Originally Published November/December 2000
EMDM Industry News
Ticona Courts Device Industry at Launch of COC Production Plant
As preparations for Oktoberfest were still under way down south, Ticona GmbH threw a party of its own at its facility near Düsseldorf. The technical polymers branch of chemicals giant Celanese AG officially unveiled the world's first cycloolefin copolymer (COC) production plant to the media and sundry other guests in grand style at the end of September.
Microtitre plates and pharmaceutical packaging are among the core medical applications of Ticona's cycloolefin copolymer marketed under the name of Topas.
Set within the sprawling Ruhrchemie site in Oberhausen, Germany, the plant has an annual production capacity of 30,000 t of Topas, as the material is branded. A fair portion of the output is targeted at the medical device industry. In fact, Ticona expects to see demand for its resins grow faster in the medical market than in the traditionally robust automotive and mobile phone sectors, according to CEO Edward Muñoz. The reason resides in the metallocene-catalyzed material's combination of optical clarity, biocompatibility, moisture barrier properties, and heat resistance.
Currently, Topas 8007 is used to produce blister packs for Bayer aspirin tablets. Bayer AG had been seeking a material that offered moisture protection and clarity for packaging products marketed in tropical regions. The company initiated suitability trials in 1996 to test the material, which was then being produced at a pilot plant. Two years later, Bayer was satisfied that Ticona's COC offered the best combination of price, performance, and processability, and it has been running Topas on a blister pack machine in Indonesia since 1999.
The low glass transition temperature of Topas and its moisture barrier properties prompted Bayer to specify the material for its blister packs.
A key feature of Topas 8007, according to Alexandra Jacobs, Topas's global segment leader–medical and diagnostics, is its low glass transition temperature, which enables rapid throughput on packaging lines. "It can be processed at a glass transition temperature of 80°C," notes Jacobs, "while producing uniform blisters with a constant wall thickness." Blister packaging, flexible films, and rigid packaging applications account for more than 50% of Topas's current market.
The new Topas plant at the Oberhausen Ruhrchemie site has a production capacity of 30,000 t per year.
The material's optical clarity has resulted in a unique application for a polymer, adds Jacobs. A manufacturer of 96- and 384-well microtitre plates recently specified Topas as a replacement material for the quartz glass that was traditionally used. "Quartz glass is expensive," notes Jacobs, "and because [the plates are] used multiple times, there is always a risk of cross-contamination." Until the advent of Topas, however, the company felt it had no alternative but to continue using quartz glass because it was critical that the material provide UV transparency at low wavelengths. "Topas is the only polymer with UV transparency at the 240–260-nm wavelength," says Jacobs, "thus enabling production of single-use microplates."
Other current applications for the material include prefilled syringes and containers. The material's transparency and its compatibility with most sterilization methods make it suitable for use in the production of injection-moulded syringes and blow-moulded vials.
Ticona has established US FDA drug and device master files for the USP Class VI material.
An information package on the use of engineering plastics in medical technology is currently accessible on Ticona's Web site . The site shows how Topas and the company's other materials are routinely used in the manufacture of inhalers, minimally invasive forceps, and related devices. If you're interested in finding out more, don't delay: The company has announced that this section will be publicly viewable only until the beginning of December.
For further information, contact Ticona GmbH, Information Services, D-65926 Frankfurt, Germany; phone: +49 69 3057063; fax: +49 69 30582802; e-mail: jacobs@ticona.de.
—Norbert Sparrow
Microsystems Developer Harvests Incuctive Sensor Technology
The race to capitalize on potential markets for microsystems continues at a swift pace. Hot on the heels of a trans-Atlantic partnership to commercialize microelectromechanical systems (MEMS) technology, TMP (Enschede, Netherlands) has announced a collaborative agreement with the CSEM Centre Suisse d'Electronique et de Microtechnique (Neuchâtel, Switzerland). The agreement provides TMP, which develops and commercializes microsystem products worldwide, with access to CSEM's inductive position sensor technology.
CSEM's technology reportedly combines the advantages of silicon integration with the inductive sensing principle. Conventional inductive noncontact position sensors typically are fitted with resolvers and linear variable differential transformers, which incorporate bulky coils that resist miniaturization. Alternative integrated resistive-type sensors can meet demanding size requirements, but they may not achieve the performance and ease of mounting requirements that many industries demand. CSEM has developed microsensors that use coil-on-chip technology to overcome these limitations.
"These sensors are typically used in motors and motion control products," says Johan Bergqvist, CSEM senior manager. "One recent medical application involves the motor for a heart-lung machine. Because the sensor is particularly robust and withstands harsh environments while maintaining good resolution, it may have several other applications in medical equipment," adds Bergqvist.
Sensors used in the motor of a heart-lung machine combine the advantages of silicon integration with the inductive sensing principle.
For its part, TMP collaborates with foundries and assembly experts to supply customers with seamless design-to-production solutions. It also has a long-standing relationship with the MESA+ Research Institute, also in Enschede, which performs substantive R&D work in MEMS and microsystems. "The combination of CSEM's sensor know-how and TMP's microsystem engineering expertise will result in reduced time to market, less risk, and lower development costs for our customers," says Hans van den Vlekkert, TMP vice president of sales.
For additional information, contact TMP, P.O. Box 318, NL-7500 AH Enschede, Netherlands; phone: +31 53 4800111; fax: +31 53 4800119; e-mail: info@microproducts.nl; or CSEM S.A., Inductive Sensors Group, CH-2007 Neuchâtel, Switzerland; phone: +41 32 7205111; fax: +41 32 7205763; e-mail: inductive@csem.ch.
—Norbert Sparrow
AngioDynamics Ltd. Now Provides Contract Manufacturing
AngioDynamics Ltd. (Enniscorthy, Co. Wexford, Ireland) now offers contract design and manufacturing for OEMs in addition to its catheter product lines. The change follows the company's recent spin-off from AngioDynamics Inc. (Queensbury, NY, USA). The Irish company was purchased by its management in July after AngioDynamics Inc. announced its plans to exit the cardiovascular market.
"We are in the process of making the switch from being primarily a product provider to being a solutions provider," says Andrew Jones, AngioDynamics Ltd.'s managing director. "Customers and employees alike are excited about the transition." In fact, customer feedback about the split from AngioDynamics Inc. has been overwhelmingly positive, according to Jones. "Our customers are delighted. They are now more confident in our service, because we're primarily focussed on this segment of the business for the long term."
The HSC135 stent delivery catheter is the newest addition to the AngioDynamics Ltd. product line.
AngioDynamics Ltd. primarily manufactured PTCA catheters, coronary stents, and specialized pressure injectors for AngioDynamics Inc. According to Jones, the company is confident in its ability to succeed as its own entity due to its previous experience producing and marketing products directly from Ireland. The company is also developing additional balloon sizes, catheters with improved technical innovations, and a range of stent delivery innovations to accompany the current product line. The HSC135 family of PTCA catheters and stent delivery systems will be at the core of the product line. Features of the HSC135 line include a high-pressure, semicompliant balloon; trifold memory; kink-resistant transition capabilities with improved pushability; a hypotube shaft; a low crossing profile; and rapid inflation and deflation.
The company will continue to supply AngioDynamics Inc. with pressure injectors and various disposable products for two years. During this period AngioDynamics Ltd. may retain its name, but Jones says the company is already working on a name change that will denote its new full-service identity.
The company plans to immediately focus its efforts in Europe, but also has its sights set for global distribution after the transition period. "We need time to develop our identity, while maintaining continuity with our current customer and supply base," Jones says.
For more information, contact AngioDynamics Ltd., Moyne Upper, Enniscorthy, Co. Wexford, Ireland; phone: +353 54 37111; fax: +353 54 37100; e-mail: info@angiodynamics.ie.
—Jamie Graham
Thermoform Packaging Machine Allows for Toolless Changeover
A new medical thermoform packaging machine allows different pack sizes to be produced without changing the seal head tooling. Shown for the first time at the Processing and Packaging Machinery Association trade show in Birmingham, UK, the MT2500 from Doyen Medipharm Ltd. (Barton, Cambs, UK), is the first thermoform packaging machine that fully validates sealing dwell time, temperature, and pressure.
Alan Isaacs, chairman of Doyen Group plc, states that the packaging machine was created because "thermoform machines are not inherently versatile. They do not allow different pack sizes to be produced on one machine without tool changes, due to the need to change or adapt the forming and sealing stations as applications vary." To solve this problem, the MT2500—capable of forming, filling, and sealing—comes with quick-change tooling, a servomotor drive, and touch screen controls for rapid changeover and high flexibility. The machine's design allows for web widths from 8 to 20 in. that can be changed on-line, repeats up to 20 in., and draws depths down to 5 in.
The MT2500 thermoform packaging machine enables manufacturers to mass-produce a large number of different products on one machine.
According to Doyen, the MT2500 is most effective in packaging large and bulky items that necessitate a high-integrity seal required by the medical manufacturing industry. The toolless changeover capability removes the need to purchase extra sets of tooling or another machine to accommodate multiple pack sizes. Well suited for high-volume packaging, the machine can achieve web speeds of up to 600 in./min, or 30 cycles per minute, and is GMP compliant and CE marked. The MT2500 also features a web tension control and sealing mechanism that improves sterile seal quality, reduces material waste, and increases production throughput.
For more information, contact Doyen Medipharm Ltd., Cavendish House, Cambridge Rd., Barton, Cambs CB3 7AR, UK; phone: +44 1223 264300; fax: +44 1223 264411.
—Katherine Sweeny
MEDTEC on the Move
Canon Communications llc has announced plans to expand its line-up of MEDTEC European trade events. The company, which has produced co-located and stand-alone shows in Germany and the Netherlands since 1991, will launch a new conference and tabletop exhibition in Ireland in 2001, and return to Germany in 2002.
The premier subcontracting show and conference for the European medical device industry, MEDTEC will be held in Stuttgart, Germany, on 5 to 7 March 2002. Stuttgart is located in the heart of Germany's medical device industry, which represents approximately 14% of the world market for devices, notes the show organization. "A stand-alone pan-European event remains the core of our European strategy," says trade show director Diane O'Connor. "Where market conditions warrant, as in the case of Ireland, we will organize regional conferences to serve supplementary market niches," she adds.
Debuting on 19–21 September 2001 in Galway, the first-ever MEDTEC Regional Conference will consist of interactive sessions on topics of specific relevance to device manufacturers. A tabletop exposition featuring the products and services of a select group of international suppliers will complement the conference.
Canon Communications llc, which also publishes EMDM, organizes trade events worldwide, including the Medical Design & Manufacturing exhibitions and conferences, Atlantic and Pacific Design & Manufacturing, and OEMBoston.
For additional information on the MEDTEC events, contact Mark Temple-Smith, Canon Communications llc, P.O. Box 975, Bottisham, Cambs CB5 9SF, UK; phone: +44 1223 813660; fax: +44 1223 813661; e-mail: mark@cancom.co.uk; Internet: www.medtecshow.com (Stuttgart) and www.medtecireland.com.
Glucose Monitoring Technology to
Accompany Implantable Biosensor
A supplier specializing in medical electronics is participating in the development of an implantable glucose biosensor for diabetics. Synthetic Blood International Inc. (SBI; Ketterling, OH, USA) and UMM Electronics Inc. (Indianapolis, IN, USA) recently announced the partnership to codevelop the implantable glucose biosensor and its handheld monitoring unit. UMM, a contract developer and manufacturer, is responsible for designing the monitoring unit and miniaturizing SBI's implantable biosensor.
The biosensor sends signals to the receiving and transmitting unit, which is roughly the size of a pager. This monitoring unit collects and stores at least 30 days' worth of glucose level readings and alerts the user by an audio signal or by vibration when glucose levels drop too low. In addition to receiving biosensor transmissions, the unit is also used to calibrate the implanted biosensor.
SBI's biosensor eliminates the need for frequent finger sticking, and should increase accuracy compared with existing devices. "Most current glucose monitoring devices measure within an accuracy of ±10%, and sometimes ±20%," says Elmo Blumbaugh, SBI manager of biosensor research and development. "We are planning on providing much higher accuracy and reproducibility of measurement." SBI president Robert Nicora says the company chose UMM to help with the design of the monitoring unit because of its extensive experience manufacturing products for the diabetic market.
Russ Gray, UMM vice president, agrees that glucose monitoring technology is nothing new to UMM. "Having manufactured 9 or 10 million glucose monitors, we have more experience with glucose monitor manufacturing than any other company in the world."
UMM specializes in medical electronic device technology, and its products range from handheld battery meters to point-of-care analyzers. UMM's most recent completed project is a point-of-care analyzer for Careside Inc. (Culver City, CA, USA). The device was one of the 29 finalists in the 2000 Medical Design Excellence Awards organized by Canon Communications llc.
SBI holds two patents in the United States for the biosensor technology and has a patent pending in Europe. Ultimately UMM's sister company, LRE Technology Partner GmbH (München), may also be working on the project. UMM and LRE are both divisions of Leach Technology Group.
For more information, contact UMM Electronics Inc., 6911 Hillsdale Ct., Indianapolis, IN 46250, USA; phone: +1 317 5765035; fax: +1 317 5765044; e-mail: info@UMMelec.com.
—Jamie Graham
Diagnostic Supplier to Promote Custom Conjugation Services
A manufacturer of immunogold and silver reagents for diagnostic and research applications plans to offer sample gold conjugation services to potential customers at Medica, which runs 22–25 November in Düsseldorf, Germany.
British Biocell International (BBI; Cardiff, UK) uses antibodies or antigens provided by a customer to perform an appraisal of an antibody's suitability and then create a gold conjugate that provides optimum sensitivity and stability. The company also ensures that the new conjugate is capable of large-scale production.
A comparison test will be provided free to the company's future custom conjugation customers. Companies wishing to compare and evaluate their current conjugate can benefit from a report issued by BBI's research team. Using transmission electron microscopy, the report will assess conjugate OD, sensitivity, and clustering, together with the size and CV of the colloid particles, and draw a comparison between the current conjugate and BBI's new conjugate. The comparison will also include photographic images taken by the electron microscope.
Highly clustered gold conjugates such as the one above may cause instability and reduced accuracy in diagnostic processes.
Images of the gold conjugate, when magnified up to 100,000x, can delineate the characteristics of the conjugate and identify potential problems. Problems associated with highly clustered gold include instability and the occurrence of false positives.
For more information, contact British Biocell International, Golden Gate, Ty Glas Ave., Cardiff CF4 5DX, UK; phone: +44 1222 747232; fax: +44 1222 747242; e-mail: info@britishbiocell.co.uk.
—Benjamin Lichtman
In Brief
Two German Notified Bodies Merge
Mdc medical device certification GmbH, originally located in Memmingen, Germany, recently relocated to Stuttgart, Germany, after announcing its merger with ZDH-Zert e.V. (Stuttgart, Germany), another notified body. Now known solely as mdc medical device certification GmbH, the merged company inhabits ZDH-Zert's facilities. Mdc, which provides certification services and updated regulatory information for medical device manufacturers, plans to enlarge the Stuttgart facilities.
For more information, contact mdc medical device certification GmbH, Heilbronnerstr. 43, D-70191 Stuttgart, Germany; phone: +49 711 2535970; fax: +49 711 25359710; e-mail: mdc@mdc-ce.de.
Upchurch Scientific Acquired
Upchurch Scientific (Oak Harbor, WA, USA) was recently sold to KRG Capital Partners LLC (Denver, CO, USA), a private investment firm. Upchurch specializes in precision injection moulding and the machining and extrusion of engineering thermoplastics. Products offered include close-tolerance fluid-transfer fittings, tubing, and accessories. The acquisition has not changed the company's core activities.
For more information, contact Upchurch Scientific, 619 W. Oak St., P.O. Box 1529, Oak Harbor, WA 98277, USA; phone: +1 360 6792528; fax: +1 360 6793830; e-mail:upchurch@upchurch.com.
Spire Biomedical Receives ISO 9001 Certification
Spire Corp. (Bedford, MA, USA) received ISO 9001 certification from TÜV Rheinland of North America for its biomedical processing services and manufacturing division. The company offers surface-engineering treatments for implantable medical devices and is preparing a line of catheter products for CE mark acceptance.
For more information, contact Spire Corp., One Patriots Pk., Bedford, MA 01730-2396, USA; phone: +1 781 2756000; fax: +1 781 2757470; e-mail: email@spirecorp.com.
—Jamie Graham
Web-based Biotechnology Glossary Available
A searchable version of Technomic's Glossary of Biological Terms is available on-line. The glossary is designed for anyone with an interest in biotechnology, particularly persons who haven't been formally trained in the field. The site has various features to enhance the user's search, including a reference chain that allows visitors to identify and find other definitions of related terms. The site also has links to find other occurrences of a term within the glossary.
Hardcoated Films Supplied Through E-catalogue
Customer service and ordering capabilities for hardcoated films are available at www.tekra.com. Users can access Tekra Corp.'s e-catalogue using a customer identification number and a password. After logging in, they can search for parts, view current and past orders placed on the site, and input new orders electronically. In addition to the on-line product catalogue, the site also contains sections devoted to polycarbonate and polyester films, adhesives, hardcoats, label stock, and digital films.
Kimal Launches Site
Kimal plc (Uxbridge, Middx, UK) recently launched its Web site at www.kimal.co.uk. The site provides information on Kimal's contract manufacturing services and cardiology products. Features like news and events, services, and contact information are also included on the site.
—Jamie Graham
