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Articles from 2003 In November


Biomimetics—A Cure for the Incurable?

Originally Published MPMN November 2003

EDITOR'S PAGE

Biomimetics--A Cure for the Incurable?


Biomimetics. Never heard of it? You will soon. Biomimetics is the science of using microelectronics to mimic biological systems. It holds great promise for now-incurable diseases. Products based on it will one day enable implantable and portable devices that can treat such conditions as blindness, loss of neuromuscular control, paralysis, and brain injury. 
In recognition of the importance of developing this field, the National Science Foundation (NSF) has provided a grant totaling more than $34 million over two five-year terms. The grant will fund a center devoted to applying biomimetics to create medical devices. 

Medical device manufacturers will play a big part in developing these products. The Center for Biomimetic MicroElectronic Systems (BMES) will involve not only researchers, but also more than 30 medical industry partners. The center's interaction with industrial partners is expected to generate $35 million in revenue over the five-year term of the grant. Some sources say it could bring in more than $80 million in the next decade. 

The creation of BMES is important for several reasons. It will serve to advance this remarkable technology and potentially improve the quality of life of many people. Also, it "provides an educational and research environment that prepares a new generation of engineering leaders," says Dr. John Brighton, assistant director for engineering at NSF.

BMES will be located at the University of Southern California. It will operate in partnership with the California Institute of Technology and the University of California at Santa Cruz, as well as with industry partners. "One of the things we're trying to take advantage of is the very strong industry in Southern California in medical devices and diagnostics," says Gerald Loeb. A professor of biomedical engineering, Loeb is a physician who helped develop the cochlear implant. He will be the center's deputy director.

The researchers will focus on mixed-signal systems on a chip, power and data management, intelligent analog circuits, and interface technology at the nano- and microscales to integrate microelectronic systems with neurons. They will also create new materials designed to prevent rejection when implanted in the body.

A retinal prosthesis may provide artificial vision to people who have lost their sight due to diseases affecting the retina. How? By taking over the job of cells damaged by conditions such as retinitis pigmentosa. The electrodes in the array are stimulated by an incoming image. They in turn stimulate the patient's remaining retinal cells. The information travels via the optic nerve to the vision centers of the brain to create a representation of the image. Just a few electrodes are used to replace a large number of nerve fibers.

Another possible use for biomimetics that BMES will be focusing on is a cortical prosthesis. This silicon chip could be implanted into the brain to restore cognitive functions lost due to stroke or other causes. 

And finally, the center will be working on a neuromuscular prosthesis called BION. This device may be able to restore movement into a paralyzed limb. It is showing some promise. During the past three years BION has been inserted into the paralyzed muscles of 20 patients. It is meant to treat disorders ranging from stroke to arthritis. 

BMES is truly a collaborative effort and shows how industry and research can work together to create the next generation of medical devices.

Susan Wallace
, Managing Editor

Copyright ©2003 Medical Product Manufacturing News

Plastics and Elastomers

Originally Published MPMN November 2003

PRODUCT UPDATE

Plastics and Elastomers

Norbert Sparrow

Dust Removal System Gives Polymers Clean Bill of Health

Offered by Amicon Plastics, a bearing-grade PEEK material with internal lubrication
is suited for the fabrication of pump parts, shaft bushings, and other medical device components.

Dust particles that cling to plastic pellets as they are injected into molds can burn or melt into a liquid or gas. This produces foggy microbubbles or char marks on the finished part, rendering it unusable in many applications. "Flaws in medical films and related products are often caused by dust," notes Jerry Paulson, inventor of a dust removal technology and founder of Pelletron Corp., which manufactures associated equipment. The use of a dust contaminant removal system in the production process can translate into dramatic reductions in scrap and substantial cost savings, he adds. The company offers a line of equipment that is designed to make this technology accessible to small and medium-size manufacturers. This article also includes updates on recent advances in polymers with medical applications. 

Into the Flux

As plastic pellets move through a processing system, they collide with the piping and bump against each other, causing minute particles to break off. This dust reattaches itself to the pellets under the influence of a static charge and ultimately produces defects in the finished product. "Scrap rates can be huge for the manufacturer," notes Heinz Schneider, who was recently appointed president and CEO of Pelletron Corp. "One company that recently purchased our equipment was processing polycarbonate, which costs about $2.60 per pound. The firm had a parts nonacceptance rate approaching 40% before installing one of our dedusters. The return on investment was three to four weeks," says Schneider.

Pelletron's dedusting technology is built around a flux field generator, which creates a low-power electromagnetic field. This disrupts the electrostatic bond between the pellets and dust particles. The pellets and contaminants fall to the surface of the primary air wash deck, where blasts of pressurized air lift the lighter-weight contaminants above the main product stream. The pellets then pass through a venturi chamber. A stream of bypass air, whose upward velocity can be adjusted, separates the remaining dust and large stringy contaminants from the pellets. The particles are drawn by vacuum to a dust filter separator. The pellets receive a final cleaning in a secondary air wash deck before exiting the unit via another flux field generator.

The company's dedusting technology can ensure the removal of particles smaller than 1 µm, says Paulson. Buyers of resin are becoming more and more demanding, he notes. "Ten years ago, 500 parts per million (ppm) of fines was acceptable. Five years ago, it was 200 ppm. Now, it's down to 100 ppm, and some are looking at 50 ppm," Paulson explains. Pelletron's line of equipment achieves levels of 25 and even 10 ppm, he adds.

Optical-grade parts molders stand to benefit greatly from the technology. Materials such as clear acrylics, polycarbonates, and ABS are unforgiving when it comes to the presence of fines, fluff, and streamers. Scrap rates as high as 90% have been reported, according to the company. On the Pelletron Web site, contract molding firm Nypro describes the problems it had encountered molding clear medical parts in acrylic and crystal styrene materials.

Black specks were appearing in both materials, but the contamination was especially acute with the styrenic polymer. The material was plagued by fines, because it is typically moved four to five times prior to processing. The movement causes friction, and as the pellets bump against each other, they create dust particles. To remedy the situation, the company mounted a deduster on top of a drying hopper. Fines burning in the styrene ceased immediately, according to Nypro, and the black specks were eliminated in almost every shot.

Pelletron offers 12 different models of dust removers, with processing capabilities exceeding 200,000 lb/hr. With a capacity of 150 lb/hr, the P1 Mini-Deduster is the instrument of choice for small to medium-size medical device molders and extruders, according to Schneider. It is designed to fit above the feed throat of an injection molding machine or extruder, or at the inlet of a drying hopper. The fan and dust collector are remotely located to keep the equipment stack as small as possible. A specially designed agitator limits the product flow through the Deduster to prevent exceeding the rated capacity. This allows the P1 to be choke-fed from a vacuum loader. A window on the unit allows the operator to monitor the operation. The P1 can also be installed off-line as a regrind or scrap recovery system. A version with a cast body was introduced in October.

The firm also recently launched a redesigned P5 unit. Designed for small to medium-size plastic product manufacturers, the equipment is reportedly one of the few dust removal systems able to clean regrind and virgin materials that have been mixed together. It has a capacity of 500 lb/hr.

Bearing-Grade PEEK Introduced

A dust removal system from Pelletron Corp. was made for small to medium-size manufacturers
of plastic products and can process up to 150 lb
of raw material per hour. Its use can dramatically reduce scrap.

A bearing-grade PEEK material is suited for applications where high load, chemical and high-temperature resistance, and low wear are desirable properties. In the medical and pharmaceutical sectors, Amiloy 22 can be used to fabricate shaft bushings, bearings, piston rings, pump parts, and slide pads.

Available from Amicon Plastics, the material's internal lubrication eliminates the need for external lubricants and greases, thus allowing its use in dynamic parts in cleanroom environments. Tribological characteristics and wear resistance also benefit from this property. Amiloy 22 withstands temperatures up to 500°F, is corrosion resistant, and has a low moisture absorption rate. Additional features include dimensional stability and mechanical strength.

Medical Technical Polymers

Five new grades of polyphenylene sulfide (PPS) and eight grades of liquid-crystal polymer (LCP) for medical device, drug packaging and delivery, and other healthcare applications were recently introduced by Ticona. The materials provide a wide range of design and processing options.
Filled and unfilled grades are available for injection molding and extrusion, as well as grades with various flow properties and additives that render parts exhibiting low friction and wear, desirable surface appearance, enhanced stiffness, and other special properties. Compliant with USP Class VI biocompatibility standards, Fortron MT grades of PPS offer good dimensional stability, toughness, and rigidity; can tolerate repeated sterilization; and resist hydrolysis and the effects of most chemical media. They include glass-fiber-reinforced grades. Vectra MT grades of LCP provide strength, stiffness, creep resistance, dimensional stability, and high flow in long, thin sections. In addition to an unfilled grade for medical packaging, this family of thermal- and chemical-resistant polymers includes versions with glass-fiber, carbon-fiber, and mineral fillers for enhanced performance attributes. 

Copyright ©2003 Medical Product Manufacturing News

Printing, Labeling,and Marking

Originally Published MPMN November 2003

EQUIPMENT NEWS

Printing, Labeling, and Marking 
The D-I-D system from West Pharmaceutical Systems applies differentiating text and images to drug-container closures.

Printed Vial Closures Distinguish Products and Manufacturers

West Pharmaceutical Systems Inc., a producer of pharmaceutical-container closure systems, has developed a printing-based seal system that can be used to convey information and provide protection. The D-I-D decoration, identification, and differentiation system employs ink-jet printing and imaging to differentiate products and companies clearly. Users can label a vial closure with an identification of contents, a brand name, a dosage indication, or a characterization of the strength of the medicament. Non-human-readable UV ink can be used for lot and date coding. In addition, the innovative system has utility as a mechanism for protecting against drug counterfeiting. 

West Pharmaceutical Systems Inc., 101 Gordon Dr., Lionville, PA 19341.


Bar Code Label Design and Printing System Supports 21 CFR Part 11 Compliance

Compliance with the FDA electronic recordkeeping regulation can be achieved with EasyLabel 5 from 
Tharo Systems.

The new release of a software system for designing and printing labels and bar codes, available from Tharo Systems Inc., includes a collection of tools for 21 CFR Part 11 electronic recordkeeping compliance. The EasyLabel 5 Platinum bar code labeling and product identification system features new password and user options, logging options, and format choices that help a company to set up a compliant labeling system.

EasyLabel 5 offers several other additions designed to facilitate label generation and printing. The new EAN/UCC-128 wizard makes the creation of these codes a simple four-step process. By supporting Microsoft's ActiveX Data Objects, the software provides a fast, productive means of accessing numerous different data sources. 
A new database editor employs Microsoft's OLE DB to allow users to view and edit nearly any database from inside the system. 

Tharo Systems Inc., 2866 Nationwide Pky., Brunswick, OH 44212.


Pad- and Screen-Printing Machines Are Semiautomatic, Versatile 

A two-color pad printer from Impression Technology USA features 
sealed ink 
cups.

A full line of semiautomatic pad-printing and screen-printing equipment is available from Impression Technology USA, the North American distributor of machines manufactured by the Australian company Impression Technology Pty. Ltd. The TIC line comprises 45 models ranging from single-color tabletop machines to six-color floor models. Pictured is the Model TIC 183 SCDE two-color pad printer with sealed ink cups.

The distributor also carries all necessary supplies for the machines, which are all suitable for imprinting a wide 
variety of products, including medical devices. 

Impression Technology USA, 405 Commerce Ct., Vadnais Heights, MN 55127.


Hot-Foil Stamping Machines Provide Exact Images in Continuous Use

Economical hpdPrint hot-foil stampers from Griffin-Rutgers can 
be integrated easily into packaging and labeling lines.

A range of coding and marking systems using stamping foil is offered by distributor Griffin-Rutgers Company, Inc., to provide exact print images of high quality on almost all material substrates. The Metronic line of miniature, modular, compact, and cassette hpdPrint hot-foil stamping units are designed for continuous daily use. Featuring a high level of function, good reliability, and easy integration into form-fill-seal machines, labeling systems, and packaging machines, the systems operate simply and economically.

Print areas range from 10 ¥ 30 to 50 ¥ 80 mm. All printed images are immediately abrasion- and smudge-proof 
and resistant to environmental influences. The safe, emission-free color pigments can be used on delicate products.
The Metronic hot-foil stamping units have infinitely variable controls, electronic temperature control, adjustable time delay and impulse stop, and a secure cliché-locking system. They can be customized with a wide variety of options and accessories.
 
Griffin-Rutgers Company, Inc., 25 Trade Zone Ct., Ronkonkoma, NY 11779.


Thermal Printers Offer High Performance for Portable Applications

Choices abound with 
the new-generation MCP8000-series thermal printers from Martel Instruments.

A series of portable thermal printers from Martel Instruments provide reliable performance and a choice of communications interfaces and power sources that make them suitable for nearly every application requiring 
a compact printer. All models of the MCP8000-series printers are housed in an ABS plastic enclosure and incorporate a fixed-head print mechanism. They provide high-speed, high-resolution printing and quiet, maintenance-free operation. The highly reliable devices have applications in portable medical analyzers and industrial test equipment.

Communications interfaces available with the printers include cabled RS-232 or 3.3-V logic, a variety of infrared options, and wireless communication via Bluetooth. Nickel-metal hydride cells allow continual charging without memory effect. Other power choices are alkaline cells, external 5-V dc, and vehicle supply power.

Many different modes of printer operation are possible, including numerous character sets such as Aerial, Roman 8, and ECMA 94; print-density and current-consumption control; sleep mode; character scaling; and bar code printing. Any product feature can be customized to suit specific application requirements.

Martel Instruments, Stanelaw Way, Tanfield Lea Industrial Estate, Stanley, Co. Durham DH9 9XG, United Kingdom.


Rapid-Throughput Laser Coder Produces Permanent High-Resolution Marks

High-resolution permanent marks can be produced on a diverse range of materials with a laser coder offered by Weber Marking Systems Inc. The e-Solarmark vector laser coder is capable of marking as many as 1000 characters per second at product delivery speeds to 560 ft/min, and coding substrates as various as paper, paperboard, foils, plastics, glass, coated metal, and many other materials. The rugged laser system is well suited for both dynamic and static applications.

The e-Solarmark provides text as small as 0.020 in. high. It can also mark numerous bar code symbologies and eye-catching graphic images. A choice of lenses is available to deliver marking fields ranging in extent from 2.0 to 7.8 in. square.

The easy-to-install laser coder is essentially maintenance free and requires no consumables to effect product or package marking. It comes with its own controller and PC-based software. 

Weber Marking Systems Inc., 711 W. Algonquin Rd., Arlington Heights, IL 60005.

Ink-Based Code-Marking Machines Can Be Washed Down

Code-marking machines 
from Sprinter Marking can 
be constructed 
of corrosion-resistant components.
 

The complete line of automatic ink-based code-marking machines from Sprinter Marking Inc. is offered with washdown capability. Standard machines are modified by the addition of corrosion-resistant parts at nominal extra expense, eliminating the problem of rust in production environments requiring regular steam cleaning or sterilization of processing equipment.

Eight standard models of the code-marking machines are available, which can be fitted with extended-width or extended-stroke marking heads and are supplied as complete benchtop systems. The machines produce alphanumeric or symbol codes on porous or nonporous flat, stationary surfaces of paper, metal, or plastic. Inks that dry typically in 1 second or less can be changed easily owing to the quick-change design of the reservoir; all basic colors, including white, are available. The sealed ink system allows discontinuous operation with no fluctuation 
in the quality of impressions. The marking head also is easily removable, facilitating message changes.

Mountable in any orientation, the smooth operating systems range in weight from 4 to 18 oz and offer marking speeds of 150 to 350 codes 
per minute. The manufacturer supplies all basic, optional, and auxiliary equipment, along with supplies for normal code-marking operations. 

Sprinter Marking Inc., 1805 Chandlersville Rd., Zanesville, OH 43701.

Thermal-Printer Mechanisms Provide Reliable Long-Term Performance

FTP-607MCL103/383-series printer mechanisms from Fujitsu Components America offer high speed and long life.

A series of lightweight, compact 24-V high-speed thermal-printer mechanisms are offered by Fujitsu Components America Inc. for use in medical equipment, test and measurement systems, and other applications. The durable FTP-607MCL103/383 series includes 2- and 3-in. die-cast metal mechanisms and optional automatic cutters. Both printer mechanisms have a maximum variable print speed of 100 mm/sec and print at a resolution of 8 dots per millimeter.

The 2-in. printer measures 86.9 ¥ 33.1 ¥ 66.3 mm and weighs 240 g with mounted cutter. The 3-in. printer with cutter is 105.7 mm wide and weighs 275 g. Both accommodate paper stock 60-100 µm thick and feature the patented Easy-Load model platen-removal system that facilitates paper loading and printer maintenance. They are available with optional RS-232-C or parallel interface boards, as well as with a large-scale integrator for customers designing their own controller.

The series is well suited for applications requiring reliable performance over the long term. The mechanisms have a head life rated at 500 million pulses or 50 km of paper. They operate within the temperature range of 0° to 50°C. 

Fujitsu Components America Inc.
, 250 E. Caribbean Dr., Sunnyvale, CA 94089.


Digital Technology Facilitates Customized Short- to Medium-Run Labels

Customized digital labeling is available from Labeltronix. The company can produce labels for products of all shapes and sizes, with various designs and with customized content. The digital process enables high-quality custom labels with variable data to be generated quickly and efficiently in short to medium runs.

Labeltronix can produce just-in-time labels by means of 1-, 4-, and 6-color processes. Customers can change expiration dates, graphics, and other elements from their own computers. 

Labeltronix, 1097 N. Batavia St., Orange, CA 92867.


Copyright ©2003 Medical Product Manufacturing News

Pumps and Valves

Originally Published MPMN November 2003

SPOTLIGHT

Pumps and Valves

Swing-piston compressor

Rated at 15 L/min, a swing-piston compressor is available for use in medical equipment such as nebulizers and suction apparatus, and as a pneumatic air source. The 5-in.-long NPK09 features a brushless dc motor, and generates 100 psi of pressure and vacuum to 27 in.Hg. Suitable for portable applications, the product's speed control, speed signal, and logical on-and-off features enable integration into system logic. KNF Neuberger Inc., 2 Black Forest Rd., Trenton, NJ 08691.


Plug valves

A company offers a variety of plug valves. The wetted paths are made of chemically inert Teflon and Kel-F materials rated at 100 psig or less. The valves can be used as stand-alone devices, or certain models can also be panel mounted. 
The valve position is controlled manually via a handle attached to the valve stem. Connections are via 1¼4-28 UNF-SB
fittings. Hamilton Co., 4970 Energy Way, Reno, NV 89502.







Plastic-body valve

A bidirectional, barbed, plastic-body valve is constructed with Bay blend FR110, acrylonitrile butadiene-styrene, and polycarbonate materials. The 2X1958 is offered as part of the company's series of two-way normally closed valves. With 
a 1¼8-in. orifice, the component hasa coefficient of variance of 0.245, a maximum psi of 30, and a power rating of 7 W. Norgren-Kip Fluid Controls, P.O. Box 468, Farmington, CT 06034.






Vacuum pumps

A range of vacuum pumps uses technology that emphasizes modularity and efficiency, with a compressed- air-driven module at its core. Using the company's Coax technology, the P3010 pump module is clipped into a click-in strip that can handle up to four pumps without tools. Designed for easy maintenance and installation, the products are 0.65 in. wide and weigh 3 oz. The pumps can create a vacuum pressure as low as 27 in.Hg at 45 psi inlet pressure. With no moving parts, the component holds the noise level down to 66 dBa. Piab Vacuum Products, 65 Sharp St., Hingham, MA 02043.




Check valves

One-way check valves are available with barbed and straight fittings in many sizes. A company's proprietary design of the internal discs of the valves ensures that they open at a very low pressure (less than 2.5 in. of water). The units, made of medical-grade acrylic and silicone, are 100% tested to ensure that backflow is not possible even at very low back pressure. The valves can be sterilized with EtO or radiation methods. Steam-autoclavable check valves are available on special request. Miniature valves with male and female luer ends are also offered. Resenex Corp., 9614 Cozycroft Ave. #F, Chatsworth, CA 91311.


Diaphragm pump

A diaphragm pump enables high-precision dosing in the nanoliter range for many aggressive media including organic and inorganic solvents. With a PEEK body and perfluoroelastomer seals, the Type 7604 micropump has a fluid temperature range of 50° to 140°F, with a maximum pressure at 2.9 psi. The product's fluid flow rate reaches up to 4 ml/min with a 40-Hz maximum pump frequency allowing a pulsation-free flow. With a width of 11 mm, the unit can be mounted with standard bodies configured for surface-mount or tube connections. Applications include microdosing, probe preparation, syringe and peristaltic pump replacement, and lubricant dosing. Burkert, 2602 McGaw Ave., Irvine, CA 92614. 




Robotic fluid-dispensing system

A provider of precision fluid-control solutions offers a system delivering accurate liquid dispensing for automated manufacturing and laboratory procedures. Suitable for robotic fluid-dispensing and fluid-spotting applications, the Model 
2-4 system can be directed by the company's PC-controllable RS-485 communication. With an accuracy of up to ±0.05 coefficient of variance, the equipment provides pumping capability with positive-displacement devices, fluid measurement, and flow control. Encynova, 557C Burbank St., Broomfield, CO 80020.


Disk valve

A disk valve handling water flow of 550 ml/min at 1 psi features a positive shutoff to eliminate backflow. This makes the product virtually leakproof. The latex-free product can withstand 60 psi of back pressure and less than 0.25 psi of crack pressure. With a silicone seal disk in a polycarbonate housing, the valve is available in a variety of tube-end and luer-connection configurations. Halkey-Roberts Corp., 11600 9th St. N., St. Petersburg, FL 33716. 

Copyright ©2003 Medical Product Manufacturing News

Disposables

Originally Published MPMN November 2003

SPOTLIGHT

Disposables

Fluid disposable outsourcing

A company supplies outsourcing solutions to medical device companies, focusing on proprietary OEM products and private-label fluid disposables. 

The vertically integrated company's capabilities include design engineering, program management, production, cleanroom molding and assembly, and packaging and sterilization management. Additional services include tubing and wire fabrication and machined components. UTI Corp., 200 W. 7th Ave., Collegeville, PA 19426.




Ostomy adhesives

Integrated hydrocolloid wound-care and ostomy products incorporate a translucent adhesive that reduces breakdown resulting from sterilization and heavy fluid absorption. Alginates in the adhesive stabilize the fluid-handling properties while providing sodium and calcium ion exchange at the wound bed. Individually formulated for the different environments of colostomies and ileostomies, the products are available in a variety of configurations, including island patches. The adhesives are manufactured in an ISO 9001-certified facility that meets GMP and quality system requirements. GriggSmith Industries, 1080 University Blvd., Richmond, IN 47374


Molded IV accessories

A line of molded IV components includes male and female luer adapters, stopcocks, check valves, single- and dual-flow piercing devices, barbed connectors, and burette chambers. The list of products to complement IV sets also includes clamps, caps, y- and t-fittings, tri-connectors, and custom designs. Most components are available in a variety of sizes and configurations. B. Braun OEM/Industrial, B. Braun Medical Inc., 824 12th Ave., Bethlehem, PA 18018. 




Molded plastic components

An ISO 9001- and ISO 13485-certified manufacturer offers Class 100,000 cleanroom production of medical molded plastic components and subassemblies. Disposable products range from connectors to packages sterilized with EtO, and include luers, clamps, filters, and extension sets with needle variations. The company can make different subassemblies with its own components, outsource accessories, or work with customer-consigned parts. Innovative Medical Manufacturing Co., No. 62-5, 6 Lin, Kung-Kwaung-Zei, Kung-Kwaung Li, Chu-Nan Cheng, 
Maoli Hsien, Taiwan 350, Republic of China.



Disposable-product manufacturing

A single-source supplier of precision disposable products uses electric, servo-driven process equipment to provide cleanroom injection, insert, multishot, and blow molding. The company's capabilities include product design, precision rapid-turn tooling, multicavity tooling, and mold debugging and optimization. Cleanroom molding with processing 
of commodity and engineering resins, including polylactide and fluoropolymers, and cleanroom assembly and secondary operations are also offered. Infinity Plastics LLC, 6020 Nicolle St., Ventura, CA 93003.






Nonwoven wipers

Produced from a continuous filament fiber, nonwoven wipers exhibit low fiber and particulate residues and high absorbency. The products are offered in a variety of sizes and styles, and can be made sterile or presaturated with various cleaning and disinfecting solutions. The company also manufactures a line of knit textile wipers, including Captura and Matrix nonwovens, CleanSorb tubular mops, and MilliMoist presaturated wipers. Milliken & Co., P.O. Box 1926, 
M-153, Spartanburg, SC 29304.




Adhesive tape

An array of double-coated and single-coated adhesive tape products accommodate needs ranging from electrode adhesion to surgical drapes. Available for small-run specialty die-cutting or in large quantities on standardized rolls, the products are converted and readied in an ultraclean environment. True Tape LLC, 11012 Oaktree Park, San Antonio, TX 78249.

Copyright ©2003 Medical Product Manufacturing News

Optical Scanning Tool Performs 100% Stent Inspection

Originally Published MPMN November 2003

PROFILE

Optical Scanning Tool Performs 100% Stent Inspection

Automated system reduces potential for human error

Joyce Laird

The FineScan takes a finely detailed image of the stent, any part of which can then be automatically inspected.

It has been said that any type of quality control (QC) procedure relying on operator expertise is only 80% accurate. When the device being inspected is something as critical as a stent, however, a 20% error rate is not acceptable. A contract stent manufacturer, seeking to add value to its OEM services, found an optical inspection instrument that not only reduced the potential for human error but also substantially accelerated the QC process.

Laserage Technology Corp. (Waukegan, IL) manufactures precision tubes, including stents, connectors, and various other items for medical device OEMs. The company typically accommodates 20 to 60 individual jobs with lot sizes ranging from 50 to more than 5000 per production run. "We need to inspect as-cut stents using approved and validated procedures as required by FDA and our customers," notes business unit manager Dan Capp.

As stents decrease in size and cutting patterns become more intricate, conventional optical equipment is not always up to the task of adequately inspecting the products. Laserage had been using optical comparators, tool microscopes, and automated CNC vision systems. These tools require a high level of operator expertise. Standard automated optical systems with a camera use a stepping process to take multiple small photo segments; the engineer must write fairly complex CNC inspection routines and then piece together the images like a jigsaw puzzle to complete a full stent inspection. While this technique is acceptable for some of the larger stent diameters, it lacks the repeatable accuracy required to inspect extremely small stents or those with intricate patterns. It also is not suited for performing a 100% point inspection. Because the instrument requires considerable operator expertise, labor costs can be significant and there is potential for human error.

Sourcing speed and accuracy

In sourcing a new inspection tool, Laserage identified speed, accuracy, and fast changeover capability as key criteria. The ability to offer its customers 100% inspection of the product--performing thousands of measurements at once as opposed to having an operator look at a handful of critical points--was also an attractive proposition. The FineScan system from Visicon Inspection Technologies (Napa, CA) fulfilled these requirements.

The system comprises a high-resolution digital camera, rotating gem spindle, light source, and proprietary software bundle. Once the unit has been programmed, the inspection process is fully automatic with the exception of the loading and unloading of the stents. All inspection data are saved within the system software.

"We take a single scan and from that we look at the entire image, using pattern matching to do inspections. What used to take minutes, now takes seconds," says Dan Freifeld, president of Visicon.

How it works

The operator places the stent over a transparent mandrel. Light is projected through the stent, which is automatically rotated 360°. The camera, mounted above the mandrel assembly, takes photos of the part as it spins underneath, producing a finely detailed and perfectly registered digital image. Gauges programmed by the user tell the system software which points require inspection. The system can be programmed to perform inspection routines on a single location or the entire device pattern. The inspection data are output in a table format, which can be exported to Excel or SPC programs.

Capp concedes that learning the mechanics of the FineScan system and programming it was no walk in the park. "It's a challenge," he says. "The most critical parts are getting the lighting right, especially for very small stents with dense patterns, and teaching the program to locate the gauges," says Capp. Gauges are used by the software to find all of the image points that require inspection. The system can be programmed to perform inspection routines on one location or the entire device pattern. Once you get the software gauges set for a particular design, adds Capp, "the reproducibility and ability to measure a huge quantity of parts is excellent." While the learning curve is steep, the process is quite straightforward once the operator has been properly trained, according to Capp. "The software basically runs off standard Windows templates, so it is just a matter of learning to apply the custom interface tools."

When the programming has been completed, "it doesn't matter if the FineScan is inspecting five or 5000 points," says Capp. "Mechanically, all that the system is doing is taking a picture. The inspection gauges are applied to the picture within the software, and it all happens simultaneously in computer processing time."

Added value

Bitmap files created using the FineScan system can be e-mailed to customers as stent design issues arise.

Laserage has benefited from the system's speed as well as the ease with which on-the-fly changeovers can be made. Being able to offer OEMs the capability of taking thousands of measurements in less than a minute with 100% accuracy adds substantial value to the company's services, adds Capp. "One plus that I didn't expect is that I can use the digital output from the FineScan as a descriptor," says Capp. "I put images into procedures and e-mail them to customers to show them specific areas of concern in their design. I don't know of any other inspection system that can provide a detailed digital image of the entire stent surface," says Capp.

Some Laserage customers want every stent to be inspected using the FineScan. For many OEMs, however, the instrument is especially valuable as an audit device, says Capp. A representative lot of stents is thoroughly inspected on the FineScan, while the rest are subjected to a standard optical inspection. Everything receives a lot number, and the data are provided to the client for product validation.

Laserage Technology also uses the data generated by the FineScan for its own process control. "The data we get from in-process measurements are plotted on a statistical process control chart," says Capp. "This tells us if there is a trend that could be affected by our production equipment."

Laserage Technology continues to use other optical inspection equipment for less complicated jobs. "But for large orders of 5000 or 10,000 parts per month and when our customers want [complete] supporting data, we use the FineScan," says Capp. "It saves time and gives us a new service to offer our customers."


Copyright ©2003 Medical Product Manufacturing News

Web Sites Streamline Polymers Research

Originally Published MPMN November 2003

E-NEWS

Web Sites Streamline Polymers Research

Two on-line tools are making it easier for engineers to research polymer properties and applications. Omnexus (Atlanta, GA) has launched www.omnexus.com/materialdata center, where users can access the properties of more than 8000 grades of plastics. Material matters also can be explored in depth at a site hosted by Knovel (Norwich, NY). At www.knovel.com,  more than 500 plastics and engineering reference books can be searched on-line.

Click to go to site.

The Omnexus Material Data and Applications Center compiles data representing nearly 80% of global plastic products from more than 35 suppliers. Developed in collaboration with German firm M-Base Engineering + Software, the site also features an applications section. 
Users can search by industry segment, including healthcare, and by polymer type. Datasheets involving hundreds of material applications can be downloaded. Materials can be searched based on 210 different properties in English or German. SI or English units of measure can be selected.

Omnexus was founded in June 2000 by Bayer, BASF, Dow, DuPont, and Ticona to serve as a platform for e-commerce in the plastics industry. More than 20 companies worldwide are currently represented.

On the literary front, Knovel has converted hundreds of plastics and engineering reference books into a searchable Web-based resource. Interactive tables, graph digitizers, equation plotters, and other tools can be manipulated and used for analysis. "We have turned 'dumb' graphs into smart graphs," says chairman and editor-in-chief William A. Woishnis. "For example, users can select data points from the graphs and export them to spreadsheets."

Click to go to site.

Publications that can be accessed on-line include the Modern Plastics Handbook, Chemical Resistance of Plastics and Elastomers, and Roark's Formulas for Stress and Strain.

The company plans to introduce a medical device subject area by the end of 2003, according to Woishnis. 

Norbert Sparrow

Copyright ©2003 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN November 2003

E-NEWS

My Favorite Bookmarks

Bill Bulman 
Director of Quality and Operations
Promold Plastics

American Production and Inventory Control Society (www.apics.org) is a training organization providing seminars, conferences, and manuals on production and inventory control. APICS has chapters located nationwide, with five in Connecticut. Its site is a great resource for planners, buyers, material managers, operation managers, production control managers, and warehouse supervisors. It also offers certification preparation in integrated resource management and production and inventory management. 

American Society for Quality (www.asq.org) also provides training and manuals and answers technical questions on quality. Its staff is available to help you find a resolution for any questions you may have on quality standards or procedures. ASQ also offers certification programs for quality engineers, quality managers, and quality auditors. The local chapters have monthly meetings, which usually feature speakers knowledgeable in disciplines such as statistics, lean manufacturing, and six-sigma certification. 

Cnet (www.cnet.com) is a consumer guide to technical information on computers, printers, and other things you would need for your office. There are a lot of suppliers advertising as well. People who have used the Web site give ratings from 1-10 on the products they have bought, and also list reasons for their scores. The Web site lets consumers compare different models and prices.

Hotjobs (www.hotjobs.com) and Monster (www.monster.com) are great because people post résumés on them, and employers can advertise positions. It simply makes good business sense to utilize such resources. They are valuable tools, and have helped us reduce expensive recruitment costs.

Promold Plastics (Cromwell, CT; www.promoldplastics.com ) is a custom injection molder and a mold maker with more than 35 years of experience. The company, which is ISO 9001:2000 certified and UL recognized, serves the medical and electronics industry nationwide. 

Melody Lee

Copyright ©2003 Medical Product Manufacturing News

Renewable Antimicrobial Coating Protects Medical Textiles

Originally Published MPMN November 2003

INDUSTRY NEWS

Renewable Antimicrobial Coating Protects Medical Textiles

Bacteria from untreated wipes are shown next to samples treated with Vanson HaloSource's HaloShield coating.

Hospitals strive to maintain a sterile environment, but with constant traffic of illness and disease, protective measures to keep the facilities clean may not always be enough. To enable medical facilities to keep their bedding and garments bacteria free, bioscience company Vanson HaloSource (Redmond, WA; www.vanson.com) teamed up with medical product and equipment supplier Medline Industries (Mundelein, IL; www.medline.com) to apply an antimicrobial protective coating to these products. HaloShield N-halamine combats mold, antibiotic-resistant bacteria, and contagious viruses, which are carriers of diseases among hospital patients and healthcare personnel. 

"HaloShield coatings extend the power of chlorine allowing product manufacturers to turn virtually any surface--from a cotton sheet to a tile floor--into a durable antimicrobial surface," says Jerry Wetherbee, CEO of the company. "On an untreated fabric, chlorine and its antimicrobial power simply evaporate as soon as it leaves the washing machine, allowing new contaminants to grow freely. We think of HaloShield as Velcro for chlorine molecules. It locks the chlorine in place until it comes into contact and kills the microbe."

According to the company, the coating stays on the treated surface for the life of the item. Washing in common household bleach resets the chlorine on the coated fabric. The power of the chlorine retains its virus-killing abilities for several weeks between regular launderings. Laboratory and field tests show that HaloShield is nonirritating and safe for sensitive skin, even with fabric worn or slept in daily. 

When searching for a fabric to help prevent bacterial infections, "we looked at every antimicrobial treatment available and found that only HaloShield deals effectively with antibiotic-resistant bacteria, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci, as well as the growing threat of viruses, including HIV," says Ron Barth, president of Medline's Medcrest textiles division. 

Later this year, the company will release Fabri-Kote, its HaloShield-treated hospital sheets, pillowcases, scrubs, and gowns. Medline's clients include hospitals, extended-care facilities, and surgery centers nationwide. Vanson HaloSource also produces the Hygieni-Kote coating for hard surfaces and Poli-Kote for paints. 

Melody Lee


Copyright ©2003 Medical Product Manufacturing News

Reinforcement Material Receives Innovation Award

Originally Published MPMN November 2003

INDUSTRY NEWS

Reinforcement Material Receives Innovation Award

W. L. Gore's award-winning staple line reinforcement material resorbs within six months after surgical procedures. 

Extensive changes and improvements to the Seamguard bioabsorbable staple line reinforcement material earned W. L. Gore (Flagstaff, AZ; www.goremedical.com) the Innovation of the Year award. Given by the Society of Laparoendoscopic Surgeons (SLS) at its congress and expo in September, the award recognizes the product's ability to retain measurable strength for 30 days postprocedure before completely resorbing within six months.

"This product used to be made from Gore-Tex material, which was permanent, thick, and hard to use with staples," says Fred Walburn, W. L. Gore's product specialist. "If you ask surgeons what they want, they will say that they want something that performs the function and then disappears when the job is done. So that's what we did. The product now resorbs instead of staying permanent." 

The 0.25-mm-thick material contains a bioabsorbable membrane formed into a sleeve with the use of a polyester braided suture. Its minimal profile fits nearly any trocar, and a pull-cord deployment keeps it firmly in place until the tissue manipulation is complete. Used in surgical procedures, the material reinforces staple lines on the lung, stomach, and bowel or mesentery in tissue transections or resections. 

The product is composed of bioabsorbable polymers used in sutures, surgical meshes, and implantable devices. Made from synthetic material, Seamguard does not carry the risk of animal-source contamination.. 

Melody Lee

Copyright ©2003 Medical Product Manufacturing News