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Articles from 2001 In November


Medical-Grade Packaging Papers Take on Spunbonded Olefin

Originally Published MPMN November 2001

PRODUCT UPDATE

Medical-Grade Packaging Papers Take on Spunbonded Olefin

High-strength, high-barrier papers may reduce manufacturing costs

In order to be considered for use in medical packaging, a material must possess a number of characteristics. It must be compatible with commonly used sterilization processes. It must provide a strong barrier to bacterial penetration. It must run smoothly on a variety of packaging equipment without creating static electricity that could attract airborne particles. It must have a smooth surface that enables clear graphics. It must not break down in moist or wet conditions. It must be clean peeling—opening a package shouldn't trigger the release of fibers that could threaten a clean environment. And of course it should be strong enough to resist tearing.

Traditionally, manufacturers in need of a high-strength, high-barrier, breathable material for their medical form-fill-seal packaging and lidding needs have turned to spunbonded olefin, made by DuPont Medical Packaging. Spunbonded olefin, known as Tyvek, is manufactured by using heat and pressure to bond very fine continuous filaments of high-density polyethylene (HDPE) together. It is chemically inert, naturally white, and contains no binders or fillers.

Because it meets or exceeds medical standards, Tyvek has long dominated the sterile medical device packaging industry. However, cost has been a factor for some manufacturers in using this product, leading them to turn to less-expensive medical-grade papers for packaging applications that don't require the highest quality materials.

While acceptable for some uses, papers have drawbacks that make them less desirable in sterile packaging. These include a susceptability to tearing, especially in moist or wet conditions, reduced barrier properties, and a tendency to release fibers when opened.

Paper alternatives show strength

Recently, though, advances have been made in paper formulations. Two suppliers now offer papers as alternatives to spunbonded olefin. These new products offer many of the characteristics of spunbonded olefin, but are available at a lower cost.

Two puncture-resistant, medical-grade papers from Bomarko Medical Packaging, TA 100 and TA 115, are specifically intended for products that need high-performance protection at a reasonable cost.

"The main reason for the lower cost is that paper has more competition than spunbonded olefin," says Kimball Mancke, president and chief operating officer of Bomarko Medical Packaging. "When a new product is developed and has no competition, the price remains at a high level until more alternatives become available. This is the change we're experiencing in the marketplace today."

Two puncture-resistant, medical-grade papers from Bomarko Medical Packaging exhibit strength and barrier properties. Through the use of high-performance coatings, the TA100 and TA115 products provide a fiber-free peel with consistent coating transfer.

"Of course there are products that need the qualities of spunbonded olefin; however, there are many soft or smooth products that can be packaged in a different substrate without incurring the expense of spunbonded olefin," says Mancke. "Bomarko Medical Packaging offers TA 100 and TA 115, which are specifically intended for use with products that need high-performance protection at a sensible cost."

Both grades of paper are suitable for a range of packaging applications including form-fill-seal and lid stock. Typical items packaged include gloves, gauze, soft or smooth products, flat packs, and products with low-definition packaging needs that do not require overengineered spunbonded olefin.

Impervon from Kimberly-Clark Technical Paper is a high-strength, high-barrier reinforced paper incorporating a proprietary polymer.

Another medical packaging company, Kimberly-Clark Technical Paper, offers a high-strength, high-barrier reinforced paper that incorporates a proprietary polymer. Impervon seals directly to a wide variety of multilayer films, is easily printable, and provides a high internal bond strength that resists tearing in many medical packaging applications. It is engineered to perform on form-fill-seal, rotary, platen, shuttle, pouch-making, and bar-sealer equipment and offers high opacity, drapability, and printability.

All three papers work effectively with commonly used sterilization methods.

DuPont has also stayed on top of the cost-cutting trends among manufacturers. The company has designed Tyvek 2FS as a lower-cost alternative to medical-grade Tyvek. This lower-basis-weight style of spunbonded olefin is designed specifically for less-demanding flexible packaging applications.

The opaque, white material provides high print contrast and easily makes bar codes readable. A TiO2 additive makes 2FS resistant to the formation of transparent seals. It can reduce material costs because it has a low basis weight and high strength. This combination enables the design of cost-effective packages that process with high yield and survive the distribution environment with few product returns.

Susan Wallace

Copyright ©2001 Medical Product Manufacturing News

CO2 and UV Laser Systems Accurately Cut Complex Shapes

Originally Published MPMN November 2001

EQUIPMENT NEWS: Laser Processing

CO2 and UV Laser Systems Accurately Cut Complex Shapes

Systems are quick, versatile, and easy to use

Laser welding, cutting, and marking systems offer a number of features that make them suitable for medical device manufacturing applications. New systems that meet the stringent demands of the industry are discussed in this section. For example, two roll- and sheet-fed systems using either a CO2 or UV laser source can process a variety of materials. Other products presented include a diode-pumped solid-state module that provides 750 W of power at 1064 nm, a pulsed Nd:YAG laser with a variety of power output options, and a compact, portable excimer laser system.

Two turnkey, beam-steered galvo laser systems from Preco Industries are designed for excising and ablating polymers, adhesives, and polyamides. Both systems cut complex shapes while maintaining a high level of accuracy. They perform the same functions as a typical die-cutting press, but without the turnaround time and expense of traditional hard tooling.

The PLG-15 from Preco Industries is suitable for rapid prototyping and production runs.

The PLG-15 is a sealed high-speed CO2 laser system that achieves speeds up to 40 in./sec. It is designed for cutting, ablating, marking, and drilling intricate geometries in a variety of materials including plastics, adhesives, ceramic, and glass. The system is capable of clean cutting polyamide materials with no carbon residue. Applications include processing of flex circuits, membrane switches, graphic overlays, gaskets, and labels. The machine features a working area of 20 x 20 in.

The PL355-15 is a solid-state diode-pumped UV laser system for excising, micromachining, and ablating thin metallic foils, polyamides, and other nonmetallic materials. It can excise and trim polyamide flexible circuits from base matrices without burning or leaving carbon residue on the parts or substrate. The short-wavelength laser operates in a photo-ablative process that can cleanly cut and kiss-cut polyamide base materials, copper circuit traces, and other conductive films and inks with no photo masks or hazardous gases.

The PLG-15 and PL355-15 have an accuracy and repeatability of ±0.004 and ±0.001 in., respectively, depending on the field size. CCD x-y-theta registration enables scaling based on fiducials. As the material stretches or shrinks during processing, laser geometry can be scaled in relation to actual fiducial separations. The systems come standard with a manual sheet feed tray. Options include an automatic conveyor system and a semiautomatic, rotary indexing, load-unload station. An optional web-handling system provides unwind and rewind of the substrate and matrix stripping and rewind for the scrap. The Windows NT-based touch screen controls facilitate setup and operation, and a job-memory storage function allows quick repeat setups.

End-pumped single-mode laser offers high beam quality with short pulse lengths

Available from Rofin-Baasel, the PowerLine E is capable of photo-quality marking on a variety of materials.

A short-pulse laser marker operates in a high brightness mode, making it suitable for applications involving metals, plastics, ceramics, and other composite metals. The PowerLine E from Rofin-Baasel Inc. is capable of sophisticated operations such as photo-quality marking. It features a small footprint for easy integration into a variety of new or existing machine concepts. Standard operating features available in the Windows-based VLM software allow different intensities from pulse to pulse for marking gray-scale bitmaps. The system's diode technology is designed for long life and minimal maintenance. Its cabinetry is IP54 compliant for use in industrial environments without concerns over long-term environmental degradation of its performance. The resonator measures 45 cm in length, and the unit offers a high peak power for short marking time.

Diode-pumped solid-state module can be incorporated into new or existing laser systems

The RG-series pump module, from Cutting Edge Optronics Inc., offers greater reliability and performance than traditional lamp-based laser technologies.

A continuous-wave diode-pumped solid-state module is designed to provide reliability and efficiency when incorporated into industrial and scientific laser systems. The RG-series pump module from Cutting Edge Optronics Inc. can deliver more than 750 W of continuous-wave power at 1064 nm. It is suited to serve as the core of a multikilowatt laser system. The laser module head pumps an Nd:YAG laser rod by radial arrays of coupled, long-lifetime laser diode bars to deliver pump uniformity and stable lensing performance. It is cooled by recirculating filtered water from a simple chiller system.

Pulsed Nd:YAG lasers enable controlled precision welding

The A-series lasers from Unitek Miyachi Corp. were designed to meet the strict requirements of medical device welding.

A line of pulsed Nd:YAG lasers was designed specifically to meet the demands of precision welding of medical devices. Available from Unitek Miyachi Corp., the A-series lasers offer a 5-70-W average output and branch balance stability. They feature power ramp-up and ramp-down tapering that improves seam welding quality by preventing under- and overheating at the beginning and end portions of the seam.

Real-time power feedback ensures pulse-to-pulse energy stability. Laser pulses are programmed in peak watts or joules that automatically compensate for flashlamp degradation, temperature variations, and power changes.

Pulse shaping, ordinarily only available in higher-power models, optimizes welding schedules for a variety of materials and produces deep penetration welds with low splatter. It also helps to eliminate cracking in otherwise difficult-to-weld materials. With up to 20 programmable segments, including steps and ramps, the lasers provide flexibility in tailoring the weld pulse to meet a variety of process requirements and extend the range of materials, platings, and joint designs that can be successfully welded.

The A-series 5-, 15-, and 25-W models are air cooled and feature up to three shared energy or time outputs. The 50- and 70-W models are capable of 50- and 70-J pulses, respectively. They are water cooled as standard, but can be ordered with an air-cooling kit that allows operation at reduced average power levels. The 50- and 70-W models can be configured with up to four shared energy outputs, up to six shared time outputs, or a combination of time and energy output configurations, allowing one laser to support multiple weld workstations.

Laser marker combines stable power with high-resolution graphics capabilities

An updated diode-pumped laser system incorporates a 10-W Nd:YVO4 laser source while maintaining high-resolution graphics capabilities. The LE-100S from RMI Laser Division includes a sealed laser head that uses fewer critical components than previous models for more efficiency and reliability. The pump diode can provide stable power for up to 10,000 hours, eliminating the need for costly and time-consuming lamp replacement. The system is powered by a standard 110-V-ac wall plug without an external heat exchanger. SymbolWriter software can convert most scanned images or Windows-based graphics into clear marked images on a range of materials. Many traditional bar codes and 2-D machine-readable codes are also supported. A microprocessor-based controller provides automatic system diagnostics and a built-in interface that enables the laser to be remotely operated from an industrial terminal or PC-based computer. Applications include marking texts, graphics, bar codes, and data matrices on various metals and plastics.

Laser production system incorporates CO2 and Nd:YAG laser formats

Offered by Online Inc., the SL-4848 is a versatile, modular solution for laser engraving and cutting applications.

A new laser system is suited for engraving and cutting machines. The SL-4848 Combo system, offered by Online Inc., can be provided with a CO2 and an Nd:YAG laser for processing a wide variety of materials. Along with integrated CNC-type control, the system features a simple property window that allows the user to set speeds, laser power, gas assist, and offsets for quick changeover when running different types of material. The 48 x 48-in. table is elevated with four leadscrews and 1½-in.-diam hardened shafting for stable, precise control and automatic focus adjustment. The SL-4848 features machine-tool quality construction including hardened ground rails and brushless programmable motors that are mounted on a rigid box frame construction and fastened to a heavy-duty welded tubular steel base. The automated sloped front opening provides easy access from the front or top. An integrated vacuum-fume extraction table is equipped with four individual shut-off valves for disabling any combination of sections when they are not required. The embedded control system does not require a PC for programming or operation. Additional inputs and outputs are included for controlling peripheral equipment such as conveyors and rotary dials without the use of an external PLC.

Compact excimer laser is portable, yet powerful

A self-contained excimer laser is available in 157-, 193-, 248-, 308-, and 351-nm wavelengths. The Optex from Lambda Physik Inc. has a 60 x 40 x 30-cm footprint, offers up to 22 mJ per pulse, and provides an up to 200-Hz repetition rate. It is designed to achieve precise results in a range of processes in clinical, laboratory, field, and factory settings. Application areas include dermatology, ophthalmology, photochemistry, and surface analysis. The laser is suitable for micromachining and microstructuring. It features Windows-based software, air cooling, single-phase connection, and the choice between serial RS-232 and DLL interfaces for 16- and 32-bit applications. Options include fiber-optic coupling and an application-programming interface. The company's NovaTube technology reduces component corrosion and contamination. Gas and tube lifetimes are increased while operating costs, downtime, and maintenance are reduced.

Katherine Sweeny

Copyright ©2001 Medical Product Manufacturing News

Feed System at the Heart of Pacemaker Production

Originally Published MPMN November 2001

PROFILE

Feed System at the Heart of Pacemaker Production

Equipment reduces vibration to enhance productivity and accuracy

The Mini-Rhinobar feed system from Lexair uses hydrodynamic force to improve bar stock stability and decrease noise levels even at high speeds.

The production of pacemakers, defibrillators, and dental implants requires many small, intricately machined components. For manufacturer MedSource Technologies Inc. (Minneapolis), most of these parts begin as 1/8-in.-diam stock that it machines down to finished products with diameters of 0.030–0.090 in., tolerances of ±0.0001 in., and finishes averaging 32 rms. Today, the company can easily achieve these exacting specifications, but when production first commenced, it ran into a significant problem. Although the firm was able to produce the required parts using its existing equipment, it had difficulty maintaining acceptable production speeds.

After some investigation, MedSource determined that the problem was caused by the gravity feed systems used to supply stock to each of the CNC turning machines and lathes. "With that kind of system, you reach a certain rpm and the bar starts whipping around," explains first operations foreman Dave Thomas. "That inhibits your ability to hold tight tolerances and finishes." The firm approached Lexair Inc. (Lexington, KY) to see if adopting its Mini-Rhinobar hydrodynamic bar feeder might offer a solution.

The Mini-Rhinobar feeder is a single-tube feeding system that uses oil to improve bar stock stability and reduce noise levels. The liquid fills the gap between the bar stock and the feed tube, using hydrodynamic force to center the material as it rotates. As the rotation speed of the bar stock increases, so does the magnitude of this centering force. A front swing-out mechanism with a large barrel clamp helps to further reduce vibration. Each Mini-Rhinobar system can accommodate as many as 16 feed tubes with diameters of 1/8-1 5/8-in and lengths of 6 or 12 ft.

MedSource installed 30 of the Mini-Rhinobar systems over a 2-year period and has noticed dramatic increases in productivity. "The primary benefit that we saw after installing the bar feeders was the stock stability it provided our CNC machines equipped with rotary guide bushings," says Thomas. "The rotary bushing on the machine rotates with the bar, allowing us to increase the rpm, which, of course, increases productivity." Thomas estimates that after installation, operators were able to improve the speed of some of the Swiss machines by as much as 50%, and 30% on average. Overall productivity was said to increase 20%.

MedSource Technologies machined these complex parts quickly using a Swiss CNC turning center equipped with one of Lexair's Mini-Rhinobar bar feeders.

But reducing vibration and noise are not the feeding system's only benefits. The unit also features an end-of-bar signal and an automatic retraction feature that allow unattended operation. Bar changeover time is estimated at 3 minutes. The equipment is sized for use in both large and small shops; the model employed by MedSource has a length of 17 ft. While not negligible, the required room is justified, says Thomas. "The floor space that they require is simply an issue that has to be planned in advance."

MedSource says it will continue to use Mini-Rhinobar feed systems in the future. With services spanning prototyping to full production runs, the company can machine complex components with microminiature to 1-in. diameters from stainless steel, titanium, platinum, MP35N alloy, and other materials.

Zachary Turke

Copyright ©2001 Medical Product Manufacturing News

Bar Code System Increases Throughput, Satisfies Validation Requirements

Originally Published MPMN November 2001

PROFILE

Bar Code System Increases Throughput, Satisfies Validation Requirements

Features include real-time error messages

Scanning the bar code attached to the mold produces a product-specific bar code label that also serves as the seal for each individually bagged part.

Injection molding plastic parts for the medical industry typically requires more-stringent manufacturing processes than are customary in other markets. Parts produced for the healthcare industry must submit to a rigorous validation process to ensure that they meet FDA regulations. Custom injection molder and contract manufacturer Nypro Inc. (Clinton, MA) is no stranger to these exacting standards; it has been producing blood diagnostic units, intravenous check valves, and contact molds for years. But in 1999, the company realized it had a problem. The validation system it was using was slowing production rates and was not Y2K compliant.

Company officials soon recognized that money could resolve the system's noncompliance, but nothing could be done to increase its speed. "Machine operators were waiting up to 5 minutes to generate a label," says Nypro project engineer Jim Rogers. "And if somebody scanned the same serial number twice or scanned the wrong thing, it would take them forever to get the error message." The company needed a system that could handle these complex transactions in real time with zero fault tolerance. After looking at several vendors, Nypro turned to Intermec Technologies Corp. (Everett, WA).

An operator scans bagged parts to cross-reference lot and cavity information.

Intermec proposed a bar code scanning workstation consisting of the company's Model 6540 computer terminal, a Model 7421 bar code label printer, and a Model 1800 CCD scanning device. As medical parts come off the production line, an operator bags them individually and scans a bar code attached to the mold. This scanning prompts the printer to generate a label based on that particular mold. This label is then scanned itself and used as a seal to close the bag. Scanning the bag's bar code prompts the system to verify mold cavity information and cross-reference previous scans to validate lot and cavity numbers. If the operator forgets to scan or scans the same label twice, the system produces an audible error signal.

Nypro installed these workstations on each of its 65 injection molding machines and has been pleased with the results. Not only did the company achieve regulatory compliance, but the system is roughly eight times faster than its predecessor. "Generating a label now takes only seconds," explains Rogers, "and operators are getting error messages in real time." Because each validation system also operates independently, a malfunction in one unit does not affect the rest. Nypro is so pleased with the workstations that it plans to install an Intermec wireless data-capture system in its warehouse in the near future. "None of our competitors has anything like it," concludes Rogers. "We are capable of doing things for bar coding right now that no one else can."

Zachary Turke

Copyright ©2001 Medical Producut Manufacturing News

Spotlight on Pumps and Valves

Originally Published MPMN November 2001

Spotlight on Pumps and Valves

Teflon diaphragm valves

Pneumatically operated Teflon diaphragm valves have 0.25- to 2-in. spigot connections for high-purity applications. The BSD-series units have no metals or elastomers in contact with process liquid, and weigh as little as 5 oz. The valves permit up to 100-psi inlet pressures and up to 25-psi back pressures. Plast-O-Matic Valves Inc., 1384 Pompton Ave., Ste. B, Cedar Grove, NJ 07009.


Computer-controlled peristaltic pump

A peristaltic pump maintains sterility in handling advanced live-cell pharmaceutical and biotechnological products that cannot survive valve transition or contact with stainless steel. The PD121 pump head uses a spring-loaded tube bridge that gently handles shear-sensitive products such as blood, tissue, or live cultures. The pump allows the filling of fluid products with volumes that range from 100 µl to 5 L with a ±0.5% accuracy. Flexicon Liquid Filling Inc., 115 Rte. 46 W., Ste. F1000, Mountain Lakes, NJ 07046.


Check valves

A company offers one-way back-check valves with barbed and straight fittings in a variety of sizes. Valves open at less than 2.5 in. of water and are tested to ensure that backflow does not occur even at very low back pressure. They are constructed of medical-grade acrylic and silicone. Miniature valves with male and female luer ends are also offered. Resenex Corp., 9614-F Cozycroft Ave., Chatsworth, CA 91311.


Silicone-dispensing valve

A valve features a retracting spool design that snaps off the flow of silicone at the needle or nozzle to ensure that accurate deposits are dispensed without stringing or waste. The 790HPNM can be integrated into an automatic dispensing robot or used as a benchtop dispensing system. I & J Fisnar Inc., 2-07 Banta Pl., Fair Lawn, NJ 07410.


Miniature diaphragm pump

A miniature diaphragm pump offers free flows up to 35 L/min with a peak pressure of 20 psi. The T2-01 pump offers 12-30-W power consumption over the operating range. Optional multihead configurations are available to achieve free-flow rates in excess of 120 L/min. Several motor, size, performance, and cost options are available to meet application specifications. The pump measures 5.25 x 2.75 x 3.875 in., and weighs less than 2 lb. It is suitable for portable air and gas applications where dc operation, low power consumption, minimal weight, and compact size are critical. The use of engineered thermoplastics provides light weight and corrosion resistance. T Squared Pumps, 1-E Frassetto Way, Lincoln Park, NJ 07035.


Latching solenoid valve

A subminiature latching solenoid valve is designed for applications that require ultralow power, low heat, and small size, such as battery-powered pneumatic instruments. The valve is magnetically latched and requires 10-millisecond pulses of current to switch its state. It consumes 2.8 mW·s per switch and offers bistable performance. Available in flexible plug-in, ported, and face-mount configurations, the valve measures 1.12 in. long x 0.28 in. diam. The Lee Co., 2 Pettipaug Rd., P.O. Box 424, Westbrook, CT 06498.


Industrial diaphragm pumps

A line of hydraulically balanced industrial diaphragm pumps can be close-coupled to 5/8 NEMA or metric motors, as well as belt-driven. The M-03-series pumps are self-priming, can run dry without damage, and are suitable for pumping clean fluids, nonlubricating fluids, abrasive solutions, caustics, corrosives, high-temperature fluids, and other liquids. Wanner Engineering Inc., 1204 Chestnut Ave., Minneapolis, MN 55403.


Type 343 ball valve

A Type 343 ball valve features a three-way true union design in PVC with sizes ranging from 2½ to 6 in. Available with socket, threaded, and metric fusion end connections, the valve offers an integrated universal mounting system. The three-way diverter ball provides interconnection of two inlets with an outlet for mixing, or interconnection of outlets for proportional diverter operation. George Fischer Inc., 2882 Dow Ave., Tustin, CA 92780.


Digital fluid motion system

A digital fluid motion system offers fluid metering, start-and-stop dispensing, and continuous low-pulsating delivery. The Travcyl delivers a ±0.1% absolute accuracy, symmetric performance in both directions, and no leakage at up to 100-psi pressure differential. With inert wetted parts, no valves, and clean-in-place capabilities, the system is suitable for medical, pharmaceutical, and biotech applications. Encynova International Inc., 557 C Burbank St., Broomfield, CO 80020.


Custom manifold systems

A company provides custom manifold systems that eliminate the need for tubing between valves, minimize internal flow volumes, reduce labor costs, and improve reliability. Available materials include aluminum, PEEK, polycarbonate, and polyethylene. Other materials are provided for specific toxicity, chemical resistance, and temperature requirements. South Bend Controls Inc., 1237 Northside Blvd., South Bend, IN 46615.


Low-cracking-pressure check valve

A miniature low-cracking-pressure check valve permits free flow in one direction and checked flow in the opposite direction. It operates reliably at less than 0.5 psi and is offered in a variety of combinations of 10-32 UNF external and internal threads. A captured O-ring gland ensures leaktight operation. Beswick Engineering Company, Inc., 284 Ocean Rd., Greenland, NH 03840.


Gear pumps

A series of gear pumps offers 0.5-gpm maximum flow rates, 200-psi maximum pressure, and 180°F maximum fluidic temperature capabilities. Three different sizes of PPS polymer gears are available on the 1000-series pumps, depending on flow rate and pressure requirements. Motors are thermally protected and reversible, and can run on either 12 or 24 V dc. Applications include metering, dispensing, or transferal of fluids. Gorman-Rupp Industries, 180 Hines Ave., Bellville, OH 44813.


High-flow check valves

A high-flow check valve has a disk with a short stroke as its only moving part. The disk-type check valve is available in 1/8-, 1/4-, and 3/8-in. sizes. It can be made of brass or stainless steel, and is suitable for use with liquids or gases. Fixed flow control allows free flow to occur in one direction and metered flow to occur in the opposite direction. O'Keefe Controls Co., 4 Maple Dr., Monroe, CT 06468.

Copyright ©2001 Medical Product Manufacturing News

Display Allows Wide-Angle Stereoscopic Viewing

Originally Published MPMN November 2001

HOTLINE

Display Allows Wide-Angle Stereoscopic Viewing

Viewers do not need special eyewear

The SynthaGram from Stereographics Corp. allows the viewing of stereographic images without extra eyewear.

An autostereoscopic display provides wide viewing angles, allowing several engineers to view images at the same time. Developed by Stereographics Corp. (San Rafael, CA), the SynthaGram monitor provides realistic viewing of complex 3-D computer graphics without the need to don special eyewear. The Stereo3D technology's true-depth depiction reduces the amount of time engineers and scientists spend on graphical data interpretation and improves comprehension of data. "As flat-panel displays become more prevalent, we offer a stereoscopic visualization solution that will provide a realistic viewing experience," says founder and chief technology officer Lenny Lipton.

The SynthaGram is supported by Windows ME/2000/NT/98 operating systems. The monitor includes an LCD panel, a lenticular screen, a viewer to play back stereo images, a graphics card with a digital output adapter, and software plug-ins that enable the creation of autostereographic images on existing graphics programs. A software developer's kit includes an application-programming interface that supplies tools necessary to create software that supports autostereoscopic displays. Applications include virtual prototyping and medical imaging.

Katherine Sweeny

StereoGraphics Corp., 2171 E. Francisco Blvd., San Rafael, CA 94901; Phone: 800/783-2660; Fax: 415/459-3020; www.stereographics.com


Nd:YAG Lasers Mark without Chemicals

Systems precisely mark at high speeds

The Violino laser system from Gold International Machinery Corp. features a long-life diode.

A diode with an average life of 10,000 –15,000 working hours is the only consumable in a company's CW and Q-switched Nd:YAG solid-state lasers. Developed by Gold International Machinery Corp., LaserGold Div. (Pawtucket, RI), the lasers come in 5-, 10-, and 20-W models at up to 1064 nm. The Violino laser systems offer end pumping and optical reshaping technologies that deliver 30–40% output efficiency, beam quality, and the stability needed for precision marking on plastics and other materials. They are air-cooled, do not require an extra chiller, and come with Windows NT laser marking software. Focused into the fiber optics, the laser spot size measures 20–50 µm diam depending on the focal lens. Sealed in a Class 1000 cleanroom, the resonator is impervious to dust and humidity, preventing destruction of the crystal and misalignment of mirrors. The laser requires no chemical treatment to mark plastics or metals, and the diode source has replaced disposable flash lamps to reduce maintenance. Marking rates can go as high as 1500 mm/sec without sacrificing mark quality.

The units are no larger than a PC tower and can be integrated into production lines. Additional available wavelengths include 355, 532, 808, and 940 nm for applications such as soldering, microcutting, and microdrilling. The Violino lasers were "developed to address the increasing need in precision manufacturing for marking to trace and identify manufactured goods quickly, without chemicals or inks," says executive vice president Joshua Gold.

Katherine Sweeney

Gold International Machinery Corp., LaserGold Div., P.O. Box 998, Pawtucket, RI 02862-0998; Phone: 401/724-3200; Fax: 401/724-6310; www.goldmachinery.com


Ergonomic Pipette Eases User Strain

Device enables fluid transfer with reduced gripping force

The Ovation BioNatural pipette from VistaLab Technologies reduces the incidence of repetitive strain disorders by lowering hand position and minimizing muscular movement.

Conforming to the shape of a user's hand, a pipette from VistaLab Technologies (Pleasantville, NY) reduces strain by enabling fluid transfer to be performed with a natural posture and minimal muscular movement. "Pipetting is the primary cause of musculoskeletal injury in labs," explains spokesperson Michael Wagner. "Common injuries that can result from the process include carpal tunnel syndrome, tendinitis, epicondylitis, and trigger finger." The Ovation BioNatural pipette reduces the occurrence of these ailments by lowering the required hand position and relaxing the wrist angle. Because the product fits naturally in the hand, the amount of gripping force needed to hold the product is also reduced.

The Ovation BioNatural pipette is suited for dispensing liquids in volumes of 0.2 µl to 1 ml, and stores up to five user-defined volume settings for quick changeover. Aspiration, dispensing, and other functions are performed using a low-force plunger and release button. The unit produces an audible click when a tip is properly fitted, and discards it automatically at the push of a button. Other benefits include bright coloration to ease identification and the tool's ability to stand without the aid of a rack or holder.

Zachary Turke

VistaLab Technologies, 270 Marble Ave., Pleasantville, NY 10570; Phone: 888/652-6520 or 914/749-8700; Fax: 914/749-8705; www.mlasystems.com/html/nf/home.html



Medical Product Manufacturing News
is always on the lookout for innovative products and services. If you are aware of any that have recently been or are about to be introduced, please call the Hotline editor, at 310/445-4265.

Copyright ©2001 Medical Product Manufacturing News

Injection Molding Process Developed for High-Consistency Rubber

Originally Published MPMN November 2001

INDUSTRY NEWS

Injection Molding Process Developed for High-Consistency Rubber

High-consistency rubber can be injection molded using a specialized process developed by Molded Rubber & Plastic Corp.

Equipment designers can now specify the use of high-consistency rubber in their injection-molded products through the use of a specialized injection molding process developed by Molded Rubber & Plastic Corp. (Butler, WI; www.mrpcorp.com). Called injection transfer molding (ITM), the process brings the cost, cycle times, and processing consistency associated with liquid silicone rubber to the molding of high-consistency rubber with its modifiable physical properties. "The ITM process has several benefits over previous methods used to process high-consistency rubber," says marketing and sales vice president Scott Pakenham. "It allows better injection control and incorporates a cold-pot method that minimizes material waste." Vacuum pressure used to pull air out of the tool and to eliminate flash is also cited as a benefit.

Suitable products for ITM include high-volume disposable parts that require inertness, clarity, and recoverability. The process can be used to produce deep and drawn parts, but this may require the use of rotating brushes to ensure demolding. The company also offers traditional liquid silicone rubber injection molding services.

Zachary Turke

Copyright ©2001 Medical Product Manufacturing News

Medical Carts Win IDEA Awards

Originally Published MPMN November 2001

INDUSTRY NEWS

Medical Carts Win IDEA Awards

The Arrow stand, designed by Modo Inc., supports a noninvasive diagnostic system for cardiology. The unit puts everything the doctor needs for the procedure within easy reach, and the system can be custom configured.

Modo Inc. (Portland, OR; www.modocarts.com) received two awards for its medical carts in the 22nd annual Industrial Design Excellence Awards (IDEA) competition. The company won a silver award in the medical and scientific products category for its Arrow roll stand, which was designed for Arrow International (Reading, PA), a maker of cardiac-care products. Modo also took home a bronze prize in the competition's furniture category for a roll stand created for Rich-Mar (Inola, OK), a designer and manufacturer of therapeutic ultrasound systems.

"For both Arrow and Rich-Mar, our goal was to make sophisticated medical technology more approachable and easier to use," says Glenn Polinsky, director of design at Modo. "We wanted to create products that would support our customers' devices as well as the activities that surround the devices."

The Arrow stand organizes a cardiac-instrument probe, disposables, and technical documentation into a package that is easy to use and move. All of these elements used in a noninvasive cardiac procedure are arranged in logical hierarchy that reflects the way cardiologists work.

"The design of the cart captures the simplicity and innovation of our technology," says Jean-Luc Boulnois, PhD, of Arrow International. "It puts everything at the doctor's fingertips."

The Rich-Mar roll stand supports a therapeutic ultrasound device for sports medicine and physical therapy in doctors' offices, clinics, and hospitals.

The Rich-Mar roll stand for therapeutic ultrasound machines incorporates oversized casters that make it responsive, easy to control, and capable of negotiating obstacles such as uneven elevator thresholds. Wings on either side of the unit are designed to serve as a resting place for the ultrasound handpiece. A cable on the rear spine makes transport safe and easy for power cable storage.

Both carts measure 32 x 16 x 18 in. and weigh 50 lb. The vertical spine on the Arrow model is made of extruded aluminum and the frame of the Rich-Mar is made from steel tubing. Both feature a heat-cured epoxy finish.

The support arm and handle on the Arrow are cast aluminum and its legs are fabricated from laser-cut steel. The probe holder is made of machined nylon, while the casters are injection-molded nylon.

Legs on the Rich-Mar are laser cut, ¼-in. aluminum sheet. The unit features bins that are made of fabricated steel sheet and casters made of injection-molded nylon.

The IDEA competition is sponsored by BusinessWeek and the Industrial Designers Society of America.

Susan Wallace

Copyright ©2001 Medical Product Manufacturing News

Biomimetic Silicones Take a Cue from Nature

Originally Published MPMN November 2001

INDUSTRY NEWS

Biomimetic Silicones Take a Cue from Nature

A team led by a professor at Queen's University Belfast (Northern Ireland) has developed a patented technology for the production of biomimetic silicone materials that can imitate the body's natural defense mechanisms.

With a coefficient of friction approaching zero, the silicone materials are highly lubricious. This property should enable their easy insertion and removal without pain or tissue trauma, says Sean Gorman, who is chair of the pharmaceutical microbiology department and head of the school of pharmacy at Queen's University. Gorman also heads up the school's medical devices group.

Another innovative feature of the silicones is that they are self-cleaning. Like the body's epithelial tissues, the materials can fight adhesion through the shedding and renewal of their surfaces. The silicones, which can be created at varying levels of hardness, can be processed using conventional methods and can withstand gamma irradiation.

The technology used to produce the materials relies on the use of higher-molecular-weight polysilanes as crosslinking agents for silicones. Gorman describes the chemical mechanism underlying the materials' increased lubricity using an analogy from nature. "It's like what might happen if you tried to hold a fish in your hand. It's a slippery surface that has been designed by evolution to prevent adhesion," he says. "We see our materials as offering this same characteristic by taking a lesson from evolution," he adds.

In addition, the enhanced lubricity of the silicones holds promise as a platform for drug delivery. Gorman notes that the materials can be tailored to deliver an active agent over a specific course of time, from days to months.

Gorman has formed a company, Xiomateria Ltd., to develop the materials. The enterprise, which is based at the university, will not manufacture products itself, but is seeking to license its technology to third parties. The company is currently in negotiations with a U.S. manufacturer.

According to Gorman, a further advantage of the new materials is that they do not present any substantive alterations from the RTV silicones currently used in medical devices. "They are made in the same manner, and there is no downside as far as cost is concerned," he says. Furthermore, he notes, they are "every bit as biocompatible as their parent substance."

Looking beyond the new silicones, Gorman makes both a technical and a philosophical case for a biomimetic approach to materials engineering. "Materials should mimic nature," he says. "It is arrogant for us as biomaterial engineers to assume that we can provide a replacement for a urethra or a vein by manufacturing a device from a single material." He adds that his team's approach has been "to combine the structural engineering in current device technology with new materials that offer the benefits of evolution."

Benjamin Lichtman

Copyright ©2001 Medical Product Manufacturing News

Code Blue Communications Brings Bluetooth to Medical Markets

Originally Published MPMN November 2001

INDUSTRY NEWS

Code Blue Communications Brings Bluetooth to Medical Markets

Code Blue Communications Inc. will distribute this serial port adapter and other Bluetooth products manufactured by connectBlue.

An interface device developer has gained exclusive rights to distribute connectBlue (Malmö, Sweden; www.connectblue.se) Bluetooth products to the North American medical industry. Specializing in the development of integrated solutions for healthcare markets, Code Blue Communications Inc. (Seattle; www.codebluecommunications.com) is adding these products to its own line of devices that eliminate the need for electronic cables. The Bluetooth products are suited for battery-operated devices and offer many advantages, including an operating range of 10 m. "These products have low power requirements and ease the establishment of piconets [a network of devices using Bluetooth technology]," adds Code Blue Communications' president Bill Saltzstein. Some possible medical applications include portable monitors and infusion pumps.

According to company principals, the partnership between the two organizations is mutually beneficial. The medical device industry "is an untapped market in terms of Bluetooth implementations," says connectBlue president Rolf Nilson, "largely due to the lack of specialized knowledge among the Bluetooth community about the industry's requirements. Code Blue Communications has this specialized knowledge of the issues unique to the medical market." In return for this knowledge, Code Blue Communications gains access to the Swedish company's proven technology. "ConnectBlue's products have already been used successfully in industrial applications that require many of the same mission-critical performance standards as medical devices," says Saltzstein.

Zachary Turke

Copyright ©2001 Medical Product Manufacturing News