Medical Device Link.

Originally Published EMDM May/June 2005

Regional Focus

A central location and a knowledge-driven high-tech manufacturing environment maintain the region’s competitive edge.

Norbert Sparrow

The year was 1922, and it was the beginning of a beautiful friendship. The Kingdom of Belgium and the Grand Duchy of Luxembourg had just established a customs union. The union was dissolved in 1940, but reestablished after World War II on May 1, 1945. The Netherlands joined in 1947, creating the Benelux Economic Union.

The agreement set an example for other European countries. At the Messina Conference in 1955, the foreign ministers of Belgium, France, Germany, Italy, Luxembourg, and the Netherlands adopted the objectives of the Benelux programme. The Messina Resolution, in no small measure, pointed the way to the single market.

While Belgium, the Netherlands, and Luxembourg played a considerable role in the construction of Europe, they have not been major players in Europe’s medical technology industry. The three countries combined represent approximately 6% of Europe’s med-tech market, according to statistics from EUCOMED. Of that total, the Netherlands accounts for 4.6%. Which raises the question: why devote a Regional Focus to Benelux in EMDM? The answer is quite simple: Benelux represents a disproportionately large share of suppliers to the medical device industry. More than 12% of the companies in our suppliers database—the source list for our annual Buyers Guide—are located in Belgium and the Netherlands. There’s a simple three-word explanation for this disparity, says Ron Peacock, marketing manager at Sterigenics (Verviers, Belgium): “distribution, distribution, distribution.”

Over the years, says Peacock, “the perception of this area as a central distribution centre for the whole European market has increased dramatically. It’s an excellent location for distributors, both in terms of geography and population density,” he says. “You are rarely more than three to four hours from Europe’s major cities.”

Distribution was also a central concern for Microtek, a firm that manufactures medical disposables on a contract basis for global customers. Its European headquarters is located in Newcastle-under-Lyme, Staffs, UK, but it recently acquired two facilities in the Netherlands to establish a physical presence on the continent.

“About 45% of our business involves global OEMs,” says marketing manager Harry te Winkel. Because Microtek works with offshore suppliers, easy access to a distribution point was a key logistical concern. “We needed a world-class port,” says te Winkel, “and Rotterdam’s port is second only to Shanghai’s.” The Dutch connection works well for the company. “Our European customers expect personal interactions,” explains Paul Baaker, Microtek’s director of international OEM activities. “But they also want low prices.” By offshoring some of the production and maintaining a strong presence in the centre of Europe—including a production facility with a cleanroom in Zutphen—“we can offer our customers the best of both worlds,” says Baaker.

Several suppliers we spoke with stressed the importance of the region’s knowledge base. “A high-tech environment has taken shape in Belgium and the Netherlands,” says Ineke Verweire of Corpura, a firm that produces polyurethane foams. “Labour costs are high, so inevitably production is based on knowledge rather than handling,” she adds. The presence of EU institutions and NATO have contributed to making the Benelux countries a sort of “intellectual centre,” she adds.

Stronger than steel, a polyethylene fibre developed by DSM Dyneema is used in orthoaedic sutures and surgical implants.

Verweire, like many of her colleagues, is resigned to the fact that Western European countries can’t compete with China and other low-wage countries when it comes to product assembly and the manufacture of commodity products. Emphasis on R&D and the development of novel technologies will maintain the area’s industrial edge. DSM Dyneema (Heerlen, Netherlands), which has built a new production line for the fabrication of medical-grade fibre, shows how it’s done.
Dyneema Purity is the world’s strongest fibre, according to the firm. The polyethylene fibre is 15¥ stronger than steel and, weight for weight, 40% stronger than competing aramid products. Its properties include resistance to moisture, abrasion, UV rays, and chemicals. In addition to its use in bulletproof armour and ropes and cables in the shipping industry, the fibre is popular with medical device OEMs for the fabrication of orthopaedic sutures and surgical implants.

Dyneema Purity was introduced at the meeting of the American Academy of Orthopaedic Surgeons in San Francisco, CA, USA, in March 2004. It was an immediate hit. Attendees were impressed by its combination of strength and fatigue resistance, which reduces the risk of fracture during and after an operation. Yet, the material also has a nonabrasive silk-like feel. This combination of properties provides design engineers with an opportunity to rethink device designs on a smaller scale, says the company. The material has several potential applications in minimally invasive devices.

“There was strong demand for the fibre from the device industry,” says Christophe Dardel, director of DSM Dyneema, “especially in the United States.” The new production line at the company’s Heerlen site will allow the brand to be launched in other markets, says Dardel, who adds that “we will see it being used in many other biomedical applications currently under development.”

DSM Dyneema has a unique product, but it is not a unique company. In the following pages, nearly two dozen regional firms are profiled, all of which combine expertise in their chosen field with a commitment to serving the needs of the device industry.

Additional reporting by Caitlin Cook

Technoplast B.V.

A contract moulding firm with more than 50 years of experience takespride in the range of services it provides to medical device OEMs. Technoplast B.V. (Tilburg, Netherlands) can call on teams of design engineers, product development specialists, and injection moulding experts and toolmakers to translate complex project requirements into finished devices. Typical projects include IVD test housings and syringe parts as well as fully assembled products.

A Class 10,000 cleanroom is on-site, and the firm has 31 moulding machines in tonnages ranging from 25 to 275 t. A fully integrated quality control system—with appropriate certifications—and strict adherence to project management principles ensure that the quality requirements of medical device OEMs are met in a timely manner.

Europlasma N.V.

The medical device industry currently accounts for approximately one-third of Europlasma’s business, but that is a fairly recent development. “In the early days, Europlasma (Oudenaarde, Belgium) was focused exclusively on the PCB market,” recounts sales and marketing manager Paul Lippens. “We had been getting requests for custom machines from the medical device and other industries, though, and in 1993 Europlasma began building machines for diverse applications.” Medical technology quickly became a core activity.

Gas-plasma technology is a dry and environmentally sound method to prepare and modify polymers, notes Lippens. Its primary uses in the medical arena include the activation of catheter hubs and extension lines prior to printing and preparing balloon catheters, connectors, and syringe hubs to facilitate bonding. The activation process also promotes cell growth on microtitre plates. “Another application of the technology,” adds Lippens, “is the fine cleaning of stents, dental implants, and guidewires prior to sterilization.” In addition, the technology can be used to render permanent hydrophilic coatings on nonwoven PP and PET, intraocular lens applicators, and inhalation devices. Hydrophobic coatings on intraocular lenses and barrier coatings on packaging can also be obtained.

“Equipment to treat catheters is a big part of our business,” says Lippens, who adds that the company draws on a well of expertise to maintain innovation. One of its most recent developments involves the treatment of thick foams to promote hydrophilic and hydrophobic properties. “It was originally developed for avionics, but we think it may also have medical applications,” says Lippens.

The foam is treated under vacuum conditions in the 10-2–10-3-mbar pressure range. Gas is introduced into the chamber, where it is ionized by means of a high-frequency generator. The plasma particles react with the surface of the substrate, imparting hydrophobicity without altering the foam’s structural properties. The material’s open cellular structure enables the plasma-polymerized coating to penetrate the entire bulk of the material, a process for which Europlasma has a patent pending. Foam plates as thick as 120 mm can be successfully treated in this manner.

In other news, the firm recently partnered with Fung Yu Electrical and Machinery Co. (Hong Kong), which will integrate and resell Europlasma’s vacuum plasma equipment throughout China. The initial focus will be on the treatment of nonmedical plastic parts, says Lippens, “but we see great potential in the medical market over there.”

Medisize

Two decades ago, Medisize (Hillegom, Netherlands) carved out a niche making custom IV sets for Dutch hospitals and practitioners. It achieved another milestone in 1995 when the firm introduced its own line of respiratory products, which were sold under the Medisize name. “This was a real turnaround for the company,” says managing director Willem van den Bruinhorst. “We automated as much as we could to market the line worldwide.” Around the same time, the facility inherited some moulding machines from a UK plant that Medisize had acquired. The resulting overcapacity led to an opportunity. “That’s how our subcontracting business began,” explains van den Bruinhorst. Today, the company provides outsourcing services from plants in Ireland and the Czech Republic, as well as the Netherlands. At the end of 2004, it acquired Switzerland-based Createchnik.

Despite its far-flung operations, there is a singular purpose at the heart of Medisize’s strategy, stresses van den Bruinhorst: “We are first and foremost a medical company. We only manufacture medical products—for ourselves and for other companies. That creates a mindset among our employees,” he says. “They know what it takes to manufacture to medical standards, to validate, sterilize, and put the CE mark on something.”

“We are not simply a moulding company,” says van den Bruinhorst. “We provide product development, moulding, assembly, validation, and packaging services. And we only do medical.” In addition, the company is constantly adding to its arsenal of skills. “We want to maintain control over the key technologies,” explains van den Bruinhorst. When customers began talking about liquid-injection moulding, Medisize brought the capability in-house. “In Ireland, when we acquired Donegal Healthcare, we added non-PVC film welding to our services,” says van den Bruinhorst. It all boils down to a company that, in his estimation, is driven to
be “process intensive, capital intensive, and know-how intensive.”

TeMePro B.V.

A company with expertise in the production of bare or PTFE-coated stainless-steel, precious metal, and special-alloy wire recently joined forces with a mechatronics-oriented engineering firm. The partnership produced a unique one-stop shop, according to TeMePro B.V. (Oldenzaal, Netherlands).

Offering coiled and formed components for a range of medical applications, TeMePro produces wires in diameters as small as 0.03 mm and in coil lengths up to 6000 mm. Its new partner, the Demcon Group, was originally a spin-off company from the University of Twente. With more than 50 engineers on staff, Demcon offers project management, consulting services, engineering, prototyping, and production capabilities related to mechatronics.
The Demcon Group also includes MIMO Technology B.V., which offers metal-injection moulding of small and complex parts, and Micro Montage B.V., which assembles hearing aids, microvalves, and other small products on a contract basis.

This confluence of expertise, says TeMePro managing director André J. Boskemper, provides customers with a unique opportunity to source a range of problem-solving, technical support, and product development and production assistance in one location.

Vreeberg

Elastic materials are extruded in film or sheet form for medical applications by a company that has several years of experience processing rubber and thermoplastic elastomers (TPEs). The base polymers used by Vreeberg (Vreeland, Netherlands) comply with the European Pharmacopoeia and US FDA guidelines, while the monomers meet the requirements of directive 90/128/EEC. In addition, styrenic resins processed by the firm meet USP Class VI requirements.

TPE-based products manufactured by the firm are used to make operating room covers and drapes, and blood-bag parts. The firm’s cutting and slitting capabilities enable it to meet any number of specific customer requirements.

An on-site laboratory enables the firm to assist customers in product development. It has provided consulting and technical support on a number of projects involving the use of elastic materials.

Colpitt B.V.

A radio transmitter abandoned by a US soldier after World War II ultimately led to a revolution in medical bag welding. The transmitter was found by a Dutch blacksmith who liked to tinker with radios. His tinkering ultimately led to the fabrication of a radio-frequency (RF) welder that he used to join PVC. The technique was initially used to process consumer products, but in 1960 it came to the attention of the Dutch Red Cross, which began using RF welding to produce flexible blood bags. The rest, as they say, is history. Colpitt B.V. (Zandvoort, Netherlands) now makes a wide range of equipment that automates the production of flexible IV, blood, CAPD, parenteral, and other bags. While it is proud of its past, the company has its sights set firmly on the future. “We are always looking at the bigger picture,” says company president Henk Bakker. In that framework, automation looms large, he adds. “There is always something else to automate. That is where we are focusing much of our attention.”

Colpitt has invested considerable resources integrating automated processes into its welding equipment through the use of robots, feeders, and other systems. One of the company’s most recent developments is the integration of leak testers, which will allow 100% testing of bags during the production cycle. “It’s a project we are involved in with Gambro,” says Bakker. The research is geared to projecting how blood bag systems might look 20 years from now, he explains, adding that Colpitt is delighted to be a part of it. One of the objectives, says Bakker, “is to boost seal quality and continue to improve process control and validation.”

Colpitt is also building more turnkey systems for customers. It was recently involved in the design of a plant encompassing form-fill-seal, packaging, and sterilization processes. “We have established a significant knowledge base within our company,” says Bakker. “It’s a shame not to use that resource to its full capacity. Moving forward, we are looking at building more integrated systems.”

Luxilon Industries N.V.

Monofilament sutures manufactured from polyamide, polypropylene, polyether, and other materials are available in natural, phatolocyanine blue, and other colours to suit customer specifications. Luxilon Industries N.V. (Antwerp, Belgium) markets the monofilaments under the Sterilux name worldwide.

Polyamide sutures are characterized by their smooth, supple properties. A butyl and PET copolymer yields a soft and flexible material that is highly elastic; its mechanical properties translate well into knot strength. In addition to the basic polypropylene monofilaments, PVDF-based sutures were recently made available. They feature high lubricity.

The company places emphasis on its R&D capabilities and quality systems. Certified to ISO 9001:2000, the firm uses statistical process control and guarantees that the diameters of its products conform with the European Pharmacopoeia.

ATMI Packaging

Designed for the biopharmaceutical industry, a product that both stores and mixes various active ingredients reportedly results in reduced processing costs, increased throughput, and decreased risk of cross- contamination. The Newmix line from ATMI Packaging (Hoegaarden, Belgium) integrates the mixing and storage of critical ingredients by means of a noninvasive, closed-end design. The product has been engineered to meet rigorous biopharmaceutical standards. Newmix technology has the capability to accommodate a range of parameters, including varying temperatures and volumes, as well as liquid-to-liquid, liquid-to-powder, and powder-to-powder processes using different bag shapes, quantities, and mixing mechanisms. The company currently offers two equipment models.

The X-Mix system is designed for volumes up to 10 L/kg. Homogeneity is obtained by rotating a single-use hourglass-shaped bag around its centre point. This results in optimized mixing of powder-to-powder and liquid-to-powder ingredients. The C-Mix device is suited for larger volumes up to 200 L. A stainless-steel container within a single-use drum-shaped bag incorporates an enclosed and isolated stir-rod and impeller. This design enables users to homogeneously mix high percentages of powder into liquid.

Famos B.V.

A supplier of sterilization-related equipment and products offers precleaning and heat-sealing equipment, stainless-steel trays, transport systems, sterilization indicators, and a host of other products. Headquartered in Venlo, Netherlands, Famos B.V. also has a subsidiary in nearby Straelen, Germany, where sterility assurance indicators are manufactured.

Chemical indicators are produced at the German facility; it also distributes a range of biological indicators manufactured by a third party. A change in colour on the chemical indicators confirms that all of the necessary sterilization parameters have been met, explains department director Peter den Uil. “Biological indicators are the ultimate proof that the microbes have been killed, but you have to wait for the result. Chemical indicators react immediately.”

What gets much of den Uil’s attention these days, however, are the evolving standards on sterilization assurance and educating customers on the finer points of compliance. “There are four EN classifications and six ISO classifications relative to chemical indicators. That can get quite confusing for our customers,” says den Uil. The convergence of ISO and EN standards is en route, he notes, and that is to be applauded. “But some inevitable dissonance erupts on the road to harmonization,” he adds. “Manufacturers must test in accordance with the standards, and in some cases they have to redo the tests. It’s hard work, but there’s no way around it.” With his and Famos’s help, he hopes to be able to make achieving compliance a little bit easier.

Sentron Europe B.V.

ISFET sensors that are integrated into unbreakable glass-free pH meters and electrodes are a core product at Sentron Europe B.V. (Roden, Netherlands). Earlier this year, the firm introduced miniature electrodes that offer the same reliability and rapid response rates as the larger models it has been producing for the past 20 years.

Made of PEEK, the new microelectrodes measure 3 mm diam. The sensing unit is built into the conical end of the electrodes, making the devices suitable for measuring small volumes in microtitre plates, for example. Fully flexible or stainless-steel electrodes are available in similar dimensions.

The electrodes can be integrated into flexible pipes and can be linked with one of the four models of pH meters that the company manufactures. Key industries targeted by the firm for this product include the biotechnology and pharmaceutical sectors.

Vitalo

Thermoforming services are provided to the medical sector by a company that also offers in-house design, prototyping, toolmaking, and production in a Class 7 cleanroom. Packaging is routinely produced for catheters, pacemakers, implantables, pharmaceutical handling trays, hospital kits, and related devices. But what sets Vitalo (Meulebeke, Belgium) truly apart, according to general manager Ronny Debaere, is its focus on its customers.

Proximity to clients is a key consideration in the company’s strategy, notes Debaere. “Vitalo is a global company, and we need to be close to our customers. So, in addition to our headquarters in Belgium, we have factories and field offices throughout Asia and a partnership with a company in Boston to serve North America,” he says. This global network allows the company to offer convenient design support in many parts of the world, and then manufacture the product where it makes the most sense.

Being alert to customer needs sometimes means surpassing expectations, adds Debaere. “We invested a great deal of money in a state-of-the-art Class 7 cleanroom specifically for our medical customers,” he recounts. “It’s not unlike what you might see in a semiconductor fab: the material is brought in through a slot in the wall and is processed and sealed before it leaves the production floor,” says Debaere. It’s more sophisticated than what the healthcare industry demands, he adds, “but it really makes us stand out in terms of particulate-free production processes.”

Fortimedix

Those tiny stents that prop open arteries are a big deal at Fortimedix (Nuth, Netherlands). The firm has been involved in full-service contract stent processing for more than five years. During that time, the company has been in a perpetual race to increase production capacity to meet customer demand, says sales and marketing manager Henk Meens. “We produced 25,000 pieces in our first year; we are currently fabricating 150,000 pieces per year. Our production capacity by the end of 2005 will be 300,000 pieces annually,” says Meens. To maintain its competitive edge and continue this growth pattern, Fortimedix has prioritized automation of 100% inspection at its facilities.

“Stent prices will be coming down in the years ahead,” notes Meens. That makes automation a key to survival, he adds. The firm’s laser cutters run 24 hours per day, and engineers are currently working on automating electropolishing.

“Nothing is subcontracted out,” stresses Meens. “We can process all known materials, including titanium, and can manage products from development to market. That includes mounting them on balloon catheters and obtaining the CE mark.” The goal, says Meens, is to provide OEMs with a cost-effective one-stop shop where quality is a given. Or, as Meens tersely puts it: “Tubing comes in, and the stent goes out.”

The company, which added a second production facility in March, plans to increase its range of services yet again by offering crimping, packaging, sterilization, and other medical device assembly operations. In 2007, development and manufacturing will be under one roof in a new 3000-m2 facility.

“OEMs put all of their resources into coating technologies these days,” says Meens. “That does not leave them many opportunities to investigate new applications, which is where we come in. We can research special alloys, new base materials, and so forth. In the long term, we want to expand the stent technology platform . . . and develop new designs for new applications,” Meens adds.

Rogers Corp.

Foams for external use in such medical appliances and devices as splints, patches, and electrode pads have been specially formulated by a materials manufacturer from its urethane, silicone, and polyolefin products so as to meet internationally recognized ratings for body-contacting device surfaces. The product family consists of Poron Medical Urethanes, Bisco Medical Silicones, and Rogers Medical Polyolefins, all of which are biocompatible, fungus-resistant, and free of PVC, latex, and solvents. Rogers Corp., headquartered in Connecticut in the United States, recently began producing these medical-grade materials at its plant in Gent, Belgium. It showcased its capabilities to medical device OEMs at the recent MEDTEC event in Stuttgart, Germany.

“The range of products offers OEMs a number of options in terms of stiffness, conformability, and other properties,” notes area sales manager Paul Gower.
The open-celled, medium-density urethane foams are flexible, resist collapse, and are highly shock-absorbent; they come in thicknesses of 1.5–12.7 mm. Available in both open- and closed-cell structures and in thicknesses of 0.5–12 mm, the silicone foams maintain their dimensional stability after exposure to most sterilization processes. Lightweight, adhesive-friendly polyolefin foams 1.0- to 12-mm thick are easy to contour to fit any shape.

Clippard Europe S.A.

Proportional valves suited for use with ventilators, anaesthesia equipment, and noninvasive blood-pressure monitors feature a simple design, low power consumption, rapid operation, and robust performance. The EPV valves are based on the EV line of miniature pneumatic products from Clippard Europe S.A. (Louvain-la-Neuve, Belgium).

A proprietary valve design ensures that the armature is positioned in such a way that the variable output flow can be precisely controlled. This architecture provides engineers with a product malleable enough to overcome extreme system design challenges.

Instrumek B.V.

Implants and medical devices are produced by a contract manufacturer with extensive experience in precision machining for medical technology OEMs. Instrumek B.V. (Schiedam, Netherlands) processes a range of materials including stainless steel, titanium, fibre-reinforced polymers, and nitinol. In addition to turning, milling, and electrical-discharge machining services, the company offers numerous finishing operations in-house. Electrolytic polishing, passivation, welding, bead blasting, laser engraving, titanium colouring, lapping, and assembly can be performed according to precise customer specifications.

Certified to ISO 9001:2000, the firm’s quality systems ensure traceability and are set up to provide lot number engraving and material conformity certification.

Microtek Medical Europe Ltd.

A company focused on fluid and infection control products for surgical and hospital use manufactures medical disposables on a contract basis. Microtek Medical Europe Ltd. (Newcastle-under-Lyne, Staffs, UK) supplies an array of patient, equipment, and surgical film drapes; fluid collection and solidification products; and wound drainage devices, among other items. The firm recently acquired facilities at Varsseveld and Zutphen, in the Netherlands, with the stated objective of centering more of its business in Europe, according to marketing manager Harry te Winkel.

The Varsseveld facility will be largely devoted to the production of latex and nonlatex materials, says te Winkel. “We see those as being extremely attractive niche products for the medical industry,” he explains. The firm also operates numerous facilities in North America and in the Dominican Republic, and it is partnered with a company in China.

Manufacturing processes adhere to GMP guidelines, and the company’s quality systems are certified to ISO 9002.

GCC Europe B.V.

Laser marking systems are available for processing metal and nonmetal products. Developed by GCC Europe B.V. (Capelle aan Ijsel, Netherlands), the LaserPro Stellar Mark I-Series is designed for high-quality metal marking at speeds up to 300 characters per second, while the LaserPro Stellar Mark C-Series laser is suited for nonmetal products such as packaging or pharmaceutical products. The company is a relative newcomer to the medical manufacturing arena, says manager Bill Jen, but it feels that it has a product that the medical technology industry will find appealing.

“The LaserPro Stellar Mark-I series is a diode-pumped Q-switched laser that offers exceptional printing speeds but, most of all, is extremely precise,” explains Jen. “It is precise enough to mark 0.1-mm-high characters. It is well suited for marking minimally invasive surgical instruments that require a bar code, for example,” he adds.

Laser marking offers greater flexibility and can be more affordable than etching, notes Jen. The company’s systems can be integrated on production lines, but their flexibility makes them attractive to companies that produce prototypes and small batches of products. “Firms that aren’t making millions of units need something that is easy to operate yet achieves a certain quality level,” he explains. The user-friendly software that drives the two LaserPro Stellar Mark series of laser markers, says Jen, makes it easy for novice operators to produce high-quality bar codes, characters, and graphics.

Corpura

Polyurethane foams with antimicrobial properties are designed and manufactured for the medical, cosmetic, and personal-care markets by a recently established firm. Corpura, a subsidiary of Recticel (Wetteren, Belgium), has been operating in Etten-Leur, Netherlands, for about a year.

Its line of hydrophilic foams can absorb and retain up to 20¥ their weight in water. Moreover, they have a very fine cell structure and desirable tactile qualities. Vivo products are designed to be in contact with open wounds and body fluids. The pliable materials are lint-free and nontacky, and provide a cushioning effect. They absorb the wound exudate while maintaining a moist environment. Vivo foams withstand EtO and gamma sterilization and meet the biocompatibility requirements of ISO 10993.

“Our medical customers primarily manufacture wound-care products, but we also do some business in the colostomy and filter sectors,” says product manager Ineke Verweire. “We produce the foam rolls and can cut them to the desired thickness and width.” OEMs have taken an interest in the company’s ability to embed active ingredients in the materials, she adds.

“We have some antibacterial materials that incorporate a nanoengineered silver surface developed by a German company,” says Verweire. “And a recent development involves a polyurethane foam that is inherently antibacterial because of the covalent bond that is formed between the quaternary ammonium salt and polymeric structure. The material effectively traps and kills bacteria.”

Sterigenics

Contract gamma, EtO, and E-beam sterilization is provided to medical device OEMs by a firm with a global presence. Headquartered in Verviers, Belgium, Sterigenics has 38 plants throughout North America, Europe, and the Asia/Pacific region. It is currently building an E-beam centre in Shanghai, China.

The CompactCell gamma radiation unit and increasing use of parametric release on the EtO side are among the more recent developments at the company, according to marketing manager Ron Peacock. “CompactCell is a very small irradiator that can precisely process materials of any density,” he says. Achieving delivered-dose accuracy within 10%, the unit is suited for processing small volumes, quarterly auditing procedures, validation, and related tasks.

For customers using EtO sterilization, the firm offers a parametric release option in lieu of biological indicators. The technique enables confirmation of product sterility by establishing processing specifications for each key parameter. Once all of the parameters have been met and documented, the product is ready to ship.

IGS High Tech B.V.

Making life a little bit easier for its customers is one of the highest priorities of mould maker IGS High Tech B.V. (Tilburg, Netherlands). The company recently invested in new equipment designed to optimize in-house mould validation and parts measurement.

“We have installed a second trial injection moulding machine and an OGP SmartScope Flash 400 in our after-sales department,” says sales and marketing manager Jan Willem den Hollander. “And there is still enough room to install a customer’s moulding machine and validate the process in-house.” One recent project resulted in the successful validation of a single-cycle multicomponent moulding process involving rigid and elastomeric materials and in-mould labeling. “By validating the process in-house, we can deliver a production-ready mould to our customers and save them considerable time,” says den Hollander.

The acquisition of the noncontact optical measurement system enables IGS to precisely verify the dimensions of plastic parts. “It’s better than using a contact probe,” says den Hollander. “Because the measurement is done without physical contact, there is no risk of part deformation.”

Copyright ©2005 European Medical Device Manufacturer