Absorbable Biomaterial Is Suited for Diverse Applications

Originally Published MPMN October 2001

Absorbable Biomaterial Is Suited for Diverse Applications

Melt extruded from Tepha Inc.'s PHA4400 biosynthetic material, this monofilament is strong and flexible.

Offering flexibility, pliability, and absorbency, a biosynthetic material from Tepha Inc. (Cambridge, MA; www.tepha.com) can be used in a range of medical device and tissue-engineering applications. "Most biosynthetic materials used today were originally developed for sutures," says president Simon Williams. "While they are suitable for that function, they often do not have the optimal properties for the many other applications to which they've been adapted."

Tepha's new PHA4400 polyester material meets the broad requirements of these other uses by offering a wide range of physical capabilities. The elastomer can be processed into most shapes using melt or solvent processes. It liquefies at temperatures of 50°–180°C and has a tensile strength of 20–90 MPa in its unoriented form. Other benefits include high elongation before breaking and the formation of nonacidic degradation by-products. Among its many applications, PHA4400 can be used in surgical meshes, nerve guides, skin-substitute patches, heart valves, stents, grafts, internal fixation devices, and bulking agents. The material is also suitable for sutures.

Zachary Turke

Copyright ©2001 Medical Product Manufacturing News

Jerneen Micro Medical Technologies to Become Synovis Interventional Solutions

Originally Published MPMN October 2001

Jerneen Micro Medical Technologies to Become Synovis Interventional Solutions

Microcoiling is one of the services provided by Synovis IS, formerly Jerneen Micro Medical Technologies.

Bio-Vascular Inc. (St. Paul, MN; www.biovascular.com) has announced that Jerneen Micro Medical Technologies (Lino Lakes, MN; www.jerneen.com), a wholly owned subsidiary, has changed its name to Synovis Interventional Solutions Inc. Synovis IS provides product-development resources and high-volume manufacturing support necessary for the rapid commercialization of new interventional technologies. "The decision to call ourselves Synovis Interventional Solutions grew out of the desire and need to have a name that is more representative of the actual business of the company, which has evolved significantly since we acquired it in 1998," says Bio-Vascular president Karen Gilles Larson. "The name Synovis is derived from synergy, innovation, and vision."

Synovis IS is focused solely on the field of interventional medical devices and related components, including pacemakers, defibrillators, and neurostimulation devices. Services include microcoiling, precision grinding, wire straightening, wire forming, materials sourcing, assembly and packaging, and new product development. The company is currently developing a range of complementary products to increase the value of its manufacturing processes.

Katherine Sweeny

Copyright ©2001 Medical Product Manufacturing News

Solid-Imaging System Operates in Standard and High-Resolution Modes

Originally Published MPMN October 2001

EQUIPMENT NEWS: Rapid Prototyping Equipment

Solid-Imaging System Operates in Standard and High-Resolution Modes

Machine recently made available for commercial use

A new solid-imaging system incorporates the versatility of stereolithography via a dual-mode laser to reduce the design iteration cycle and perform secondary tooling applications. The Viper si2 SLA system allows the user to choose between standard-resolution and high-resolution modes during part preparation to maximize the machine's functionality and effectiveness. The machine can build accurate parts with a smooth surface finish and thin, vertical walls. The system was originally released to users for testing purposes; their comments have led to additional system refinements. Now commercially available, the Viper si2 is intended for use in specialized applications such as medical devices and electronic components.

The Viper si2 SLA from 3D Systems Corp. is suited for making prototypes of syringes, diagnostic kits, and other detailed medical devices.

Since unveiling the Viper si2 SLA in March, 3D Systems Corp. has enlisted customers to participate in a product testing program. Data collected during testing was used to make improvements to the Viper system before it became commercially available in July. "The Viper si2 system has the ease of use of a larger SLA machine on a smaller platform," says Rob Connelly, president of FineLine Prototyping, a test site for the new system. "We are able to use this system to produce a variety of highly detailed medical devices such as syringes, diagnostic kits, and parts with small flow channels," he adds.

The Viper si2 system offers a range of solid-imaging applications. The user can choose between standard-resolution mode for a balance of speed and part resolution, and high-resolution mode for detailed small parts and features. An integrated processor-controlled high-speed scanning system has a solid-state laser that delivers 100 mW of available power at a 354.7-nm wavelength. Standard spot size is 0.01 in. ± 0.001 in.; high-resolution spot size attains 0.003 in. ± 0.0005 in. The system builds parts with a smooth surface finish, good optical clarity, and high accuracy, as well as thin, straight vertical walls. Parts weighing up to 20 lb can be formed at speeds up to 0.2 in./sec.

Optimized for the company's Cibatool SL materials, the high-throughput system comes equipped with upgraded versions of 3D Lightyear part preparation and Buildstation control software. It also features a fast scanning system, interchangeable vat, and a choice of materials. Additional vats, build platforms, and postcuring equipment are available as options. Applications include small to medium-sized models and prototypes, patterns for injection molding and investment casting, precision builds of detailed parts, and detailed part fabrication.

Machine creates testable models from polycarbonate, ABS, and sulfone

The FDM Titan from Stratasys Inc. creates polycarbonate models that have impact strength and heat resistance properties.

A rapid prototyping machine creates models using high-performance engineering materials such as polycarbonate, ABS, and sulfones, which exhibit characteristics for functional testing. Available from Stratasys Inc., the FDM Titan can build models from each of the three materials, minimizing changeover steps. "Many of today's plastic products are composed of polycarbonate, ABS, polysulfones, or blends of these," says president Scott Crump. "The Titan was developed in response to users performing more demanding functional tests on their prototypes." These materials offer impact strength, flame-retardant qualities, strength at high temperatures, sterilization capabilities, and resistance to oils, gasoline, chemicals, and acids.

Models measuring up to 5 in. are accurate to within ± 0.005 in. Accuracy on models larger than 5 in. is ±0.0015 in.

Applications include concept modeling, prototype development, casting, and concurrent engineering. The system's platform permits upgrading to other materials, such as a polycarbonate/ABS blend that will be available in the future.

The FDM Titan does not require special facilities or venting and does not involve the use of hazardous materials or the release of by-products. It operates on the company's Insight software, which uses a Windows NT platform.

Milling machine offers generous work envelope and compact footprint

The M4 milling machine from Datron Dynamics Inc. features an automatic tool changer and tool-length offset sensor.

A milling machine is suitable for small-part manufacturing of medical devices. The M4 system, offered by Datron Dynamics Inc., features a 60,000-rpm spindle, a 16 x 15 x 7-in. work envelope, and a 60 x 38-in. footprint. An automatic tool changer and tool-length offset sensor enable unattended operation and provide quick and easy set-up for the operator. Automatic tool-length measurement operating software is PC-based and allows the system to interface with many CAD/CAM software packages, resulting in quick turnarounds of rapid prototype models or short-run production molds. An easy-to-use control interface requires two to three days of operator training. Capable of milling, drilling, tapping, and engraving, the machine has feed rates up to 475 in./min. An integrated spray mist coolant system minimizes the need to deburr or degrease surfaces. Applications include production of EDM electrodes, hot stamping and embossing dies, 3-D mold making, rapid prototyping, and 3-D precision engraving. Options include a z-height correction sensor, pneumatic and vacuum clamping systems, EDM electrode clamping systems, 9- or 18-tool changers, a microdrop oil coolant system, and programmable RPM control software.

Laser sintering system features increased speed and productivity

A selective laser sintering system allows users to turn CAD solid models into durable and functional plastic, metal, or ceramic parts and tools in a fraction of the time required by traditional machining and tooling processes. The Vanguard SLS system from DTM Corp. was designed to be an improvement over the company's Sinterstation system, which also uses a selective laser sintering process. "Today's manufacturers want the benefits of rapid prototyping such as speed, versatility, and minimized downstream labor and costs, but they also demand accuracy, repeatability, and the ability to move into rapid manufacturing," says vice president Patrick Lordi. "We have made the Vanguard SLS a practical rapid manufacturing system."

Based on benchmark comparison builds, the system offers an improvement of up to 20% in dimensional tolerance over the Sinterstation 2500. In another benchmark test, the Vanguard was able to complete the Sinterstation's 15-hour augur in less than 7 hours. The speed at which the CO2 laser transforms the powdered material into a solid and builds the part has also been enhanced. The new system is capable of delivering smoother surface finishes due to an improved scanning and beam-delivery system. In addition, parts can be created with 0.02–0.025-in. walls.

Users can nest, stack, and add parts during a build, and most parts require only 1 to 3 hours of attended operation before final finishing begins. "The culmination of these improvements means users will have the ability to produce more parts per hour directly from their CAD data," says vice president of marketing and business development Kevin McAlea. "The parts are created with less labor, and at less cost than ever before."

Milling and engraving machine equipped with functional software

Offered by Gold International Machinery Corp., the MDX-500 comes standard with a range of functional software.

A rapid prototyping and mold-making machine has a high-torque spindle that allows it to mill light metals including aluminum, brass, and copper. When the high-torque spindle is replaced with a high-speed spindle, the MDX-500 is capable of engraving 3-D names, logos, and images on a range of materials. Available from Gold International Machinery Corp., the machine comes standard with 3D Engrave, Modela Player, and Virtual Modela software.

3D Engrave adds thickness to a flat, two-dimensional graphic to create a 3-D form and allows the machine to model or engrave on curved surfaces. The Modela Player can produce 3-D models, relief signage, and prototypes; it accepts DXF or STL files created by commercial CAD/CAM packages, and outputs to the machine for heavy-duty design applications. Virtual Modela simulates the machining process by showing suitable modeling and engraving depth and time parameters before the job is sent to the system.

The MDX-500 supports industry standard NC codes and can link with standard 3-D and CAD/CAM software. The machine is equipped with an emergency stop switch and can be supplied with a safety cover that makes the cutting mechanism inaccessible during operation. The optional cover prevents swarf and dust from entering the surrounding environment, making it suitable for use in an office. Compatible materials include ABS, modeling wax, aluminum, brass, and other nonferrous metals.

Katherine Sweeny

Copyright ©2001 Medical Product Manufacturing News

Spotlight on Pressure Sensitives and Adhesives

Originally Published MPMN October 2001

Spotlight on Pressure Sensitives and Adhesives

Cold-temperature label material

A pressure-sensitive material is designed for labels exposed to extreme cold temperatures. The TLP 866 has comformability characteristics when applied to small-diameter surfaces that make it suitable for vial marking. A special top coating enables labels made of the material to be preprinted with static information and then imprinted with variable information such as bar codes and serial or lot numbers. Tailored Label Products Inc., W165 N5731 Ridgewood Dr., Menomonee Falls, WI 53051.


Skin contact adhesives

A company offers standard or custom designs of medical-grade skin contact adhesives and pressure-sensitive materials for applications in wound-care, ostomy, electromedical, surgical drape, and diagnostic markets. Materials available include films, foams, foils, adhesives, hydrocolloids, laminates, and woven and nonwoven fabrics. Avery Dennison Medical, 7100 Lindsay Dr., Mentor, OH 44060.


Double-coated adhesives

A double-coated tape is designed to provide flexibility and comfort to patients. The DC 500 tape is suitable for surgical drapes, medical device assembly, patient monitoring, and mounting medical devices to skin. It is a 3-mil, clear, low-density polyethylene film. The release liner is an 80-lb, bleached, supercalendered kraft, silicone treated on both sides for differential release properties. Tyco Adhesives, 1400 Providence Hwy., Norwood, MA 02062.


Electrically conductive adhesive tapes

Nonmetallic, highly conductive acrylic adhesive–based tapes are suitable for bonding the connector components of an electrode to a second substrate. The ARcare 8874 and 8881 tapes facilitate the transmission of signals sent through the adhesive to make the electrical connection. They can be used in a range of multifunctional electrodes including monitoring electrodes for retrieving cardiac, nerve activity, and muscle movement data; electrodes for the delivery of pain control and therapies; and disposable electrode pads found on automatic external defibrillators. Adhesives Research Inc., P. O. Box 100, Glen Rock, PA 17327.


Curing adhesive

A room-temperature curing adhesive can operate in temperatures up to 145°C. Tra-Bond FDA23 is electrically nonconductive, has excellent lap shear properties, and is semirigid, making it suitable for the repair and assembly of medical devices. Applications include endoscope repair and catheter assembly, bonding, and encapsulating. Tra-Con Inc., 45 Wiggins Ave., Bedford, MA 01730.


Hot-melt adhesive coating systems

Web coating and laminating lines are suitable for the application of hot-melt adhesives to produce products such as ECG patches, transdermal delivery systems, breathable laminates, adhesive films, tapes, and bandages. Several coating techniques are available to produce full-width coverage, down-web stripes, or customer-specified dots and patterns in web widths to 80 in. Substrates can include film, foam, paper, release liners, nonwovens, wovens, and hook and loop. May Coating Technologies, 1120 Red Fox Rd., St. Paul, MN 55112.


Metal-bonding adhesive

A methacrylate metal-bonding adhesive provides a combination of high strength, fatigue endurance, impact resistance, and toughness on metals and other substrates including stainless steel, aluminum, thermoplastics, and composites. The MA820 is a two-part adhesive that requires no primers and little or no surface preparation on most substrates. A low-odor nonsagging gel with good tolerance to off-ratio mixing, it has a working time of 4–6 minutes, achieves 75% of ultimate strength in 30–35 minutes, and cures with no surface tack. ITW Plexus, 30 Endicott St., Danvers, MA 01923.


Acrylic and latex-free adhesives

Pressure-sensitive adhesive-coated skin contact products offer a selection of acrylic and latex-free rubber-resin adhesives that can incorporate active ingredients such as antimicrobials. The products include Dublfilm double-sided tapes, Bioflex PVC and polyurethane foams, and UniFilm unsupported transfer adhesive films. Scapa Medical, 540 N. Oak St., Inglewood, CA 90302.

Copyright ©2001 Medical Product Manufacturing News

Developments in Device Connectivity

Originally Published MPMN October 2001

PRODUCT UPDATE

Developments in Device Connectivity

From right-angle interconnects for use in harsh environments to wireless solutions, these suppliers have the right connections

Reliable performance, flexibility, safety, and ease of use are among the primary concerns of device manufacturers sourcing connectors, according to suppliers. OEMs want assurances that "continuous performance will not be compromised, and that our products are sufficiently adaptable for custom applications and to mate with other manufacturers' products," says ODU-USA Inc. application engineer Ric Miller. Availability is also a key issue, he adds, noting that short delivery times are a point of pride at his firm.

Considering the end-use environment, safety is equally important, adds Deby Forster, creative services manager at Fischer Connectors. That was a prime consideration behind the development of the SureGrip housing on the company's medical-grade products.

Meanwhile, in the wireless world, an Internet-enabled implantable device developed by Medtronic is a clear indication that the above concerns can be adequately addressed by next-generation technology. This predicate device will spur the development of wireless healthcare products, according to Jerry Klintz, program director at Colorado MEDtech.

Whether you are sourcing connectors or other electronic components, the accompanying Buyers Guide grid starting on page 58 provides a comprehensive listing of suppliers complete with contact information and a description of their core products.

The right angle for harsh environments

Right-angle connectors from ODU-USA Inc. feature a housing and a locking mechanism that protect components from contaminants.

The Minisnap line of miniature connectors developed by ODU-USA Inc. features a push-pull locking mechanism that enables mating even in hard-to-reach places. The latching fingers hook into a groove inside the receptacle, making unintentional separation almost impossible. A right-angle connector for medical electronic equipment and instrumentation is one of the most recent additions to the product line.

Designed for use in harsh environments, the IP68 K-series connectors are "watertight and impervious to outside contaminants," stresses application engineer Ric Miller. "The housing and locking system of the Minisnap connectors protect the contacts from outside mechanical influence, impurities, dust, and unintended contact with and penetration of moisture, water, and other liquids."

Available in two sizes with 2- to 14-contact configurations, the connectors are designed to mate with most industry-standard products. To achieve this compatibility, "the K-Series housings have a larger diameter [than other models]," says Miller. To ensure that they remain watertight, cable grommets and seals are used, he adds. The plugs can also be potted to maintain watertight properties in unmated conditions.

The firm also recently introduced a size-4 connector that is designed for applications requiring a larger contact size or greater number of contacts. It is available with a plastic or metal housing and, like the K-series connectors, mates with most standard interconnects.

The K series comes with solder PCB pins, solder cup, or crimp contacts; the size-4 model has solder contacts.

Minisnap connectors have been tested for electromagnetic compatibility using the inductive wire (or parallel wire) method in accordance with procedure VG 55214-6-2. Documentation showing that the products achieve lower than –55 db attenuation is available. The connectors can be supplied in standard or autoclavable versions that withstand 1500 sterilization cycles.

Miller notes that ODU is currently focusing on expanding its line of plastic connectors. There is a growing demand for "lightweight, low-cost plastic connectors, and that has necessitated new housing designs, sizes, and contact configurations," he says.

Housings help users get a grip

Connectors from Fischer are fitted with a durable housing that can be securely gripped even by personnel wearing gloves.

Also striving to meet demand from the OEM marketplace for miniature plastic connectors, Fischer Connectors offers models with up to 19 gold-plated contacts. They incorporate a reliable push-pull positive-locking mechanism and offer a degree of protection equal to the IP68 standard. The impact-resistant plastic housing and plug body can be securely gripped, even if the user has wet hands or is wearing gloves.

The connectors are available in versions with 2 to 19 gold-plated contacts, and they feature a self-aligning keying system that was developed by Fischer in the early 1950s. "The Fischer keyway prevents the user from mating the two parts unless they are correctly aligned," explains creative services manager Deby Forster. Color-coding options are available, and the products have been tested to 5000 mating cycles.

"Medical device OEMs demand safety, quality, sterilizability, compliance to standards, and ease of use from their connectors," says Forster. In that respect, this series of connectors is suited for healthcare applications, she adds, because it "uses a durable plastic housing that withstands sterilization and an insulated construction that ensures safe operation for doctors, nurses, and patients," she says.

The wireless revolution

An implantable heart-monitoring device that Medtronic demonstrated at the North American Society of Pacing and Electrophysiology conference in Boston in May is great news for patients with a cardiac condition. The Chronicle, which is not yet on the market, will be able to transmit critical data to secure Internet sites. This will enable physicians to determine from a remote location whether the patient's heart has had an event, and the frequency and duration of those events. Being able to determine at a distance whether a face-to-face consultation is necessary adds a new measure of convenience and safety to implantable devices. For Jerry Klintz, program director at Colorado MEDtech, the Chronicle represents even more than that: it is a predicate device that will usher in an era of wireless healthcare products.

The company presented its vision of wireless connectivity at this year's MD&M exposition in New York City. In its booth, Colorado MEDtech installed a mockup of an intensive-care unit with a communications technology platform that monitored and controlled vital-signs units, IV pumps, and other devices. "We were demonstrating the capability not only of transmitting and receiving medical device data through a wireless connection," says Klintz, "but also the transmission of commands back to those devices." Klintz notes that there are still some security and safety issues that must be resolved before this technology can be made generally available, but, he adds, "we are on the verge of succeeding."

Colorado MEDtech demonstrated the potential of wireless connectivity in an ICU at MD&M East 2001.

Colorado MEDtech also displayed its Link It technology, which connects new and legacy devices to the World Wide Web to enable remote software upgrades and to provide access to clinical data. "It converts protocols from legacy instruments via an RS-232 connection into a packetized 802.EEE Ethernet. Then, we can add a wireless connection, if required, or put it straight on the Web," says Klintz. The company has developed custom versions of the product for use with existing instruments.

It is also currently developing the hardware and software for a plug-in diagnostic module for a handheld PDA-type device.

To spread the word on wireless connectivity, Colorado MEDtech is sponsoring a series of seminars on the topic. At the one-day sessions, industry experts will report on the state of wireless technology, analyze existing connectivity standards, and share connectivity solutions. Speakers will include Colorado MEDtech senior vice president of product development and technology Bill Wood and Ray Jones, who is responsible for software programs, including embedded-software development. The seminars are scheduled to be held in San Francisco on October 23, San Diego on October 25, and Anaheim, CA on October 26.

From external to embedded solutions

Device Server Technology developed by Lantronix Inc. enables OEMs to connect devices to the Internet or other networks using standard protocols. The company's most recent product is DSTni, a single chip that contains all of the essential hardware components that allow devices to be remotely monitored or controlled over the Internet or shared networks. The chip's 12 x 12-mm ball-grid-array footprint makes it suitable for integration into the smallest devices. DSTni is designed for device OEMs seeking advanced integration, says technical marketing manager Paul Wacker, but the company offers a range of other options that achieve similar outcomes.

A chip with a 12 x 12-mm footprint developed by Lantronix Inc. allows devices to be remotely monitored or controlled via the Internet.

"We have found that OEMs first dip their toe in the water by going with our external solution, which connects a serial port to an Ethernet box," says Wacker. "That automatically puts a legacy device on-line." The company also produces a smaller version that is designed in the box, he adds. "From there we drop it down to the semiconductor level, where you're integrating more silicon into the motherboard. That's the typical migration path for most OEMs," notes Wacker.

DSTni comes with a suite of on-chip peripheral hardware to minimize integration risk and a 96-MHz processor. In addition to two 10/100 Ethernet MACs and an integrated physical layer, the chip has four high-speed serial ports, CANBUS, SP1, I2C, and parallel I/O. To ease installation, the company offers an OEM developer's kit that contains a reference design board and network-enabling software. Also included are a TCP/IP protocol stack to facilitate Ethernet connectivity, a set of C libraries and sample source code, and a Web server that enables standards-based graphical presentation, access, and control via any Web browser.

Norbert Sparrow

Copyright ©2001 Medical Product Manufacturing News

Miniature Micrometer Head Aligns Optical Components

Originally Published MPMN October 2001

HOTLINE

Miniature Micrometer Head Aligns Optical Components

Unit requires little space or operating force

A compact micrometer head from Del-Tron Precision Inc. offers both coarse and fine adjustment capabilities.

A differential miniature micrometer head from Del-Tron Precision Inc. (Birmingham, MI) is suited for precision laboratory instruments and other optical devices. The DF-1 ultrafine head aligns components while minimizing space and operating-force requirements. The small unit measures 0.450 in. diam and is 1.656 in. long. "Most other comparable devices are two to three times that long," says the company's vice president of marketing Ed Keane. In addition to its compact size, the device offers a range of adjustment capabilities. Total coarse movements span 0.25 in. with reductions of 254:1 or 508:1. Maximum fine adjustments range from 0.020 to 0.040 in.

The DF-1 head mounts to linear slides, stages, or the company's 99-series subminiature multiaxis positioners using a finely threaded barrel. Coarse adjustment is performed via a knurled ring that moves the spindle 0.025 in. per revolution. A thimble at the rear of the device performs fine adjustment of 0.002–0.004 in. per revolution. A hardened spindle ball reduces friction and wear.

Zachary Turke

Del-Tron Precision Inc., 5 Trowbridge Dr., Bethel, CT 06801; Phone: 203/778-2727; Fax: 203/778-2721


Downstream Unit Boosts Film and Sheet Throughput

System is suited for production of medical films and transdermal drug-delivery devices

When equipped with the new film and sheet downstream unit, the ZSE-27 twin-screw extruder from Leistritz can accommodate higher throughput rates.

Available for use with any high-speed single- or twin-screw extruder, a film and sheet downstream system facilitates compounding, devolatizing, and reactive extruding. Offered by Leistritz (Sumerville, NJ), the system is designed for use with the company's ZSE-27 twin-screw extruder, and produces 5–125-mil-thick samples up to 12-in. wide. Typical end products include medical films and transdermal drug-delivery devices. The three-roll stack uses 8-in. diameter x 14-in. spiral baffled mirror-finish rolls with rotary unions for liquid cooling or heating. A 3-hp ac flux vector motor drive enables a 1000:1 turndown ratio. Air cylinders provide 500 pli. The upgraded roll-stack design accommodates the high throughput rates associated with the new 1200-rpm version of the ZSE-27. Options include a gear pump front-end attachment, edge trim devices, payoff stations for lamination, a winder or guillotine, and coextrusion packages. "The unit is ideal for medical film and sheet development, narrow-width production, and transdermal applications," says general manager Charlie Martin.

"It integrates the features of larger production systems into a small-scale system."

Katherine Sweeny

Leistritz, 169 Meister Ave., Somerville, NJ 08876; Phone: 908/685-2333; Fax: 908/685-0247


Software Provides Paperless Quality Data System

Read-only version allows access to reports and operator instructions

OPACT 2001 from Integral Solutions Inc. provides users with read-only access to operation instructions and quality control plans.

Quality control and engineering software is designed to allow users to view operator instructions by means of a touch screen or industrial PC within the manufacturing environment. Offered by Integral Solutions Inc. (Royal Oak, MI), Operator Planning and Control Tool (OPACT) 2001 is a view-only version of the company's MPACT 2001 advanced quality-planning software. OPACT shares the MPACT database to ensure the latest controls are being followed via updated control plans. On-line operator instructions can include visual aids to illustrate manufacturing process steps. The new version also incorporates e-mail operations to facilitate communication between operators, manufacturing supervisors, and engineers via MAPI-compliant e-mail software such as Microsoft Outlook, Eudora, and Lotus Notes.

According to company president Dane Barranger, "OPACT can supply timely, easy-to-access quality data right where the operators are located. There's no need for manufacturers to deal with hard-copy documentation that must be constantly updated."

OPACT also takes advantage of some of MPACT's enhancements such as Web reporting, which allows users to share reports and documents with customers or partners over the Internet or through their company's internal site. Medical device manufacturing support includes labels and terminology for drug hardware and disposables, as well as First Article and First of Code support.

Katherine Sweeny

Integral Solutions Inc., 222 E. Fourth St., Royal Oak, MI 48067-2607; Phone: 248/543-6040; Fax: 248/543-2882; Internet: www.integralsolutions.com

Copyright ©2001 Medical Product Manufacturing News

Long-Fiber Compound Reduces Nebulizer Costs

Originally Published MPMN October 2001

PROFILE

Long-Fiber Compound Reduces Nebulizer Costs

Molded compressor components provide repeatable, long-term creep resistance

Manufacturers of nebulizers, which are used by people suffering from asthma and other bronchial ailments, are seeking ways to reduce production costs for their devices. Increased competition coupled with changes in healthcare coverage are two of the factors driving this trend.

Thomas Industries' nebulizer relies on RTP's long-fiber compound for its motor-end bracket and housing.

One method Thomas Industries (Sheboygan, WI) used to reduce its production costs was to replace compounds used to mold two compressor components on its devices. The company's nebulizers are fitted with compressors in which injection-molded components are assembled by means of an efficient snap-fit method. After evaluating several other materials in terms of cost-effectiveness, Thomas turned to RTP Co. (Winona, MN) for a long-fiber compound for the two components—the motor-end bracket and the housing.

The compound the two companies developed provides the repeatable, long-term creep resistance that is critical to facilitating the assembly process, thus reducing costs.

"Initially, we tried long-fiber PET but did not obtain the required material or part properties," says Thomas Industries' senior key project leader Roy Rozek. "We then considered long-fiber nylon, but were very concerned that the dimensional stability could present a problem due to moisture absorption."

RTP's engineers provided a material that consistently processes to fixed dimensions. According to Rozek, changes of less than 0.001 in. occurred on critical dimensions during mold capability studies of a 4-in. part. This included comparing dry-as-molded parts with full moisture-saturated components.

The RTP 200–series nylon specialty compound is reinforced with long glass fiber to provide flexural strength. Unnotched Izod impact strength is 24 ft·lb/in. at 1/8 in., and flexural strength is 50,000 psi. The material is heat stabilized and carries a UL 94 HB flame-retardant rating.

Even after processing, the long-fiber compound from RTP Co. resists thermal and stress pressures.

The motor-end bracket is designed with extended fingers that retain a sintered bronze self-aligning sleeve bearing in a snap-fit pocket. The molded fingers were studied using finite element analysis to ensure that the design could maintain long-term spring retention and to prevent bearing rotation. At the same time, the material was subjected to lab testing to verify the long-term creep-resistance properties of the resin.

The housing features an insert-molded standard ball bearing and flexing cantilever supports. The supports, which were analyzed in the same way as the fingers, also withstand bending stress as the compressor head is snapped onto two upright parts.

Compressor parts, in their final assembled, or stressed, positions, survived thermal aging testing for 3 hours at 225°F. These tests simulate 8 to 10 years of aging at normal room temperature. According to RTP, the tests showed no noticeable flexural change in the cantilever beams and no movement or loosening of the bearings.

Copyright ©2001 Medical Product Manufacturing News

September 11, 2001

Originally Published MPMN October 2001

EDITOR'S PAGE

September 11, 2001

I was going to write about the ongoing efforts of national and international medical device associations to promote patient access to life-saving medical technologies. That topic tied in neatly with one of the main themes of the Global Medical Devices Conference scheduled to take place in Barcelona, Spain, next month. I've tried to structure my thoughts on this issue, in vain. Today my mind is on the death and destruction that engulfed New York City, Washington, DC, and western Pennsylvania.

I've seen the horrendous footage of the Boeing 767 slicing into the South Tower of the World Trade Center dozens of times. Repeated viewing of a tragic event is supposed to have a desensitizing effect. Not this time. The same numb feeling of dread grips me each time I see the tape. It is one of many indelible images that will haunt me and all of us for the rest of our lives.

By the time you read this, the inchoate shock will have subsided, replaced by rage. We will have a more precise idea of the number of casualties. We will probably know with some certainty who performed these evil acts and who may have orchestrated them. We may even have launched retaliatory actions. At the time of writing, much of this is still within the realm of speculation. I am sure of one thing, however: our nation will never be quite the same.

A small group of fanatics did more than destroy innocent lives on Tuesday, September 11— they raped our collective psyche. They revealed to us our vulnerability, and left us feeling violated.

Our daily lives will begin to resemble those of many cities around the world that have been targeted by terrorist groups in the past. Cadres of armed personnel will patrol airports and other public places. Security measures will be pervasive. An unattended car or a parcel will be a bomb in waiting until proven otherwise. Some of us will begin to question if racial and ethnic profiling is really such a bad idea, after all. Civil rights will become conditional. And the terrorists will have won another victory: They will have robbed us of some of our freedom, some of our soul, much of our innocence. I find that sad beyond words.

To those of you who may have experienced a loss in this terrible tragedy, I would like to take this opportunity to extend the heartfelt condolences of the MPMN staff and Canon Communications. Our thoughts and prayers are with you and your loved ones.

Norbert Sparrow

Copyright ©2001 Medical Product Manufacturing News

Lipid-Resistant Resin

Polycarbonate resin used in infusion pumps. A lipid-resistant polycarbonate resin manufactured by Bayer Corp. (Pittsburg, PA; 412/777-2000) provides the material for the Discofix line of three-way stopcocks and manifolds produced by B. Braun Medical (Bethlehem, PA; 877/428-7766) for infusion systems. The Makrolon Rx-1805 polycarbonate displays stress-crack resistance when it makes contact with lipid emulsions. The dimensional stability of the resin also ensures that tube connections remain permanently secure. B. Braun's three-way stopcocks are supplied in an individual pack sterilized with gamma rays or EtO. The transparency of the polycarbonate facilitates fast, accurate visual monitoring of the infusion procedure in the clinical setting. Makrolon Rx-1805 complies with ISO 10993-1 for biocompatibility of plastics used in contact with human tissue for 30 days or fewer.

Press slide granulators designed for extrusion and blow molding.

A line of press slide granulators is custom designed for a variety of extrusion and blow-molding processes. Hosokawa Polymer Systems (Berlin, CT; 860/828-0541) offers a complete set of options for configuring its press slide granulators for use in extrusion and blow-molding processes. The machines are useful in a number of different plastics regrind applications, including extruded profiles, thick and thin sheet, film, and blow-molded bottles. The granulators' options include side-feed chutes for accepting extruded profiles, front-mounted sheet-feed hoppers, roll-feed assemblies for thick sheet and film, venturi systems for sending rejected blow-molded bottles into the granulator, and evacuation systems with blower/cyclone units for continuous volume applications. The four standard granulator sizes offered range from the Model 68, which has a 6 x 8-in. throat size at chamber entrance and a 250 lb/hr throughput, to the Model 1120, which features an 11 x 20-in. throat size and a 460 lb/hr throughput. The granulators stand upright for versatility and convenience. All come standard with a triple-ply laminate for quiet performance. Soundproofed models are available; they reduce noise levels to below 80 dbA.