Originally Published EMDM October 2001
REGIONAL FOCUS
Herrmann Ultrasonics
A range of equipment for the processing of nonwovens and thermoplastic parts is supplied by Herrmann Ultrasonics (Karlsbad). Equipment for nonwoven processing is suitable for the production of medical disposables. Cutting and bonding in length and cross direction are achieved in one step. Multiple layers of different materials can be bonded, and multilayer products can be laminated. Slitting, die-cutting, and perforating in both length and cross direction can be performed at high speeds.
Herrmann's ultrasonic welding equipment for thermoplastic components employs digital technology to control the welding process precisely, resulting in high-strength joints with repeatable results. A menu-driven operating system permits easy adjustment of welding parameters without complex programming.
Closed-loop control of the entire welding process ensures optimal quality and repeatability. The company's product line includes stand-alone presses, customized workstations, components for automation and packaging systems, and noncontact rotary systems for nonwoven materials. Customized application tests are conducted in the company's laboratory, where anvil drums with different patterns can be used.
Braun Formenbau GmbH
Technical plastic parts and injection moulds are produced in small or large quantities by a supplier in Bahlingen, near the heart of the Black Forest. Products include bottle pack caps in polypropylene, injection systems, and closure systems. The firm will undertake moulding, or tooling projects, or both.
The company, Braun Formenbau GmbH, has a Class 10,000 cleanroom for the production of medical and pharmaceutical components. Testing facilities are located on-site, and the company has made considerable investments in vision and measurement systems for quality assurance. Braun does not flinch when faced with complex projects; the company reports that about half of its production is dedicated to moulds for two- or multiple-component plastic parts with different material pairings.
The firm began in 1977 as a mould shop with four employees, and it has experienced significant growth in recent years. "We learn a lot from our customers," says Holger Fries, production manager for pharmaceutical products, adding that the company meets with its clients every 4 months. According to Arno Gut, management assistant, the company wants to expand its medical activities.
Braun's current cleanroom measures 200 m2. An enlargement of the cleanroom to 425 m2 is anticipated by the end of the year, accompanied by the addition of more than 20 new injection moulding machines.
Epflex Feinwerktechnik GmbH
Although it is only 7 years old, Epflex Feinwerktechnik GmbH (Dettingen/Erms) has made a strong entry into the device market, with more than 90% of its business focussed on medical projects. The company is a specialist in nitinol applications, such as PTCA guidewires, baskets, filters, and coils. Flexible endoscope heads, mandrels, and stylets are also produced.
Epflex's guidewire components are joined using laser welding or UV adhesives. Welding operators are equipped with video monitors for quality control. Products can be supplied uncoated or coated with biocompatible materials. PTFE and hydrophilic coatings can be preapplied or spray coated.
Uwe Stoll, head of R&D and international sales, explains that the firm's small size affords it a certain agility in meeting the needs of just-in-time manufacturing. "Our main advantage is that we have a short reaction time," he says. The company recently broke ground on an expansion project that will triple the size of its production facilities.
Müller + Kurtz
The first thing that you'll notice upon entering the production facility of Müller + Kurtz Sondermaschinen GmbH (Winterbach) is a strikingly modern reception area. Chances are, you'll then be greeted by the very pleasant Elvira Stegmeyer, assistant to the CEO, who will show you around the 7000-m2 facility, where automatic linear assembly machines are manufactured for cleanroom applications in lengths up to 9 m.
Stegmeyer explains that the company's first medical applications were syringes and infusion sets. "Since then, we have received a lot of syringe inquiries from all over the world," says Stegmeyer. Spurred on by the successful completion of recent projects, the company is interested in expanding its activities in the medical sector. The firm's employees are trained in US FDA and GMP guidelines.
"We're used to handling complex projects with up to 25 components," says Stegmeyer. Müller + Kurtz is currently constructing a line for the assembly of blood-analysis equipment. The project, which is being undertaken for Hoffman-Laroche (Basel, Switzerland), integrates quality assessment systems into the assembly line. Future projects will include a machine for the production of disposable safety syringes.
sortimat Technology GmbH & Co.
Automated precision assembly machines are produced for the medical industry at sortimat Technology GmbH & Co. (Winnenden). Typical applications include assembly lines for the production of syringes, inhalers, and infusion kits. Packaging machinery can be integrated into these lines.
One interesting project in progress is a machine to assemble needleless injection devices. Vice president Michael Kanzler says that the challenge of the project lies in the complexity of the part being assembled, the required speed, and the integration of various industrial processes such as cutting, welding, and ultrasonics. He adds that sortimat developed a special blade to cut the end of the component to a 0.2-mm diameter. "Laser cutting does not work for this product, because it closes the hole," he says. "Above a diameter of 0.3 mm, [the injection device] causes pain to the patient," he says, adding that it is impossible to make a needle that small. Following the cutting process, sortimat's machine uses vision equipment to perform quality assurance.
According to Kanzler, this kind of highly integrated assembly line is not unusual in the company's medical and pharmaceutical work. He cites a project where three machines were integrated for an inhaler product: two for assembly and one for testing.
Kanzler notes that the company works with several local suppliers in Baden-Württemberg that produce, among other things, testing and quality assurance equipment. The company can validate its assembly machines upon request.
Physik Instrumente GmbH & Co.
Displayed at the Hannover Messe in April, F-206 six-axis compact micropositioning equipment from Physik Instrumente GmbH & Co. (Waldbronn) is suited for use in MEMS positioning, optical device testing, and micromachining of components for microsurgery.
The company reports that the F-206 is the result of almost 10 years of experience in the design and manufacture of hexapod micropoitioning systems. The unit provides six degrees of freedom and 0.1-µm resolution, and allows the user to define the pivot point anywhere inside or outside the F-206 envelope. Rotation about the pivot point can be specified for any axis.
The F-206 is considerably more compact and accurate than conventional multiaxis stage stacks. Its novel parallel-kinematic design and all-digital controller automatically compensate for unwanted and parasitic motions. The unit is immune to orthogonality and crosstalk issues that pose a formidable assembly and service problem to stacked units. An optional nanocube ultra-high-resolution piezo scanning and alignment module is also available for the unit.
Kroma GmbH
An injection moulder offers thin-wall and two-component moulding services to medical manufacturers. Kroma GmbH (Lahr) has patented an inlay moulding process that combines moulded plastic and metal parts in one shot. No welding is required, and the resulting parts are air- and watertight. "This process saves our clients time and money, and it's accurate as well," says Angela Gwinner, marketing manager at Kroma. She adds that previous methods required up to five steps to achieve the same result.
Although the technique has yet to be applied to medical products, the firm reports that it is in negotiations with several medical OEMs, and that it has seen an increase in inquiries from the medical sector in recent years.
The company excels in design and prototyping. Moulds are designed with state-of-the-art CAD software, including AutoCAD, Mechanical Desktop, and Pro/Engineer. Where 3-D data are not available, hardware parts can be digitalized. The firm's 3-D design and development team prides itself on its expertise and precision.
Parts weighing 0.2 to 4000 g are injection moulded in thermoplastics, elastomers, and PEEK and other technical plastics. Machines with clamping forces from 25 to 800 t are available and can be integrated with pick-and-place systems, automated assembly equipment, and centralized material supply stations.
Greiner Bio-One GmbH
In Frickenhausen, specialized laboratory products are manufactured for the medical industry, as well as for applications in biotechnology, research, and chemical analysis. The firm recently cooperated with a diagnostics company to produce the OncoQuick, a novel tumor cell enrichment device. Greiner Bio-One GmbH produced the tube, the screw cap, and the filter disc for the device.
In addition, Greiner offers expertise in microsystems for the mass production of microfluidic arrays used in high-throughput drug screening, clinical diagnostics, and gene analysis. In collaboration with the Forschungszentrum Karlsruhe, the company developed a single-use plastic capillary electrophoresis array in a standardized microplate footprint.
Willy Rüsch AG
Specializing in what it calls "the pathways into the body," Willy Rüsch AG (Kernen) is a manufacturer of finished catheter and intubation products that also offers OEM services to device manufacturers. Its parent company was named after its founder, August Rüsch, who invented the flexible catheter after serving a commercial apprenticeship at a surgical supply store in Karlsruhe. Today, Rüsch International has eight production sites, and is active in several fields, including anaesthesia, urology, ENT, and surgery.
The Rüsch Instrument Service adapts standard articles to meet the requirements of medical OEMs. The company possesses detailed knowledge of modern production methods, coupled with extensive experience in the processing of various materials such as silicone, polyurethane, latex, PVC, and rubber. Small- and special-series devices can be supplied.
Göttfert GmbH
A modified capillary rheometer forms the basis of a system for extruding medical implants. Supplied by Göttfert GmbH (Buchen), the Rheo-Tester 1000E is a stainless-steel machine that produces implants by discontinuous die extrusion.
"Compared with injection moulding and continuous extrusion, a discontinuous die extruder offers the advantages of increased process control, low shear speeds, and uniformity of product diameter," says Axel Göttfert, the firm's managing director.
The measuring cell of the Rheo-Tester 1000E consists of a cylindrical feed channel that is connected to a capillary. A thermostat in the measuring cell permits the material introduced to be thermally conditioned and to be discontinuously extruded through the capillary with an applied force of 10 kN.
Based on this technology, Göttfert has produced a high-precision extruder (pictured) for the manufacture of artificial bone and other high-tech materials requiring very tight tolerances.
KNF Neuberger GmbH
KNF Neuberger GmbH (Freiburg, Germany) manufactures a range of diaphragm pumps for such medical vacuum and compressor applications as blood analysis and pressure monitoring, respectively.
The
NMP830 series of compact pumps (pictured) are well suited for both static and
portable equipment and feature a new type of diaphragm that incorporates a structured
design, resulting in a small footprint as well as other benefits.
Copyright ©2001 European Medical Device Manufacturer
