines that require costly custom tooling susceptible to wear, a laser converting system is suited for the production of flexible packaging and medical products. The computerized laser die-cutting machine was developed by Schober GmbH (Eberdingen, Germany), an exhibitor at Emballage in Paris.
The machine performs cutting, kiss cutting, perforation, welding, and marking operations on film, foil, paper, nowovens, textiles, and multilayer materials. "There are some material limitations," notes sales manager Gerald Glaas. "For laminated applications, for example, mechanical punching remains the best method." Prospective customers who are unsure about the suitability of the technology for their particular application are invited to make use of the reel-to-reel machine set up at the Schober facility for testing purposes. "Schober is one of the only suppliers that conducts laser cutting tests under production conditions," says Glaas.
The laser punching and die-cutting system currently is being used in the manufacture of IVD products, according to Glaas.
Testing equipment
Plug-and-play materials tester features 5-kN force capability
Incorporating sophisticated electronics, a materials tester is designed to enable even inexperienced users to perform tests by means of simple keystrokes. With a 5-kN force capability, the unit can be used to test a range of materials from plastics and paper to electrical components. The LRXPlus was presented by Lloyd Instruments S.A. (Montigny le Bretonneux, France), a division of Ametek Inc., at Emballage in Paris.
The plug-and-play unit automatically identifies load cells, extensometers, and other instruments attached to it. New creep and relaxation programs that accompany tensile, compression, flexural, and cycling modes, and rapid sampling rates allow for detailed measurements and analyses that can benefit research, production, and quality control functions.
The machine can store up to 10 user-defined programs that are password protected to prevent less-experienced users from disrupting key set-ups. It can be used as a stand-alone instrument or in tandem with the company's Nexygen software.
A 32-bit flash processor is incorporated into the LRXPlus to enable system upgrades via the Internet. A comprehensive range of accessories and grips are available.
The tester exceeds the requirements of ASTM E4, DIN 51221, and BS EN ISO 7500-1:1999.
Labelling equipment
Labelling machine accommodates round and square products
A labelling machine that can apply up to three labels on round or square products achieves a maximum throughput of 3000 units per hour. Albagnac (Sauzet, France) exhibited the stainless-steel machine, called Xena, at the Emballage packaging show in Paris.
The integrated electronic control panel can store up to 99 programs and was designed for ease of use, notes sales executive Patrice Blanc. An integrated thermal transfer unit can add lot numbers, expiry dates, logos, and related items to labels. Lot numbers can also be marked by means of incision. "The incision unit works without ink or ribbon and is virtually maintenance free," says Blanc.
Labels with a maximum height of 170 mm can be processed on standard equipment, although the machine can be configured to accept 200-mm labels upon customer request.
Printing equipment
Compact thermal printer introduced
A recently introduced 50-mm thermal printer reportedly is smaller and lighter than competing products currently on the market. GSI Lumonics GmbH (Unterschleissheim, Germany) exhibited the XE-50 at Medica in Düsseldorf, Germany.
Easy to mount, the XE-50 accepts 50-mm-diam rolls. Enhancements designed into the printer include trending speeds down to 1 mm/hr and a choice of two print sizes.
Manufacturing services
Supplier of cardiovascular products collaborates with university
Espousing innovative R&D and end-user-driven engineering, a company supplies guidewires, balloon catheters, stents, and stent delivery systems. Eucatech (Bad Kissingen, Germany), which exhibited its capabilities at Medica in Düsseldorf, Germany, is a "relatively new company," says managing director Michael Giese. "It was founded three years ago, and we have been doing OEM activities for only two years," he adds. Despite its newcomer status, the company has been quite successful, stresses Giese: "We currently produce about 20,000 OEM catheters annually." A key reason for the company's rapid rise, he maintains, is its focus on innovation. To ensure that it stays current with developments in materials science, for example, the company works closely with the polymers department at the University of Erlangen-Nürnberg.
Tubing produced by Eucatech is characterized by high dimensional stability, which is ensured by the use of a homogeneous extrusion process.
PTFE-coated 0.014-in. guidewires supplied by the firm feature a full-length tapered core to enhance insertion and 1:1 torque transmission. Semicompliant balloon dilation catheters are available with 1.5- to 5-mm balloons and in 10-, 12-, 15-, 20-, and 30-mm lengths.
Electronic components
Developer of integrated circuits targets wireless device applications
Touting the "virtual wire," a company focussing on wireless applications develops, markets, and sells standard off-the-shelf integrated circuits (ICs) as well as application-specific ICs (ASICs) based on customer specifications. Nordic VLSI ASA (Tiller, Norway) presented its family of radio-frequency (RF) transceivers and transmitters at Electronica in München, Germany.
"We have a portfolio of RF products suited for use in the industrial, scientific, medical (ISM) frequency bands," notes marketing director Geir Langeland. One such product is the nRF403 single-chip transceiver designed to operate in the 315- and 433-MHz ISM bands and which is integrated into a hearing aid. "It is used to adjust device parameters," explains Langeland, who describes it as a "wireless system, rather than an inductive loop, that alerts the user to events occurring in the home, such as the ringing of the phone or doorbell." It can also be configured as an access control device for wheelchair users. The company has also developed a set of two ASICs that perform front-end calculation-intensive signal processing for ultrasound equipment marketed by GE Vingmed Ultrasound.
A current project at Nordic involves the wireless transfer of ECG data. "This is still in the early stages of development and there is some concern among hospitals regarding RF noise," says Langeland, but the benefits are obvious. "The ECG monitor needs to be wheeled close to the patient, and these units typically have a lot of wires attached to them." Eliminating those wires without compromising the safety of the patient or the efficacy of the device has immense market potential, Langeland believes.
Catheter-processing equipment
High-speed tipping and moulding equipment introduced
A new line of precision catheter-tipping and moulding equipment can ramp up to 450°F in less than 1 second. In addition to a fast run-up time, the Cath-Pro machines developed by Rubicon Medical Inc. (Salt Lake City, UT, USA) and shown at Medical Design & Manufacturing West in Anaheim, CA, USA, provide users with a "wide window of processing opportunity," according to Marlin Struhs, director of sales and marketing. "Cath-Pro holds the temperature for a longer period of time than competing systems," which may experience temperature drift, says Struhs.
Cath-Pro can weld, form, or tip any thermoplastic material. An integrated stepping motor drive ensures consistent and precise results even with tight-tolerance products. Making the machine easy to use was also a priority in system design, according to Struhs. Programmable controls allow operators to run multiple projects on the same machine; tooling changeover is a routine one-step process.
Rubicon's new tipping system can process round or irregular tips, perform multilumen shape transitions and soft tip fusions, and form neck-downs. Balloon-to-catheter, butt, and annular welding are also among its capabilities.
The company offers custom OEM catheter tipping and forming at its facility using its Cath-Pro line of machines.
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