Showstoppers
A selection of innovative new products and services exhibited at MD&M West 99 (Anaheim, CA, USA)
Printing supplies
UV-curable pad-printing inks equal performance of two-part epoxies
Developed specifically for use with pad-printing machines, a line of UV-curable inks combine transfer quality with adhesion, abrasion, and chemical resistance. Launched by UVEXS Inc. (Sunnyvale, CA, USA), Luxicure inks combine the benefits of UV curing with the performance of two-part epoxy inks, according to sales and marketing manager Charles Tucker.
"Our goal in formulating these inks was to improve print quality and maximize productivity," says Tucker. Among the brand's features, he cites its instant-cure capability, low-temperature exposure, indefinite pot life, bright colours, and durable markings. The inks do not dry in the inkwell, which facilitates cleaning, while the wet-on-wet printing capability maximizes multicolour printing productivity because a single cure stage is sufficient. Abrasion resistance is at maximum performance immediately after curing, enabling handling and packaging operations to begin without delay.
Luxicure inks may be used with open-well or closed-cup printers and may be thinned to suit specific printing requirements. They also have a lower solvent content than air-dry or two-part inks, resulting in a substantial reduction of volatile emissions during the printing process.
The 304-series inks are formulated for ABS, vinyl, polycarbonate, and filled nylons; the 306-series is suited for glass, quartz, and glass-filled plastics. "We can custom-match any colour," adds Tucker.
UVEXS also exhibited at MD&M West 99 a compact UV flood station that provides a controlled flood exposure over a 6-sq-in. area. "The MAC is designed for easy system integration," says Tucker, who adds that the curing device is intended to bridge the gap between spot-cure systems and full-scale UV irradiator installations. The unit does not yet have a CE marking, however.
Pressure-sensitive adhesives
Card-form PSAs, enhanced tapes launched
A supplier of standard medical-grade pressure-sensitive adhesives, Adhesives Research Europe Ltd. (Great Dunmow, Essex, UK), introduced adhesives in card form at the recent MD&M West 99. The format is suited for manufacturers with smaller or semiautomated production runs of diagnostic testing products.
The company also presented a line of enhanced products. ARcare 8565 is a firm tape to which a membrane can be laminated. It comprises a 10-mil white PET carrier, that provides visual readability, and a 2-mil clear liner. ARcare 7815 tape uses a thin, flexible, clear 2-mil PET carrier to facilitate flow of the patient sample to the membrane while protecting the indication area from exposure to unwanted samples. It is applied to the top of the final construction.
The company's medical business unit offers nearly 30 standard products designed for use in diagnostic, medical device, and wound-care applications. The extensive standard product line is of great value to customers, says general manager Kären Olson from the company's US headquarters in Glen Rock, PA. "These PSA tapes have a proven track record in similar applications," she says. "Since they are standard products, our customers have access to them without the time involved in custom development." The company can also accommodate requests for custom PSA tapes designed to meet new or unique applications.
Electric components
Power-entry modules include low-leakage RFI filter
Power-entry modules that incorporate up to six functions in a compact package can be supplied with a radio-frequency-interference filter designed for use in medical equipment. The components meet the specifications of IEC 950 as well as the low-leakage requirements—less than 5 mA—that are often required in healthcare environments. Medical-grade modules also incorporate a bleed resistor that drains residual current from filter capacitors after the power plug has been removed, making them suitable for use in IEC 601– and UL 2601–rated equipment. Schurter AG (Luzern, Switzerland) exhibited its GRM series of power-entry modules at MD&M West 99.
The power-entry modules feature a host of other innovations, according to Joe Hamilton from Schurter's US operations, such as a space-saving design, ease of assembly, and technology that facilitates EMC compliance.
The square-shaped unit measures only 26 mm deep, filter included, yet offers the same number of functions as conventional rectangular packages.
The company's "lock and shield" mounting process enables the module to be wired prior to assembly, saving manufacturers valuable time. The snap-in component mounts on the panel from the inside of the equipment; its locking system ensures that the module does not pop out even if the plug is subjected to excessive pushing or pulling.
A metal shield positioned between the inlet and the panel opening provides protection against radiated emissions. The module is designed to properly route electromagnetic interference and to prevent it from migrating through the machine. This can prevent expensive redesigns when the final device is subjected to stringent testing for electromagnetic compliance.
A recently published brochure that describes the company's complete range of power-entry modules suited for use in medical equipment is available to design engineers and manufacturers.
Materials
High-throughput vinyl withstands exposure to gamma sterilization
A new heat-stabilizer formulation for clear flexible vinyl compounds reportedly achieves a higher throughput than conventional polyvinyl chloride while yielding products with equivalent or better resistance to gamma sterilization. Peter W. Galland, medical industry manager for Teknor Apex (Pawtucket, RI, USA), made the announcement at MD&M West 99.
"With conventional heat stabilizers that meet US FDA requirements for medical applications, the gamma resistance of vinyl falls off as heat stability increases," says Galland. "To avoid the discolouration and property losses caused by irradiation, manufacturers of medical products have had to use gamma-resistant compounds with lower than desirable levels of heat stability. Our new stabilizer formulation not only ends this trade-off but actually yields somewhat better colour retention after sterilization," Galland says.
When processed under high heat and shear, the PVC in conventional gamma-resistant vinyl may decompose, yielding defective products or causing frequent downtime while the degraded material is removed from screen packs. Compounds that incorporate the company's stabilizer enable manufacturers to boost productivity by reducing downtime or increasing line speeds, according to Galland.
The stabilizer formulation has been incorporated into existing grades of the company's vinyl. Several of the compounds have been fully tested for compliance with USP Class VI and cytotoxicity standards.
Materials
Low-nickel alloy suited for implant use
Developed to help prevent allergic reactions to nickel, an alloy's nominal chemistry is 21% chrome, 23% manganese, 1% nitrogen, 0.7% molybdenum, and less than 0.3% nickel. Iron makes up the balance of the BioDur 108 alloy, which was introduced by Carpenter Technology Corp. (Reading, PA, USA) at MD&M West 99. Potential applications include bone screws, bone plates, and other orthopaedic devices.
The impetus to develop this material came largely from European industry, according to product application manager Robert S. Brown. "A significant part of the world population has allergies to nickel," says Brown. "We wanted to offer our customers an alternative to titanium—a virtually nickel-free alloy suited for the fabrication of fracture fixation devices and implants." Carpenter has taken the fairly unusual step of subjecting the material to biocompatibility testing. "We did this as a courtesy to our potential customers since it is a brand new material," Brown adds.
Because of its high chromium, nitrogen, and molybdenum content, BioDur 108 has exceptional corrosion resistance, Brown says. Bars in this alloy show an ultimate 931 MPa tensile strength in the annealed state with approximately 50% elongation.
The company's subsidiary Dynamet also introduced profiled titanium bars at the exhibition. The profiles, available in a number of titanium alloys, are suited for bone plates, spinal fixation devices, and dental implants.
Dispenser
UV adhesive system features precise, repeatable operation
A benchtop dispenser rapidly deposits precise, repeatable amounts of UV-curable adhesive on polyvinyl chloride, ABS, and other medical-grade polymers. Suited for dispensing applications on the inner or outer surfaces of tubing, conical parts, needles, and assorted connectors and components, a prototype of the unit was exhibited at MD&M West 99 by TechnoMed Inc. (Salem, NH, USA), part of the Medica group headquartered in Medolla (MO), Italy.
"The user simply inserts the tubing or component into the bushing until it reaches the stop point," says general manager Luciano Fecondini. "An adhesive film is dispensed all around the surface of the part and it is ready to be bonded to the assembly."
The U.V.A.D.'s sealed dispensing system reduces material evaporation and ensures the deposit of reproducible amounts of adhesive, thereby eliminating waste. Futhermore, adds Fecondini, light does not penetrate the dispenser's interior, eliminating unwanted polymerization of the UV adhesive.
The U.V.A.D. can process parts measuring 1.3 to 8 mm; bushings adapted to various diameters are available on a custom basis and can be easily fitted onto the dispenser.
Laser cutting equipment
System offers turnkey stent production
A new laser cutting system from Lumonics (Unterschleissheim, Germany) is reportedly the first dedicated turnkey system for stent production. The StentCut 1000 is manufactured from fully designed, engineered, and documented modules currently used for stent cutting or other fine machining systems.
At MD&M West 99, product manager Michael Delbusso emphasized the system's high level of integration. "What distinguishes the StentCut 1000 from other products aimed at similar applications is that it is the only true turnkey system offered by a single-source vendor for cutting stents."
The StentCut 1000 achieves high throughput with a high-repetition, 350-W pulsed Nd:YAG laser used in other Lumonics cutting systems. "The unit offers both laser controls and system controls," explains Delbusso, "allowing different laser strengths to be programmed. It is very fast and produces high-quality cuts."
The PC-based control system includes software for the rapid conversion of designs to cutting programs. The system also features automated tube indexing as well as network-ready software for documenting process conditions.
The StentCut 1000 requires a floor space of 5.5 x 4.3 m. Lumonics offers extensive training and service programmes for the unit, which is currently being introduced in the North American market. It will be launched in Europe as soon as it receives CE marking.
Materials
Lipid-resistant compound shows no deterioration after sterilization
An acrylic-based multipolymer offering high chemical resistance is available from Cyro Industries (Rockaway, NJ, USA). Cyrolite CG-97 was developed for applications requiring maximum resistance to lipids and PVC plasticizers.
CG-97 offers better chemical resistance than lipid-resistant polycarbonate and also features enhanced initial light transmission and superior clarity after irradiation. The compound exhibits no property deterioration after standard levels of gamma irradiation, but shifts to a permanent blue-green tint, allowing medical parts to be sent directly to market.
At MD&M West 99, business manager Steve Magaziner underscored that "CG-97 has been in development for three years and was designed exclusively for use in the medical industry."
Magaziner also emphasizes the material's cost-effectiveness. "This compound has a lower cost than polycarbonate and exhibits improved qualities. And it is less dense than polycarbonate, which means that less material is required."
The transparent compound is suited for injection moulding in a variety of device applications. Its excellent processability at low temperatures makes it suitable for thin-walled devices, multicavity configurations, and other difficult-to-fill parts like filter housings, luer locks, and IV accessories. CG-97 is marketed in Europe through Cyro's parent company Röhm GmbH (Darmstadt, Germany).
Welding equipment
Desktop laser welding station includes gas-handling system
A self-contained desktop laser welding station from Equilasers Inc. (Sunnyvale, CA, USA) is reportedly the world's smallest industrial laser. Designed for both R&D and production, the EDWS-15 laser welding station is suited for applications that require the precise joining of metal components, such as pacemakers, electrical contacts, and miniature medical devices. The unit was on display at MD&M West 99.
For processes that require welding in the presence of inert gas, a gas-handling system with flow-rate adjustment is included. Gas flow and the laser-firing sequence are controlled through a two-stage foot switch. Gas-delivery accessories are provided to allow the user to direct the gas onto the workpiece from different angles and distances. The system, explains Richard Sam, president of Equilasers, "provides extremely clean welds with titanium."
The welding station, which is based on a 15-W Nd:YAG laser, includes a miniature, high-resolution colour camera and monitor. The EDWS-15 is capable of spot sizes as small as 80 mm. A high-magnification vision system uses an optical fibre and viewing assembly to ensure precise beam positioning. The focusing assembly is attached to a set of x, y, and z translation stages, and the x-y stages are servomotor driven with a linear resolution and repeatability up to ±0.0001 in. The station has a footprint of 3 x 5 ft and weighs only 65 lb.
The company is currently completing work toward CE marking for the system.
Packaging equipment
Two-station heat sealer cuts production time
A heat-sealing machine for the medical device industry was displayed at MD&M West 99 by Alloyd Company, Inc. (DeKalb, IL, USA). The model 2SM1216, which occupies a space of 1.4 m2, features dual-shuttle trays, a software operating system, and an LCD touch screen.
Each two-station medical heat-sealing machine includes two manually operated shuttle trays measuring 12 in. deep x 16 in. wide. The shuttle trays are alternately positioned beneath a heating platen that seals prenested lids and trays. Two machine operators can feed, fill, seal, and remove sealed medical trays at the rate of 2000 to 4000 packages in an 8-hour shift. The 2SM1216 can also be outfitted with optional medical heat-seal tooling, including Teflon-coated heater blocks, anodized aluminium components, t-shaped sealing gaskets, and quick-change tooling.
The machine features extensive software control, including a PC operating system that can control up to 10 two-station sealing units by specifying parameters for seal time, seal pressure, and temperature. The software interface is also designed to meet the validation needs of medical tray packaging manufacturers. Machine performance is monitored and recorded for every cycle, and detailed project histories are stored in a database format for retrieval and analysis.
Product marketing manager Kent Hayward emphasizes the machine's use of automation. "We've reduced the amount of human input in the data-entry process in order to decrease the occurrence of errors." An optional keyboard and bar code scanner allow operators to quickly and accurately select process configurations by entering alphanumeric text or scanning bar code symbology.
Alloyd is currently working on obtaining CE marking for the machine, and hopes to receive certification within the year.
