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Articles from 2005 In April


Injecting Progress into Molding

Originally Published MPMN April 2005

PRODUCT UPDATE

Injecting Progress into Molding

New technologies and business practices generate savings

Analee Zelaya

Demag Plastics Group introduces the IntElect series with direct-drive technology. Already proven in Europe, the all-electric IM machine features NC-4 control.
Cost-effectiveness seems to be on the minds of suppliers of molding services and equipment. Whether it be where the devices are manufactured or how efficiently, molders are offering ways to save money. Saving time is also a goal for molders. While some are reducing setup and lead times, others are using innovative materials or introducing new technologies to make products more readily available.

Chinese Molder May Save OEMs Time and Money While Maintaining Standards

Quality Biomedical Manufacturing Ltd.
(QMB; Fotan, Hong Kong) provides molding for North American and European medical device manufacturers. Using CGMPs in Chinese factories, QBM can mold high-performance resins on 28- to 500-tn injection molding machines. The company has also produced millions of parts using other materials such as rigid and flexible PVC, polycarbonate, ABS, polypropylene, and Kraton thermoplastic rubber. Labeling of components using engraving, hot stamping, and pad printing is also offered, along with insert molds that use metals and plastics.

QBM is currently installing a new 1500-sq-ft Class 10,000 cleanroom in its Lung Wah, Hong Kong factory, which was scheduled to be completed and certified in the first quarter of 2005. This facility will be used exclusively for medical device assembly. The firm is also considering a joint venture for molding silicone medical devices in a separate Class 100,000 cleanroom on the same floor.

According to company president Sean Lundy, potential customers who question the ability of China-based subcontractors to meet the standards of medical device OEMs should rest at ease. He points out that factories in China have a long history of ISO and GMP compliance. “I have found that it is not usually the standards of the Chinese factories that are lacking, but the knowledge of such compliance amongst Western medical device manufacturers,” he says. “It is rare that prospective customers have any quality concerns after they visit our factories for a quality audit. However, in such an instance, I might suggest that they first try out QBM with a project where quality issues are minimized, but where the economic value of China outsourcing can be maximized.” Lundy maintains that an export-tooling project might be the right fit in this case. He adds that an equivalent injection molding tool in the United States might be three to eight times more costly than QBM’s, and that his company can often deliver its products in half the time of a U.S. vendor.

Unlimited turns are possible with the CNC servomotor-controlled core from B A Die Mold.

QBM offers 300% inspection, meaning that every molded part is inspected by three people, to ensure quality. The company has no minimum run-size requirements.

Small, Quiet Machine Makes Noise in Injection Molding

A direct-drive molding technology is available in 55- to 165-tn all-electric injection molding machines. According to Demag Plastics Group (Strongville, OH), these units are quicker, cleaner, and more precise than its 220- to 385-tn versions that feature the traditional belt-drive molding technology. The company gives molders in the medical industry both options through its IntElect series of injection molding machines. They are often used in liquid silicone molding because of their high degree of accuracy in controlling the position of the screw.

“While [it is] new to North America, our European operations have been building and selling IntElects with direct-drive technology since [early in 2004],” says Tim Glassburn, IntElect series product manager. “The direct-drive technology has already proven itself in real-world applications and in tests since we first exhibited it as a prototype in 2003.”

The all-electric belt-drive technology is most commonly used today. It offers maintenance and productivity benefits compared with its hydraulic counterparts in certain applications. However, it requires gear trains for rotary and translatory movements of the machines. While quieter, cleaner, and more efficient and precise, the equipment tends to be more costly than hydraulic systems because of its high-speed, low-torque motors combined with reduction gearing.

Incorporating synchronous, high-torque, water-cooled direct drives, Demag’s smaller-tonnage IntElect models do not rely on reduction gears and mechanical transmission components. Instead, direct-drive technology calls for only a few parts, resulting in reduced maintenance time and costs.

The IntElect series uses NC-4 control, the firm’s global machine control system. A high-torque motor on the end plate powers the opening and closing movements of the direct-drive IntElect mold. The motor transmits rotation using a ball screw to the toggle system, which induces the axial movement of the moving platen. Rapid response and precise mold movement, resulting from the accuracy and short reaction time of the motor, are the advantages of the toggle clamp.

Useful Prototype Accelerates Transition to Production

Stockwell Rubber Co. fabricates and molds silicone rubber components.

A company, specializing in injection molding has automated and standardized its entire injection molding process. Prototype Plus, a rapid tooling system from J&L Plastic Molding (Wallingford, CT), offers design engineers or product developers a way to test new injection-molded parts, and then transition into production.

“Customers can get their parts with any grade of material, and run production off those tools as well,” says Marty Kellaher, the company’s vice president of marketing. “They don’t need a prototype, then a secondary tool.”

Kellaher explains that some companies use aluminum or cast molds, the output of which cannot satisfy production needs. However, J&L machines everything soft in S-7 steel. Then, once the part is approved, the steel is hardened. Production-type numbers are then possible.

The system accelerates time to market, because it combines CAD/CAM, automation, and craftsmanship. Once the customer gives J&L a CAD file, the firm can be cutting steel within hours, since it fabricates and maintains all the mold components it needs. J&L has also created a whole framing system. This saves money for customers by eliminating the need to buy a frame or do lead work.

Typical lead time is 3 weeks or less when parts require high-speed CNC machining. Electrical-discharge machining (EDM) technology may be employed to achieve desired finishes and intricate shapes. Up-and-down part to 90° side-action designs are accommodated.

Additionally, customers end up owning their mold components. As a result, if at any time they want to transition to traditional framing, they can do so.

Company Strives for Core Positioning

A patent is pending on a CNC servomotor-controlled core that offers accurate, fast, and efficient core positioning with unlimited turns and programmable speed profiles. Ideal for electric molding machines, the PERC System is offered by B A Die Mold (Aurora, IL). The firm designs and builds molds for clear and optical parts, as well as close-tolerance internal and external threaded applications.

Molding Performed On-Site

ISO 9001:2000–certified Stockwell Rubber Co. (Philadelphia) offers in-house compression, injection, and custom molding. The company’s main focus is providing die-cut, fabricated, and custom-molded components in silicone rubber and similar high-performance elastomers. These components are most often specified to meet requirements such as special ESD and EMI shielding in high-technology OEM equipment designs.

The firm employs lean business practices to reduce setup costs. This provides unit cost reductions in curtailed production runs and shortens lead time.

Copyright ©2005 Medical Product Manufacturing News

OutsourcingOutlook

Originally Published MPMN April 2005

Outsourcing Outlook

Extrusion


Various Tubing Types Provided by Precision Extruder

Precisely extruded thermoplastic tubing is available in quantities from prototype through production. The company manufactures single- and multilumen tubing in sizes up to 0.400 in. and to customer specifications. Bump, coextruded, and overextruded tubing are offered in both single- and multilumen varieties. Materials include thermoplastics, polyurethane, nylon, polypropylene, low-density polyethylene, and natural or filled polyesters. Real-time statistical process control is offered as well. The manufacturing facility is ISO 9001:2001 compliant. Dunn Industries Inc., Manchester, NH www.dunnindustries.com


Medical Extrusions Produced in a Pyrogen-Controlled Cleanroom

An extruder of thermoplastic materials operates in a Class 100,000 cleanroom and is ISO 9001:2000 and ISO 14001 certified. Capabilities include statistical process control documentation, on-line measurement controls, in-house wire EDM CAD/CAM systems, printing, bar coding, subassembly, and packaging. Single- and multilumen tubing, reinforced high-pressure tubing, coextrusions, and triextrusions are among the products offered. The company specializes in medical-grade flexible tubing, rigid tubing, and custom profiles. Class VI materials include PVC, polyethylene, polypropylene, polyurethane, polycarbonate, nylon, thermoplastic elastomers, and polyvinyl chloride alternatives. Just-in-time inventory and shipping programs are available. Two manufacturing facilities--one in Northborough and one in Athol, MA, total more than 140,000 sq ft. Bunzl Extrusion Massachusetts Inc., Athol, MA www.bunzl.com


Extruder Offers Single and Multilumen Thermoplastic Tubing

A custom extruder of small-diameter, tight-tolerance thermoplastic tubing offers design assistance as well. Products can be extruded as single- or multilumen, or coextruded using a variety of thermoplastic materials. Working closely with its customers, the company's experienced staff can provide solutions to design questions during the critical early stages of new product development. An in-house tool design and manufacturing department lends itself to rapid turnaround of product prototypes, according to the company. Precision Extrusion, Glen Falls, NY www.precisionextrusion.com

Copyright ©2005 Medical Product Manufacturing News

Filters

Originally Published MPMN April 2005

SPOTLIGHT

Filters

In-line filter

An all-PTFE filter provides a highly inert flow path that protects laboratory equipment by trapping particulate matter. The filter comes with a replaceable element designed to remove particulates from fluids that could otherwise cause damage to laboratory pumps, valves, and other mechanical liquid-handling devices. A filter housing imprinted with a spoke-style distribution pattern distributes the fluid over the entire filter surface area to ensure maximum filtration. Connection options include male/female 1¼4 to 28 and female/female 1¼4 to 28 threaded options, plus a barbed version for 1¼16 in. inner diameter softwall tubing. Bio-Chem Valve Inc., Boonton, NJ www.bio-chemvalve.com


Transfer and filter devices

A complete line of transfer and filter devices are offered for a variety of fluid-transfer applications. The DP1000 dispensing pin features a bacteria-retentive air-venting filter that simplifies aspiration and injection and minimizes the chance of contamination. The fluid channel design allows for complete withdrawal of medication. The CDP-2000 chemo-dispensing pin captures airborne agents that can be released during the drug-preparation process and provides protection from aerosolization hazards. The Filter Straw particulate matter filter removes glass particles that result when ampules are opened. The product features a 5-µm filter, and is available in lengths of 4 in. and 1.75 in. B. Braun Medical Inc. OEM Industrial Div., Bethlehem, PA www.bbraun.com


Luer filters

A line of female luers can be used in pneumatic and fluidic applications. The filters are mounted in nylon, polypropylene, or Kynar luers to work with a range of customer needs. The units can be used to protect valves, miniature pumps, and analysis equipment. Female luers are offered with male luers, male luer locks, bulkhead hose barbs, and hose barbs from 1¼16 to 5¼32 and 10-32 to 1¼4-28 UNF threads. Types of filter media available are nylon, polypropylene, and fluorocarbon in various sizes from 10 to 200 µm. Pneuline Supply Inc., Greeley, CO www.pneulinesupply.com


Self-priming IV filters

Adult IV filters have acrylic housing with hydrophilic PES filters and hydrophobic PTFE vents. Part #28220 has a 0.2µm membrane with clear housing. Part #28221 has a 1.2µm membrane with transparent blue housing. The filters measure approximately 3 ¥ 1¼4 ¥ 1 1¼3 in. and contain two ports to fit 0.120 to 0.125 in. tubing. The rectangular filters are molded with an arrow on one side to indicate direction of flow and are self-priming to vent air in the line. Qosina, Edgewood, NY www.qosina.com


Filter fabrics

Fabrics act as security filters and as wicking and spreading media. Examples include infusion sets and transfusion sets, arterial and cardiotomy blood filters, blood bags, dialysis sets, and diagnostic test strips. Medifab fabrics are routinely tested for endotoxins and hemolytic substances. USP Class VI, ISO 10993, and cytotoxicity tests are performed regularly. Surface treatments including hydrophilic and hydrophobic coatings and plasma are available to enhance priming, wetting, and wicking properties. Sefar, Depew, NY www.sefar.us

Copyright ©2005 Medical Product Manufacturing News

Machining

Originally Published MPMN April 2005

SPOTLIGHT

Machining

Machining center

A machining center is suitable for the tool and die and medical device markets. The Model 2626XP is a five-axis programmable abrasive water-jet machining system that produces complex parts out of most materials. It offers positioning accuracy with ±0.001 in. directly from a CAD drawing or .DXF file. The unit comes standard with the company’s technology suite software, a stainless-steel tank and slats, a cutting head that automatically eliminates taper, and a cutting nozzle that offers minimal a kerf of 0.022 in. and an inside radius of 0.011 in. for fine detail work. Omax Corp., Kent WA www.omax.com



Positioning system

A computer-controlled, software-driven 3-D positioning system is suitable for machining 3-D surfaces or presenting any facet of a 3-D object to process tooling. The Cybaman Replicator combines optical digitization and robotic manipulation in one machine. The unit is designed for high-speed machining of plastics, wood, aluminum, and steel. It can be customized for specific applications. Alternative tooling options include machining, grinding, welding, optical inspection, and laser cladding, coating, or drilling to be carried out on any 3-D surface feature. Erothitan Titanium Implants SA, Suhl, Germany www.erothitan.com


Digital converting

Digital converting is available as an enabling technology for the pattern converting of intricate components and multilayer laminates to be used in microfluidic and IVD devices. Using LaserSharp, medical device manufacturers can produce components that cannot be made using conventional methods because of feature sizes, feature locations, or tolerances. General feature sizes can be processed to 100 µm, with tolerances of ±50 µm. The high-speed converting method can process roll or sheet-fed materials in a continuous or intermittent format. LasX Industries Inc., White Bear Lake, MN www.lasxindustries.com


Metal and plastic machining

A company has expertise in both metal and plastic machining. Services include prototype, short-run, and production quantities. Design assistance is also available, as well as rapid prototyping, thermoform packaging, fabrication, and injection molding. Plastic & Metal Center, Laguna Hills, CA www.plastic-metal.com


UV laser micromachining

A company offers precision UV laser micromachining services with micron-scale features and submicron tolerances. Typical applications include microfluidics; sensors; nozzles; microscreens; particle traps; MEMS; MOEMS; microdicing; biosensors; microvias; photo-ablation; photomachining; micromachining of plastics, ceramics, hard dielectrics, glass, and metals; nondestructive high-resolution marking; microlithography to 1 µm resolution; high-speed drilling; and selective material ablation. Examples of materials processed are polymers and plastics, ceramics, glass, metals, semiconductor materials, and diamond and precious metals. JPSA Laser, Hollis, NH www.jpsalaser.com


Vertical machining

A vertical machining center reduces residual vibration and gives users the ability to contour more accurately and accelerate among positions 54% faster than with previous versions. The NV4000 DCG contains five ball screws—two on the y-axis, two on the z-axis, and one on the x-axis—that enable a reduction in vibration without sacrificing speed for accuracy. The unit’s design allows machining forces to traverse across the arch-shaped column and through the bed, thereby forming a closed loop. Tool-changing time is 2.8 seconds chip-to-chip and1.0 seconds tool-to-tool. Mori Seiki, Irving, TX www.moriseiki.com


Swivel head

A vertical machining center incorporates a swivel head spindle for single setup machining of complex parts. The FZ08KS tilt machine has a swiveling range of –20° to 115°, and it takes 0.5 seconds to swivel from 0° to 90°. Applications include orthopedic devices and surgical instruments made of special plastics, titanium, and steel. With the swivel head, users can produce milled surfaces and holes at every angular position, including outer and inner contours, and tapping. The machine features a tool changer that takes 0.8 sec from tool to tool, a chip-to-chip time of 1.9 seconds, rapid feed up to 3000 in./min, acceleration rates up to 2 g, and spindle speeds up to 40,000 rpm. Chriron America, Charlotte, NC www.chironamerica.com

Copyright ©2005 Medical Product Manufacturing News

Integrating Automatic Leak Testing with Assembly Cuts Costs

Originally Published MPMN April 2005

PROFILE

Integrating Automatic Leak Testing with Assembly Cuts Costs

Molecular diagnostics firm boosts output for lab testing

Open-ended cap blanks enter the assembly and test machine from a centrifugal bowl feeder.

When the very reason a product becomes successful starts threatening its continued success, something has to change. For Gen-Probe Inc. (San Diego, www.gen-probe.com), a developer of genetic diagnostics for disease testing, that happened when its newest test for sexually transmitted diseases proved so sensitive that it could respond to specimens opened for similar test processing elsewhere in the lab. Solving that problem by inventing a new type of penetrable sealed cap for specimen tubes promptly led to another problem. The cap worked so well that rising customer demand for its use in other Gen-Probe assay kits promised to exceed the company’s ability to produce and test them. An advanced system integrating automated assembly and testing became an urgent priority, not only for increasing volume, but also for cutting costs.

The company’s Aptima Combo2 assay is believed to be the first to provide simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections using urine or ocular fluid samples. Its performance is equivalent to first-generation tests that required intrusive and sometimes painful swab samples.

Detecting both diseases from one sample also serves the user laboratories’ pressing need to improve their productivity. The assay portion of the test procedure, in which the patient sample is processed for diagnostic conclusion, typically involves a 5-hour sequence of heating, mixing, separating, applying reagents, and reading results with special instruments.

The assay uses the company’s patented technology for nucleic acid amplification, called transcription-mediated amplification (TMA). This greatly enhances sensitivity over previous versions of the test. Along with this improvement came a big problem, recalls director of OTS manufacturing engineering Dale Camper, “With our [previous] system, physicians would place swab specimens into capped tubes that were supplied preloaded with fluid-transport media,” he says. “Handling naturally caused swab and fluid to slosh around inside the tube, often forming bubbles beneath the cap. When the cap was removed in the lab, the bubbles would pop and release tiny droplets into the air. These aerosols were far too small to register on nearby assays, much less have any effect on lab personnel. However, Aptima with TMA could pick up these tiny aerosol traces and signal a false rRNA detection.”

Two IDC M-1045 vacuum-rise leak detectors (above) simultaneously test two caps on pallets passing below.

Rather than compromise the assay’s sensitivity, the company’s scientists focused on eliminating the need to uncap the tube. Taking that approach led to a new penetrable cap design comprising a hollow cylinder with a membrane seal across its midplane, another seal across its outer end, and a filter pile packed in between. The cap remains on the tube but allows assay samples to be drawn by inserting a pipette through the seals and filter. The snug fit between seals, filter, and pipette prevent any aerosol emission, and the resilience of the filter pile automatically recloses the hole left after the pipette is withdrawn. These features also isolate the specimen in the tube from any airborne contaminants in the area.

The redesigned cap became part of a broader concept called direct tube sampling (DTS). “Then came another problem,” Camper says. “Early users of Aptima immediately began urging us to use the same type of specimen tube and cap for other assay kits. Projections for that suggest we’ll be making 50% more of these within a year, and probably averaging year-over-year gains of at least 20% for a while after that. So now we needed a way to produce the caps in much higher volume yet test each one for seal integrity.”

The Aptima cap starts out as an open-ended cylinder molded of white polypropylene, approximately 16 mm in diameter and 17 mm long, with a 1.6-mm-wide flange around the inside circumference at mid-length. This internal flange provides the seat for the internal membrane seal, which is a disk made of aluminum foil laminated onto a polyester-polyethylene film. The film reinforces the foil’s vapor barrier while providing a surface that will heat-bond to the cap’s flange by induction welding under pressure. During cap assembly, the inner seal is mounted first, then a strip of filter pile material is coiled and inserted above that seal, and a second foil-disk seal is applied across the cap’s upper end to lock the filter in place. The cap’s lower end below the welded seal is molded with female threads that screw onto the sample tube.

In the initial production of Aptima kit components, all caps were made essentially by hand. After the inner seal disk was peeled off a Mylar backing and welded in, each cap was leak tested to verify the sealing integrity of both the foil disk and its perimeter weld. For that, the caps were taken off-line manually and loaded into a ten-up fixture, which applied 10-psi air pressure against the underside of the middle seal. Pressurizing and stabilizing took 2.5 seconds, then the test measurements took another 2 seconds. Acceptance was limited to batches that allowed a pressure loss no greater than 0.007 psig. Accepted caps were carried back to the assembly line for manual addition of their filter pile and upper seal.

Caps seated on in-line pallets departing the first seal insertion stations (left) immediately pass through leak testing (right); rejected caps are denied further assembly, saving additional materials.

“As soon as we realized the increasing volume potential,” Camper says, “we knew we were in trouble. Our four manual assembly stations, rotating five people, could produce no more than 15,000 caps per week. The 4.5-second leak test, which lost additional time in the manual transfer from and back to the assembly line, was far too slow, yielding about 20 caps per minute at best.”

Returning to the local systems integrator that built the Aptima assembly equipment, PhedCorp (Anaheim, CA; www.phedcorp.com), Camper sought a fully automated alternative that would combine assembly and testing into a faster process that eliminates the need for in-process manual handling.

“At first, we simply envisioned an automatic version of the manual pressure test that we had been using,” he recalls, “but the vendor that supplied that tester to PhedCorp couldn’t seem to come up with faster speeds.”

Gen-Probe evaluated several alternative vendors and selected InterTech Development Co. (IDC; Skokie, IL; www.intertechdevelopment.com) to provide the leak testing system. By that time, PhedCorp was well along in establishing the new assembly-test machine as an in-line system that would receive cap blanks from a centrifugal bowl feeder; load them into conveyor pallets in pairs, threaded end down; then advance the pallets through a sequence of stations including a leak testing station positioned immediately after induction welding. To keep machine design as simple as possible, all assembling and test functions would be performed from above the pallets.

“One of IDC’s first contributions was the observation that the caps would be arriving upside down for the kind of pressure test we envisioned,” Camper notes, explaining why. “Although Aptima sample tubes are not inherently pressurized, we knew they often would be shipped by air. It made sense that our cap seal tests should be pressurized from the open end to simulate the pressure differential likely to build up inside the sealed tubes due to lower ambient pressures during flight. But in our machine, the open end faced the wrong way.”

“Air shipment considerations also shaped our 10-psi test pressure,” he adds. “We researched Federal Express temperature and pressure standards for cargo holds in various types of aircraft flying at different altitudes, calculated the highest probable differential, and added a conservative margin of safety to arrive at our spec.”

To avoid adding complexity to the machine PhedCorp was developing, IDC proposed replacing the pressure test, which would have to be performed from below, with a –10-psig vacuum test performed from above. In addition, switching to vacuum technology would make it easier to meet Gen-Probe’s 1.5-second test cycle time requirement, in part because a vacuum inherently requires less stabilizing than pressurization does. Also helping to cut stabilization time, the vacuum environment prompts quicker fixture-to-part sealing.

Further promoting faster cycle time, IDC customized its M-1045 leak detector, a computerized pressure-decay instrument, to measure low-level vacuum rise in low-volume test parts, and provided guidance for PhedCorp’s design of the new machine’s leak testing fixtures for best possible coordination among instrument, fixtures, and test circuit. When the fixture descends and seals against the top of the cap, it encloses a test cavity slightly less than 0.5 cm3 from which the M-1045 draws its vacuum. Leakage would reveal itself by a rise of the vacuum. In order to provide a volumetric leak-rate measurement traceable to an industry standard that accounts for test-part volume, the M-1045 converts its vacuum-rise measurement into standard cubic centimeters per minute and reports that value numerically on its front-panel display. Gen-Probe’s previous acceptance limit of 0.007 psig, programmed into the M-1075 via a front- panel keypad, converts to 0.343 sccm.

Completed caps, designed to keep specimen tubes closed, feature a midplane seal (right) and a top seal (left), with a special filter between the seals.

Although the instrument continuously displays real-time test vacuum and leak-rate values, front-panel lighted indicators also show amber for test in progress, green for accept, and red for reject, providing an immediate visual alert requiring no operator judgment. More important for integrated assembly/test systems, the instrument responds to and shares its information with the assembly machines’ PLC through its bidirectional RS-232C interface.

Two M-1045 instruments mounted side-by-side within the PhedCorp machine test two caps simultaneously, letting accepted caps proceed to completion. Whenever a cap fails its leak test, the M-1045 tags it electronically to inhibit further assembly, avoiding waste of the filter and second seal that otherwise would be added downstream.

Filter pile and top seal are inspected by machine vision for proper placement, and likewise tagged to guide further machine activity. At the end of the line, separate accept and reject chutes arc down over the passing pallets, and based on electronic tagging from the leak tester and machine vision system, puffs of air from below blow each cap into the appropriate chute for collection in separate bins.

“So far, we’ve not calculated the material cost savings from inhibiting the completion of caps rejected in the leak tests,” Camper notes, “but we know some savings exist because production records maintained in the system indicate a reject rate of between three and five percent, with one-third to one-half of them recorded at the leak testing stations. Among the leak rejects, we’ve had instances where the reject was attributable to wear on the fixture seal rather than a leaking cap, and we were able to catch it very early due to the IDC instrument’s seal-check feature, which detects the slightest change in seal integrity.”

PhedCorp’s president Bassam Poullath says, “The other vendors we looked at were more price-attractive, but IDC offered a true turnkey test station that we could simply drop into our machine, very user-friendly with very good documentation. The others left a lot for us to add or figure out before we could put the tester into place. IDC also helped us with designing the method of sealing our test fixture to the test part. . . they shared their concepts, provided photos and drawings of other fixtures they designed for similar applications, and basically showed us what we needed to do. That made it easy to achieve a seamless integration.”

Copyright ©2005 Medical Product Manufacturing News

Plastics Are Clearly Safe, Tough, and Chemically Resistant

Originally Published MPMN April 2005

E-News

Plastics Are Clearly Safe, Tough, and Chemically Resistant

Analee Zelaya

www.clearlymedical.com

Eastman Chemical Co. (Kingsport, TN) has launched a Web site that is dedicated to plastics solutions for the medical device industry. It features case studies to demonstrate the clarity, toughness, chemical resistance, and safety of the company’s specialty plastics when used in medical devices such as syringes and blood recovery systems.

The site demonstrates the versatility that the firm’s plastics bring to project engineers, whether it is in molding complex shapes or retaining clarity after sterilization, notes Thijs Jaarsma, Eastman’s global market development manager. Eastman also manufactures chemicals and fibers worldwide.

Copyright ©2005 Medical Product Manufacturing News

Contract Manufacturer Establishes Web Site

Originally Published MPMN April 2005

E-News

Contract Manufacturer Establishes Web Site

Caitlin Cook

www.atekmedical.com

A recently launched Web site details a company’s contract manufacturing capabilities. A two-year period of significant growth for the company, including the acquisition of additional land and buildings, provided the stimulus for the new site. ATEK Medical Manufacturing (Minneapolis) provides manufacturing, supply chain, and new product support services for subassemblies and finished products. CEO Christy Bieber Orris comments, “While the Web site can’t replace meeting our team on a face-to-face visit, this site will allow visitors to see what ATEK is all about.”

Copyright ©2005 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN April 2005

E-News

My Favorite Bookmarks

Mike Marhoefer, Manager of Electronics and Brushless Motor Technologies
Bodine Electric Co.

Mike Marhoefer

eFunda (www.efunda.com), short for engineering fundamentals, is a reference guide for technical information, conversion calculators, formulas, and handheld computer downloads. Engineers can quickly find concise and reliable information to meet the majority of their daily reference needs. eFunda is a reminder source for various formulas, and tells you exactly under what conditions those formulas apply.

Pdf995 (www.pdf995.com) contains low-cost PDF conversion and editing tools. The site makes it easy and affordable to create professional-quality documents in pdf file format. Pdf995 supports network file saving, fast user switching on XP, Citrix/Terminal Server, custom page sizes, and large-format printing.

The Underwriters Laboratories (UL) Web site (www.ul.com) allows me to look up products and companies with approvals, find approved insulation systems available for use, and locate standards for products. UL is the trusted source across the globe for product compliance. It has a unique mix of local expertise in global markets and deep industry knowledge that helps bring safe products to market faster.

ZDNet (www.zdnet.com) provides a variety of forums from information on virus attacks to software downloads to ratings of computer and consumer hardware and software products. ZDNet operates a worldwide network of Web sites that offer content, services, and commerce opportunities that enable IT professionals and business influencers to gain an edge in business. The site provides an invaluable perspective and resources so that users can get the most out of their investments in technology, with sections covering product news, technical information, blogs, white papers, downloads, reviews, and prices.

Bodine Electric Co. (Chicago, www.Bodine-Electric.com) offers a range of more than 850 stock motors and gearmotors worldwide, including ac, dc, and brushless dc. Each motor is complemented by system-matched Bodine motion controls. The company also offers custom motors with engineering support for concurrent product development.

Corinne Litchfield

Copyright ©2005 Medical Product Manufacturing News

IN BRIEF

Originally Published MPMN April 2005

INDUSTRY NEWS

IN BRIEF

West Pharmaceutical Services Inc. (Lionville, PA; www.westpharma.com) has acquired Monarch Analytical Laboratories Inc. (Maumee, OH), which provides a variety of testing services, and will operate under the name West Monarch Analytical Laboratories.

Ampac Packaging LLC (Cincinnati; www.ampaconline.com) has acquired Flexicon Inc. (Cary, IL; www.flexiconinc.net), a manufacturer of high-performance, flexible packaging materials.

ISO 9001:2000–certified Prent Corp. (Janesville, WI; www.prent.com), a global manufacturer of custom plastic thermoformed packaging, has announced that it has received seven industry awards, including four AmeriStar and two WorldStar Awards. The company will begin production in Puerto Rico in July.

Creganna Medical Devices (Galway, Ireland; www.creganna.com) which specializes in minimally invasive devices, has formed a partnership with TDC Medical (Westbrough, MA; www.tdcmedical), which will offer regulatory assistance for FDA submissions. The firms will provide design and development services to the medical device industry from a Boston facility.

Spirol Industries Ltd. (Danielson, CT; www.spirol.com), a subsidiary of Spirol International Corp., has added to its line of engineered fasteners by acquiring assets and the ongoing business of GE Bissell Ltd. (West Midlands, UK; www.bissell.co.uk).

Micro Stamping Corp. (Somerset, NJ; www.microstamping.com) has opened the 4000-sq ft Frank Semcer Development Center for product design and production processes.

Graco Inc. (Minneapolis; www.graco.com), a provider of fluid-handling systems and components, has purchased the stock of two North Canton, OH–based companies: Liquid Control Corp. (www.liquidcontrol.com), a designer and manufacturer of highly engineered precision resin dispensing equipment, and Profill Corp. (www.profill.com), a contract manufacturer and supplier of resin repackaging.

Hitachi Computer Products Inc., Oklahoma Manufacturing Div., (www.hitachiomd.com), an electronics contract manufacturer, has announced that its Norman, OK–based manufacturing facility has qualified for FDA registration.

Fluke Biomedical (Everett, WA; www.flukebiomedical.com), a manufacturer of biomedical test instruments, has acquired the Radiation Management Services business of Cardinal Health (Dublin, OH; www.cardinal.com), which is involved in maintaining a safe, regulatory-compliant facility in the medical imaging and therapy fields.

House of Batteries (Huntington Beach, CA; www.houseofbatteries.com), a certified woman-owned custom battery assembler and distributor, has purchased a 36,000-sq ft facility in Fountain Valley, CA that quadruples the company’s manufacturing capacity, and it also received ISO 9001:2000 certification.

InnovaQuartz Inc. (Phoenix; www.innovaquartz.com) has acquired the 3M TECS multimode optical fiber product line located in West Haven, CT. The fiber-production business will move to Phoenix.

Copyright ©2005 Medical Product Manufacturing News

Ionic Impurities in Polymers Reduced with Resin-Purification Process

Originally Published MPMN April 2005

INDUSTRY NEWS

Ionic Impurities in Polymers Reduced with Resin-Purification Process

Corinne Litchfield

A resin-purification processing service may reduce levels of ionic impurities in a range of polymers. Offered by PolyClean Technologies (Rosenberg, TX; www.polycleantech.com), the purification service provides a low-cost solution for resin suppliers.

The company reports ionic impurity reductions of up to 95%, bringing residue levels from a few hundred parts per billion down to several parts per billion. “The cleanliness and purity requirements for polymers in critical applications are becoming more demanding,” says company president Harish Sangani. “This is a challenge for resin suppliers who must find economical ways to reduce the level of residues in their virgin polymers and compounds.” Molders and manufacturers may also struggle to find suppliers with highly purified resins for low-volume applications.

By using the company’s service, resin suppliers can create high-purity grades of their standard products in order to meet their customer’s cleanliness specifications. Manufacturers can use the service to help them choose from a broader, and possibly lower cost, array of materials that meet overall performance criteria. The process can be performed on virgin pellets, accidentally contaminated materials, and regrind. Lot sizes from a few hundred pounds up to multitruckload quantities can be processed. A lab-scale system can process smaller quantities. Initial evaluation trials are offered at no charge.

Copyright ©2005 Medical Product Manufacturing News