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Articles from 2005 In January


Passing the Test

Originally Published MPMN January 2005

PRODUCT UPDATE

Passing the Test

Inspection and monitoring processes improve with new technology and expanded services

Corinne Litchfield
Radial expansion force equipment from Machine Solutions Inc. measures a stent’s hoop force using segmental compression.


During the product development process, medical device manufacturers must conduct testing in order to evaluate safety and performance. Monitoring exposure to gases used in the medical device industry, such as during sterilization and validation procedures, may also be necessary. This article discusses the latest news from testing facilities, as well as machinery and products available for package and product testing.

Expansion of Testing Services Builds on Existing Relationships with Customers

An increase in customer requests and the company’s knowledge of the testing industry drove the decision by DDL (Eden Prairie, MN) to recently expand its product test engineering team as well as its testing facilities. “We can now not only test the package, but the product inside as well,” says CEO John Hart.

Already known for its package-testing services, the company is building on its reputation with existing customers. “We expect this to be a significant new area of business,” says Hart.

Established in 1990 as a package- testing company, DDL quickly grew to include materials testing of polymers, elastomerics, and synthetics. Over the past year, the company saw more requests for testing of catheters, implantables, and other medical devices, making the expansion into product- testing capabilities a logical step forward.

While product-testing services will initially be available only through its Eden Prairie location, the company plans to expand such services to its California facility.

Stent-Testing Equipment Eliminates Test Variability

Hoop force is the outward force originating at the center of a tube and is equal in all directions. In the case of balloon-expandable stents, it is the force that the stent exerts on a blood vessel. For self-expanding stents, it is the force that the stent applies while it expands. FDA requires hoop force testing prior to product approval, yet there is no established standard for testing. Some commonly used methods include a tape method that incorporates radial compression and friction, flat plates that bend the stent at two points, and v-blocks that bend the stent at four different locations. None of these methods is ideal. Both the flat plate and v-block methods do not test radial compression, an important factor in evaluating stent hoop force, and the tape method uses a piece of fabric that is subject to environmental variables.

The video polarimeter system from Strainoptics Inc. inspects stress and strain patterns in
plastic products.

However, a new device might solve these problems. Machine Solutions Inc. (Flagstaff, AZ) aims to make its RX500 radial expansion force gauge the new industry standard. The RX500 uses a 12-point segmental compression system. It is controlled by a microstepping linear actuator designed to provide a low-friction testing environment. With reduced friction levels, the equipment eliminates the test variability and measures product variability. “The RX500 provides much more accurate and repeatable test results,” says Melissa Lachowitzer, product testing division manager.

All electronics and workings are separate from the machine’s testing head, which can be removed for heating or cooling. The calibration process is simple and the equipment requires little maintenance.

Machine Solutions also offers torque-testing equipment and contract testing services. In keeping with its goal of automating or semiautomating processes in catheter and stent manufacturing, the company plans to launch stent-dislodgement equipment in the future.

Package Seal Testing Delivers the Goods

Preserving the sterility and integrity of packaged biomedical products is necessary, yet many testing methods can damage the packaging, seal, or contents. A new line of noninvasive oxygen measurement systems from OxySense Inc. (Dallas) allows manufacturers to assess oxygen levels within containers, bottles, and packages without puncturing or destroying the seal. The OxySense 4000 is fully portable and self-contained, with an integrated 8.4-in. display, built-in processor, and automatic infrared temperature sensor. The 200T model attaches directly to a laptop or PC. Applications include oxygen permeation studies for packaging of sterilized medical devices and anaerobic testing in sealed containers.

Hawo GmbH (Obrigheim, Germany) offers Seal Check test strips for evaluating packaging seals. Designed for daily testing of the company’s continuous sealer machines, the products use an indicator strip to show whether there are punctures or tears, material delamination or separation, channels, or open seals. Any deviations in the machine’s sealing temperature or pressure are visible on the strip. When used on a daily basis, Seal Check strips can ensure that the sealing device is working correctly and at optimum efficiency. If the sealer machine has an integrated Seal Check function, the critical sealing parameters, test date, and tester name can be simultaneously printed on the reverse side of the test strip by an electronic printer.

Stress Patterns, Mechanical Properties Are Among Tests Conducted on Plastic Products

Materials testing of plastics and elastomers measures everything from strength to elasticity. The video polarimeter system from Strainoptics Inc. (North Wales, PA) enables rapid inspection of strain patterns in clear and translucent plastic products. The system consists of a high-precision, laboratory-quality polarimeter equipped with a color CCD video camera with 6–32¥ zoom magnification and a high-resolution color CCTV monitor. Unacceptable gradients of stress or strain are detected by measuring double refraction in the plastic being tested.

Hawo GmbH offers Seal Check test strips to monitor seal quality in the company’s continuous seal machines.

For the engineer needing to test mechanical and melt properties of various plastics, ATS Rheosystems (Bordentown, NJ) offers the Dynalyser rheometer. Designed for testing materials such as thermoplastics, thermosets, elastomers, semisolids, and fluid systems, the Dynalyser performs steady shear, transient, and dynamic oscillatory measurements using parallel plate, cone and plate, couette, rectangular torsion, dynamic tension, and other fixtures. The rheometer's true 32-bit, multitasking software is Windows-based and provides a convenient platform for instrument operation, data analysis, and system networking. The unit uses an environmental control system with an indirect heated and cooled oven that is equipped to test polymer melts, solids, and fluid materials. The oven’s heating element incorporates a circulation air flow for temperatures ranging from –180° to 550°C.

EtO Monitors Allow for Safer Sterilization Facilities

Prolonged exposure to ethylene oxide (EtO) used in sterilization processes can be hazardous to employee health. Two new products have been designed to detect and monitor EtO levels.

The EtO monitor from Assay Technology (Pleasanton, CA) can be used to document compliance with OSHA regulations. The monitor can be placed in an employee breathing zone to document exposure for either 8 hours or 15 minutes, then it is returned to the company’s laboratory, where a report of exposure levels is available within 6 working days.

EtO gas detectors from Kernco Instruments Company Inc. (El Paso, TX) feature adjustable set points and alarms. Designed for continuous monitoring of EtO levels, the sensor elements in the detectors are explosion-proof and rated for Class I Division I, Group A-B-C-D hazardous atmospheres. Readout ranges are given in either 0–10 or 0–100 ppm, and both visual and audible alarms are activated when the level has been exceeded.

Copyright ©2005 Medical Product Manufacturing News

Company Molds Handles for Medical Device OEMs

Originally Published MPMN January 2005

Outsourcing Outlook

Company Molds Handles for Medical Device OEMs

Manufacturer Expands Capabilities to Include Thermoformed 3-D Products

A manufacturer creates ergonomic silicone handles for use on a variety of medical devices. The handles are produced using a proprietary process that overmolds the silicone onto stainless-steel, aluminum, and high-performance plastic cores. The material used for the handles is a custom-blended formulation allowing for specific hardness, texture, and color requirements. No-play ratcheting drivers, torque-limiting and torque-measuring instruments, and standard shaft quick-locking connectors are among the instruments that use the handles. The company also offers custom instrument-handle development services. Rapid prototyping and on-line design reviews with customers hasten the development process on new handle shapes. Gauthier Biomedical, Grafton, WI www.gauthierbiomedical.com



Molder Provides Low-Volume Production Programs

Economical low-volume production programs for custom enclosures and bezels are available. Using aluminum and prehardened steel molds, the company produces molded enclosures that meet exact design specifications. Many materials and colors are available. Because there are no minimums on production orders, the service can be used for initial launches and into production. The tooling is guaranteed into the hundreds of thousands of pieces. Mold Threads Inc., Branford, CT www.moldthreads.com




Micromold Manufacturer Expands Capabilities

A high-precision micromold manufacturer has added microinjection molding capabilities, as well as turnkey micromolding systems. The company offers precision components with tight tolerances, including 0.5 ¥ 50-µm microfluidic slots, slots in sensors as small as 0.002 in., nozzle orifices as small as 0.0027 in. diam, and cannula and medical pouches with walls that are 0.0015-in. thick. By adding custom micromolding and custom-built turnkey micromolding systems to its capabilities, the company can provide single-source, plug-and-play solutions to medical device OEMs. Complex microscopic parts or microscopic design features on larger parts in devices such as catheters, microfluidic nozzles and chips, MEMS and microsensors, resorbable implants, electronics, and tiny industrial pumping mechanisms can be produced quickly. Miniature Tool & Die Inc., Charlton, MA www.miniaturetool.com


Engineered Resins and Insert Molding Are Among Company’s Specialties

A contract firm’s injection molding division offers custom design, tooling, and injection and insert molding of products for the medical device industry. Small- to medium-size runs and detailed insert molding are among the company’s specialties. Its in-house design department uses highly advanced three-dimensional software, a fully equipped mold-making shop, and current injection molding technology. Various engineering polymers are used, from thermoplastic elastomers to reinforced or filled resins. Shot sizes range from 1¼10 of a gram up to 80 oz. Hot stamping, ultrasonic welding, and packaging services are also available. Plastics One Inc., Roanoke, VA www.plastics1.com


Molding Facility Uses Aluminum Tooling

A manufacturing company specializes in custom injection molding of parts for use in a variety of applications. Its CAD/CAM tool room includes CNC, EDM, and conventional machinery. In addition to standard steel tooling, low-cost aluminum tooling is also offered. Engineers are available to assist customers with improving product design and function. ACI Medical Inc., San Marcos, CA www.acimedical.com


Tooling and Molding Process Supports Rapid Device Development

Injection molding tooling can be produced in 10 working days by a parts manufacturer. Quick turnaround times allow engineers to develop concepts and, once proven, proceed immediately to full production. The company’s molding process is capable of using any injection-moldable material, such as commodity resins, Ultem, and PEEK. The firm produces parts for medical device OEMs. Advanced Technology, Corona, CAwww.adv-tec.net


Contractor Offers Cleanroom Injection Molding

A full-service contract manufacturer offers high-precision custom molding in a certified Class 100,000 cleanroom. A variety of Class VI medical-grade, sterilizable materials provide thermal performance, strength, and durability. The company’s molding facility utilizes high-speed material-handling equipment and closed-loop processes to ensure products are molded in a controlled environment. Process controls are in place to allow for tight tolerances in a fully automatic cycle. Services include mold-tool design, build, and prototyping in conjunction with injection molding to maximize mold performance. Advanced Scientifics Inc., Millersburg, PA www.advancedscientifics.com


Custom Molder Produces Parts in Controlled Environments

A tubing supplier has introduced a total intermittent extrusion (TIE) process, enabling the continuous extrusion of rigid-to-soft catheters without bonding. Engineers can design catheters with a smooth transition point between polymers with hardness levels ranging from 75 D to 80 A. According to the company, TIE reduces breakage at the rigid-to-soft point compared with standard bonding technology. Suitable for use in applications that require a stiff shaft and flexible tip, the tubing is used in urology, radiology, neurology, and cardiology applications. TIE tubing is also available in multilumen form, composed of thermoplastic medical polymers. The level of radiopacifier can be customized to illuminate specific sections of tubing. Putnam Plastics Corp., Dayville, CT www.putnamplastics.com

Copyright ©2005 Medical Product Manufacturing News

Switches, Signals, and Connectors

Originally Published MPMN January 2005

SPOTLIGHT

Switches, Signals, and Connectors

Sensor for diagnostic technology

A supplier of switches and other products to the medical manufacturing industry performs all its prototyping in-house. The firm was approached by a company to be a part of the SuperStellate Array project and develop a sensor to be used in diagnostic technology. The firm adapted and reengineered the design of another company and created a printed circuit sensor that provides a quick, painless, and inexpensive method of detecting breast cancer. The arrays attach to the breast, and the hardware and software gather, analyze, and report the results. Golden Valley Products Inc., Minneapolis, MN www.gvp-inc.net



Miniature solderless connectors

Elastomeric cores are combined with fine-pitch conductors to form connectors featuring solderless assembly, a gasket-like seal, and multiple contacts. By using modular manufacturing techniques, the company wraps or embeds 50-µm-diam wires in rubber substrates according to customer requirements. The resulting parts can replace pogo pins or traditional metallic connectors. The compressing of the flexible substrates generates the force needed for attaining an electrical connection and also creates a seal. This force is achieved by employing threaded fasteners or snap-action designs. These mechanical features can be integrated with the final packaging, which may reduce manufacturing costs. Z-Axis, Warminster, PA www.zaxisconnector.com


Electronic connectors

A company develops and supplies a variety of interconnection products and electronic connectors such as precision cylindrical connectors, which are suitable for use in medical applications. A complete range of services are also provided, including application consultation, technical support, and custom development and design through final distribution.
Fischer Connectors Inc., Atlanta, GA www.fischerconnectors.com


Custom membrane applications

A manufacturer of membrane switches, graphic overlays, flat or formed RFI/EMI shielding, disposable biosensors, and electrochemical sensors offers laser-cut prototyping without high tooling costs. The ISO 9000:2001–certified firm provides services from the initial design through assembly, packaging, and final shipment. Custom designs are available. Conductive Technologies Inc., York, PA www.conductivetech.com







Disposable connector

A connector is suitable for use in a wide range of medical applications and is economical for one-time purposes. The Redel disposable connector series is compatible with the line’s 1P devices. EtO and gamma-radiation sterilizable, the units feature a new simplified latching mechanism and stamped contacts that are soldered, then snapped into place, enabling easy termination and eliminating cleaning. Available in four keyways, the connectors have removable snap-on back shells that allow for quick correction of assembly errors and are 100% scoop free. Lemo USA Inc., Rohnert Park, CA www.lemousa.com


Block headers

A company has added three new series of double-level, high-temperature, SMT-compatible printed circuit board terminal block headers to its line of products. Available in a wide range of pin spacing, the devices have low space requirements and high contact density. The MCD 0.5-HT has 2.5-mm pin spacing; the MCD 1.5-THT, 3.81 mm; and the MCDN 1.5-THT, 3.5 mm. The headers are offered in horizontal or vertical configurations with optional screw flanges or plastic locking latches. Parts can be easily integrated into surface-mount production processes, eliminating hand soldering. Phoenix Contact Inc., Harrisburg, PA www.phoenixcon.com


Sensor ring

A switch is suitable for medical scanning heads or patient-transport tables. Replacing multipiece multiswitches, the Sensor-Ring is used in applications that require sensing over a large curve or circle. A curved, one-piece, flexible sensing edge, located on the circumference of a hollow arc or ring, provides contact closure when touched at any point. This configuration enables wires, mechanical components, or personnel to pass through. Available in 1.5–5.0-ft diameters, the product can cover an angular range from 10° to 360° and meets protection classification IP67. Sensing can be installed on up to three sides of the ring. Tapeswitch Corp., Farmingdale, NY www.tapeswitch.com


Ac switch

Capable of being used in place of electromechanical relays, a three-pole ac switch combines three normally open solid-state relays in a single package. The HBC-065 can be wired as a three-pole, single-throw relay when inputs are tied parallel to each other or as three isolated single-pole, single-throw relays. The unit’s adaptability makes it suitable for solenoid switching; controlling pumps, heaters, and small motors; and other general-purpose, low-current switching applications. Measuring 1.5 ¥ 3 ¥ 1 ft, the device operates at an output of 12–280 V rms, with an output of 0.01–1.5 A rms per pole and a typical current of 15 mA per input. Its control voltage is 4–10 V dc with input impedance of 300 W. Featuring 0.25-ft faston terminals, the switch can be mounted on a panel or DIN rail. HBControls Inc., Fall River, MA www.hbcontrols.com


Touchproof connectors

An ISO 9001–certified company manufactures FDA-compliant 2-mm touchproof connectors, adapters, and leads. Low- and high-current connectors and test accessories as well as a complete line of potential equalization or equipotential grounding products made to DIN and IEC recommendations are among its other offerings. Custom manufacturing is available. Multi-Contact USA, Santa Rosa, CA www.multi-contact-usa.com


Power entry module

A power entry module is designed to save space as well as minimize time and cost during the assembly of electronic devices. The Series DC21 unit features an ac inlet and on and off switch functions that are internally wired and connect to a printed circuit board for three-pin installation, which minimizes emissions that result from the use of wire connections. The low-profile design eliminates the handling of wires, and a rear cover further insulates the module from other components. Available in one or two poles, the device has an in-rush rating of 100 A for 3 to 4 milliseconds or 5 A continuous, and its lifetime is rated for 50,000 cycles at 10 A and 250 V. The product features a lighted option for status indication and is also available in a model with an EMC filter that attenuates noise in common and differential modes. Schurter Inc., Santa Rosa, CA www.schurter.com

Copyright ©2005 Medical Product Manufacturing News

Adhesives

Originally Published MPMN January 2005

SPOTLIGHT

Adhesives

Pressure-sensitive tape adhesives

A company manufactures adhesives that are suitable for use in medical devices such as pressure-sensitive tapes. Nonwoven materials coated with these adhesives are strong yet easy to tear and can be flexible or rigid. The adhesives can also be used with films such as breathable polyethylenes and polyurethanes, foams that have qualities like those of polyethylene and polyurethane, and strong elastic and nonelastic woven fabrics. The products can be customized to customer specifications. Applications include wound dressings, tapes, surgical products, diagnostic devices, ostomy products, electrodes, and IV devices. Alpharma A/S, Vennesla, Norway www.norgesplaster.com


Two-component epoxy adhesive

A USP Class VI–compliant two-component epoxy adhesive can withstand repeated cycles of steam, ethylene oxide, radiation, and chemical sterilization. The EP62-1Med cures at temperatures ranging from 150° to 200°F and has a long working life at room temperature. It contains no solvents or volatiles and has a 100:10 mix ratio by weight. Capable of bonding to metals, glass, ceramics, wood, and most plastics, the adhesive is durable and serviceable up to 400°F. Shrinkage upon cure is less than 0.06%. The product is available in a variety of quantities as well as in gun applicators. Master Bond Inc., Hackensack, NJ www.masterbond.com



Adhesive laminates

A company offers foams, polyesters, polyurethanes, nonwovens, and a variety of other custom-coated pressure-sensitive adhesive laminates. Specialty laminates are contract manufactured under pharmaceutical GMP conditions and available to the medical device industry. The products can be made to customer specifications. LTS Corp., West Caldwell, NJ
www.ltslohmann.com



Dispensing systems

Easy-to-use, resealable dispensers such as small squeeze tubes and cart-mounted, automated systems preserve unused adhesives until the next application. Providing ratio control and safety, Dev-Tube dispensing cartridges hold 25 mm of two-component adhesive. The Mark 5 System accurately mixes as it dispenses resin and activator from the firm’s 50-ml cartridges, which fit into manual or pneumatic applicator guns. Larger dispensing guns accept 400-ml cartridges, and an automated meter-mix dispensing system can handle 5-gal pails or 55-gal drums. Adhesives can be customized according to color, open or fixture times, and cure speeds. Devcon, Danvers, MA www.devcon.com



Acrylic adhesive

A light-curable acrylic adhesive is used for bonding needles, syringes, and other stainless-steel cannulae to polycarbonate, PVC, and polypropylene hubs. Producing clear, high-strength bonds with minimal variation in tensile strength values, 1193-M-VLV has low viscosity for quick, air-free dispensing into needle-hub cavities. It can cure in less than a second when exposed to high-intensity UV light, making it suitable for high-speed, high-volume automated syringe assembly. The ISO 10993–compatible adhesive is suitable for use in elution, systemic injection, intracutaneous applications, implantation, and hemolysis. Dymax, Torrington CT www.dymax.com



UV-curable adhesive

A UV-curable, pressure-sensitive adhesive (PSA) offers the printing flexibility of an additive process. Electrodag PM-030 provides customers a printable PSA option without the problems associated with using solvent-based products. Providing a long pot life and an environmentally friendly, nonvolatile-organic-compound system, it allows printers to achieve high film build and fast processing speeds. Acheson Colloids Co., Port Huron, MI www.achesonindustries.com





Ostomy adhesives

A line of pH-balanced custom ostomy adhesives offers durability and peelability. The adhesives are individually formulated for a range of applications, including colostomy and ileostomy bags. Features of the adhesives include long tack and wear times even in wet applications, fluid stability, and low skin irritability. The level of adhesion to skin can be precisely controlled, and alginates are incorporated into the adhesives to stabilize the fluid-handling properties and provide sodium or calcium exchange. GriggSmith Industries, Richmond, IN www.griggsmith.com



Syringe barrels

Available in 3-, 5-, 10-, 30-, and 55-cm3 configurations, silicone-free syringe barrels are used with standard air-powered dispensers. The dark amber–colored devices protect a wide range of UV- and light-sensitive adhesives by blocking wavelengths between 240 and 550 nm. Their translucent design keeps adhesives from curing prematurely and allows users to monitor adhesive levels and check for bubbles. Double-wiper pistons prevent drips and eliminate waste by wiping syringe walls clean as the adhesive is dispensed. EFD Inc., East Providence, RI www.efd-inc.com/medical

Copyright ©2005 Medical Product Manufacturing News

Cuts Better Than a Knife

Originally Published MPMN January 2005

PROFILE

Cuts Better Than a Knife

Metal bellows seals out leaks in improved electric scalpel

Click to enlarge.

Electric-powered surgical instruments can perform miracles on patients, but not if they leak around the seals.

That is exactly the problem designers faced when prototyping an improved electrical scalpel. The idea was to move electrical control from foot pedals to push buttons right on the handpiece, giving surgeons greater control and sensitivity. The handpiece contained two control buttons. One was for high and low speed and the other controls multiple gripping positions.

Trouble was, the handpieces required autoclaving after each use, causing the rubber switch seals to leak. The seal design consisted of a rubber membrane over a dome-type snap switch, much like the switch
on today’s most popular electric toothbrushes. The arrangement on the handpiece prototype was leakproof at ambient temperature and pressure, but not at the typical heat-and-vacuum cycles of steam autoclaving.

Under vacuum, the membrane stretched and became porous due to the negative pressure gradient set up between the inside and outside of the handpiece. Then, as the vacuum was released, rising chamber pressure drove residual moisture through the seal, ruining the electrical contacts inside. In fact, rubber seals in the prototypes sprang leaks during the very first autoclaving cycle.

The solution was a metal bellows-type switch seal assembly from Servometer (Cedar Grove, NJ; www.servometer.com). Designers called Servometer to see if a metal bellows solution would work.Servometer then collaborated with the instrument maker on a redesign that solved the problem entirely. In fact, the handpieces are now good for thousands of use and autoclaving cycles.

Success of the redesign hinged on a “thumbtack-within-a-bellows” assembly. A push button shaped like a thumbtack is soldered to the top of the bellows, whose bottom then fastens and seals mechanically to the handpiece body. This creates a total hermetic seal for the switches.

The push button has an actuator pin on its underside, not unlike the shaft of a thumbtack. The surgeon’s pressure on the button compresses the bellows like a spring, engaging and closing the electrical spring contacts inside the handpiece body. When the surgeon eases up, the bellows recovers, breaking the circuit.

The push button is a one-piece stainless-steel screw-machined part; the bellows is electrodeposited nickel. The entire push button assembly measures only 0.200 in. high by 0.312 in. diam. Bellows walls measure just 0.0005 in. thick.

The walls didn’t start out that thin, though. When surgeons tried the first redesigned prototype, they found the new switches a little too stiff, or hard to depress. So Servometer slenderized the bellows walls by 0.0002 in. to pare the spring rate and improve the touch.

“That’s one design advantage of electrodeposited bellows,” says Paul Hazlitt, Servometer’s director of engineering, who partnered in the redesign. “Convolutions can be much finer and walls much thinner than in press-formed bellows. We can fine-tune the touch, and still provide an absolute dynamic hermetic seal. Electrodeposited bellows can be made as conformable as a Slinky toy.”

For antiseptic and corrosion-resistance reasons, the entire bellows-actuator assembly is gold plated. Servometer provided the complete plated bellows-and-push button assembly.

Copyright ©2004 Medical Product Manufacturing News

Three Brands Can Be Accessed via One Web Site

Originally Published MPMN January 2005 NEWS

E-News

Three Brands Can Be Accessed via One Web Site

Analee Zelaya

www.okinternational.com

OK International (Menlo Park, CA) has launched a redesigned Web site that integrates products and technical information from its brands: Techcon Systems, Impell, and Metcal. Users are linked to each brand’s individual Web site, which will soon be available in the local language of the company’s various locations. Furthermore, product and process information also can be accessed through the main Web site’s applications, industry segments, and product search capabilities. “As our customers and distributors continue to face time and cost pressures, we want to do everything possible to make their jobs easier, and that includes taking advantage of on-line information systems,” says Sherilyn Hill, marketing communications manager at OK International.

The Web sites of Techcon Systems (www.techconsystems.com) and Impell (www.impel.com) feature easy navigation and new aesthetics with an easy-to-view format. The applications area of the Techcon Systems Web site provides a comprehensive service that may save time and money for those seeking options for fluid dispensing. Users can select their application by industry sector and instantly find the most suitable Techcon products for their task, as well as links to detailed technical specifications of these products. Additionally, if a specific application is not listed, users may complete a short on-line form and receive technical assistance. An e-mail confirms receipt of enquiry, then a company representative telephones to discuss the enquiry.

Impel’s Web site has information on the benefits to employees and employers of using professional-grade air-purification and fume-filtration systems. Both benchtop and in-line systems are offered in the product line.

Metcal, which can be accessed directly at www.metcal.com, provides products, services, and solutions that enhance the productivity of electronics manufacturing. For instance, Metcal’s ergonomic hand pieces reduce fatigue, while its simple controls can minimize errors.

Copyright ©2005 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN January 2005 NEWS

E-News

My Favorite Bookmarks

Lynne Todd, Technology and Operations Manager
Invibio

Lynne Todd

MatWeb (www.matweb.com) includes a searchable database of material data sheets, including property information on thermoplastic and thermoset polymers such as ABS, nylon, polycarbonate, polyester, polyethylene, and polypropylene; metals, including aluminum, cobalt, copper, lead, magnesium, nickel, steel, superalloys, titanium, and zinc alloys; ceramics; and semiconductors, fibers, and other engineering materials.

Yet2.com (www.yet2.com) is a virtual technology marketplace aimed at bringing together those looking to access, sell, license, or jointly develop innovative technology and intellectual property. The site also offers services for optimizing the value of intellectual property and closing capability gaps.

DaVinci-Online (www.davinci-online.com) is a technology transfer and innovation management site that enables independent inventors, companies, and R&D institutions to promote and commercialize their intellectual property, such as inventions, technologies, patents, brands, trademarks, and digital content.

FirstTuesday (www.firsttuesday.com) is a forum that links leading players in the technology sector. This is a resource for everyone from entrepreneurs and managers of new ventures to venture capitalists and investors, service providers, and corporate “intrapreneurs” or technology managers.

esp@cenet (www.espacenet.com) is a free information service from the European Patent Organisation. Site visitors can search 45 million patent documents or use the forum to exchange views with other users. Alternatively, there are links for learning more about European intellectual property networks and databases, plus IP training and events.

TheFreeDictionary (www.thefreedictionary.com) is a comprehensive reference resource. The site includes English, science, medical, legal, and computer dictionaries. A thesaurus, encyclopedia, literature reference library, and search engine are also
featured.

Invibio (Greenville, SC; www. invibio.com) provides biomaterial solutions to the medical device market and is the worldwide manufacturer and distributor of both PEEK-Optima and PEEK-Classix polymers, suitable for medical devices and pharmaceutical applications. Invibio's PEEK-based polymers are produced at its headquarters and manufacturing facility in the United Kingdom. Invibio Ltd. is a wholly owned subsidiary of Victrex plc.

Corinne Litchfield

Copyright ©2005 Medical Product Manufacturing News

In Brief

Originally Published MPMN January 2005

INDUSTRY NEWS

In Brief

Banner Engineering’s (Minneapolis; www.bannerengineering.com) PresencePlus P4 vision sensor was selected as a finalist for the 2004 Product Design and Development Engineering Awards… B. Braun OEM/Industrial, B. Braun Medical Inc. (Bethlehem, PA; www.bbraunusa.com) has entered into an agreement with Adventist Health System, a hospital and home-health-care facility, for its line of infusion products… Phoenix X-ray Systems + Services Inc. (St. Petersburg, FL; www.phoenix-xray.com) has completed the movement of its U.S. headquarters from Camarillo, CA to St. Petersburg… Adhesives Research (Glen Rock, PA; www.adhesives research.com) celebrated the fifth anniversary of its European headquarters… Future Health Corp. (Timonium, MD; www.futurehealth.net) has relocated to a 473,000-sq ft, two-story facility in Hunt Valley, MD.

Copyright ©2005 Medical Product Manufacturing News

Replacement Biopsy Channel Patent Filed

Originally Published MPMN January 2005

Industry News

Replacement Biopsy Channel Patent Filed

Susan Wallace

A replacement biopsy channel is made of two kinds of PTFE.

International Polymer Engineering (Tempe, AZ; www.ipeweb.com) has filed for a second patent describing a replacement biopsy channel for the repair and OEM endoscope manufacturing industry.
The inner layer of the channel is made of solid PFTE. Its inherent lubricity allows instruments to pass freely with minimal drag.

The outer layer is porous PTFE with a spiral wound support incorporated into the structure for radial support of the inner layer. This layer acts like a spring wrap and provides kink and compression resistance.

Both layers of materials have a long history of use in medical products and have a Class VI implant rating. The company has also designed and developed suction channels and light-guide covers for OEMs.

Copyright ©2005 Medical Product Manufacturing News

Coinjection Blow Molding Systems Introduced for Medical Applications

Originally Published MPMN January 2005

Injection blow molding machines from Uniloy Milacron integrate coinjection systems from Kortec for the production of medical containers with barrier properties.

Although it is one of the leading suppliers of turnkey coinjection systems in the world, Kortec Inc. (Ispwich, MA; www.kortec.com) has not been on the med-tech industry's radar. Until now. The firm recently teamed with Uniloy Milacron (Manchester, MI; www.milacron.com) to develop coinjection blow molding systems specifically for healthcare applications. The first UMIB 85.S machine was recently sold to a medical device OEM.

The project had its genesis in a "what-if" question posed by a customer.

Kortec is well regarded for its three-layer preform technology that combines PET with barrier materials. The multilayer construction offers clarity and strength while maximizing a product's shelf life. Intrigued by the possibilities, a medical device manufacturer wondered if the technology could lend itself to smaller cavity molds and to the use of resins other than PET. "That was not possible with the existing commercially available equipment," says Douglas Svik, new applications manager at Uniloy Milacron. "So Kortec turned to us to supply injection molding capability for their coinjection technology."

Kortec's coinjection system is integrated into Uniloy Milacron's injection blow molding machines. The true reciprocating-screw injection unit and closed-loop control of independent fill and recovery pressures meshed well with Kortec's technology, according to Kortec vice president of marketing and sales John Kermet.

Kortec typically partners with clients to provide turnkey application-specific systems. After consultation with customers, the units are designed and built at the Kortec plant, where the cell is "proved out" before being disassembled and shipped to the client. There it is reassembled and put into production. Kortec manages the entire project and provides customer training and technical support.

The initial medical application involves molding a multilayer container that sandwiches polyamide between two layers of polycarbonate. The product is transparent and virtually unbreakable. In the past, "much of the industry has extrusion blow molded these types of containers," says Svik. "But you can't get the precise tight-tolerance finish that you can with injection molding. This development by Kortec has taken what was achievable only by means of a highly proprietary process and made it a commercially available technology," Svik adds.

The systems are suited for molding an array of bottles, vials, and single-use products. "Any number of medical products that require the use of a barrier material are potential applications," notes Svik. The first unit produced for a medical device company has four cavities, but higher cavitation units are being readied.

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