Industry News

European Medical Manufacturing Show Announced

A trade show specifically for Europe's medical suppliers and manufacturers, the Medical Equipment Design & Technology Exhibition & Conference (MEDTEC) will debut 21-23 October in Amsterdam's RAI International Exhibition and Congress Centre. Sponsored by European Medical Device Manufacturer, MEDTEC has received enthusiastic support from EUCOMED and its 21 Pan-European and national organizations. Among them are ABHI, AAPAMED, BVMed, SNITEM, and UAMEC.

According to organizer Canon Communications llc, the event confirms the impact of recent EU medical device directives. "Europe is increasingly becoming a single market for medical products, the world's second largest," says trade show director Diane O'Connor. "MEDTEC launches at precisely the time when this convergence is creating unprecedented demand for medical design and manufacturing technology, as well as regulatory information."

MEDTEC visitors can preview the latest advances in medical-grade materials, assembly components, electronics, machinery, software, systems, services, and more from nearly 200 of the world's leading suppliers. They also have the opportunity to attend a concurrent technical conference, featuring nearly 80 international industry experts speaking on an extensive range of technical and regulatory subjects. Topics covered include business and marketing, distribution and logistics, certification and CE marking, in vitro diagnostics, software validation, materials selection, and medical-grade plastics, among others.

Amsterdam was chosen as the MEDTEC venue because it is one of Europe's "gateway" cities. With its recently expanded international airport offering connections to almost every country in the world, a vast network of modern motorways, and a thoroughly up-to-date communications system, Amsterdam is ideally equipped to serve a transcontinental audience.

For more information, contact MEDTEC, UK Office, P.O. Box 12997, London NW5 2WX, UK; phone: +44 171 4854343; fax: +44 171 2672788.

Pall and Gelman Sciences Merge

Pall Corp. (Portsmouth, Hants, UK), a designer and manufacturer of disposable filters, membranes, and related devices, and Gelman Sciences (Northhampton, UK), a supplier of membranes and IVD components, successfully merged on 3 February. Gelman will operate as a subsidiary of Pall Corp. and will be responsible for the sale of Gelman and Pall products to the medical OEM, laboratory, and specialty-materials markets. "The merger gives our OEM customers access to a wealth of new materials and technical expertise," says Mark Sutter, Gelman Sciences vice president and general manager of the OEM health-care business. New membranes and devices joining the Gelman Sciences OEM product line include Pall nylon and PTFE membranes, disposable respiratory filters, and filters for lipid emulsions.

Gelman Sciences recently introduced the Predator, a polyethersulfone-based lateral-flow diagnostic membrane.

Gelman's newest product, a lateral-flow medium for one-step diagnostic tests, was launched recently at the Medical Design and Manufacturing West Conference and Exposition in Anaheim, CA, USA. Designed for lateral-flow or immunochromatographic assays, the polymer-based diagnostic membrane features improved consistency, processing efficiency, and lower production costs compared to traditional nitrocellulose membranes. The product is also nonflammable, thereby reducing storage, shipping, and scrap disposal costs. The membrane is supplied in a variety of roll widths, cut sheets, and disk sizes.

For more information about the merger or the new Predator membrane, contact Gelman Sciences, Brackmills Business Park, Caswell Rd., Northhampton NN4 7EZ, UK; phone: +44 1604 704704; fax: +44 1604 704724.

Silicone Altimex to Expand Cleanroom Production of LSR Products

Silicone Altimex (Nottingham, UK), a supplier of custom tubing and precision medical components, has announced that it is increasing the size of its cleanroom facility by 25%, from the current 365 m² to 432 m². The company also plans to install a 50-t Arburg 320M injection moulding machine for liquid silicone rubber (LSR), making Silicone Altimex one of only a handful of companies in Europe able to offer LSR injection moulding in a cleanroom environment. This will enable the firm to rapidly manufacture a wide range of precision medical products, such as syringe valves and components for keyhole surgery, to an exceptionally high standard, according to managing director Stuart Hibberd.

In LSR injection moulding, the liquid is transferred directly from a sealed pail into the mould and is not handled until it is in the form of a finished product, explains Hibberd. Even then, he adds, handling may not be necessary in some cases. Because components are platinum cured, there are no catalytic by-products. In addition, the products do not require hand finishing. "For high-volume output, LSR injection moulding is cheaper and quicker--40 sec/cycle is routine--than other moulding methods," says Hibberd.

Hibberd estimates that 70% of the work performed in the current cleanroom is health-care related, and he expects this share to increase in the future. He cites as the primary reasons a growing demand for these products in the world's emerging markets and the use of silicone rubber as a replacement material for latex, which has potentially cytotoxic side effects.

For more information, contact Silicone Altimex, 49 Pasture Rd., Stapleford, Nottingham NG9 8HR, UK; phone: +44 115 9491413; fax: +44 115 9490468.

Medlink, MDMA Form European Alliance

Medlink Europe (Nieuwegein, Netherlands) and the Medical Device Manufacturers Association (MDMA; Washington, DC, USA) have formed a strategic alliance in Europe. According to Jeff Kimbell, MDMA executive director, a shifting regulatory environment has created the need for a partnership that can service emerging transatlantic companies. "These are crucial times for medical device manufacturers," says Kimbell. "Clearly, the rules and regulations being imposed by the US Food and Drug Administration (FDA) have global implications. Any European manufacturer that is currently marketing products in the United States or intends to do so must be aware of laws passed by the US Congress and regulations imposed by FDA," says Kimbell.

Medical Device Manufacturers Association executive director Jeff Kimbell (left) is pictured with Albert Serianni, CEO and chairman of Medlink Europe and the new director of MDMA's European operations.

In addition to disseminating information on laws and regulations that affect the medical device industry on both sides of the Atlantic and monitoring such issues as mutual recognition agreements, the alliance can benefit European members by alerting them to technological advances and providing assistance in market penetration. "By linking up with MDMA," says Albert Serianni, CEO and chairman of Medlink Europe and newly appointed director of MDMA's European operations, "European device companies will have access to a US-based network of MDMA member companies where they can learn about an array of information programs, innovative technologies, and health-care trends."

Medlink Europe, with branch offices in Belgium and Switzerland, offers contract manufacturing, master distribution, and value-added logistics to medical device manufacturers. MDMA is a health-care trade organization that addresses issues dealing with FDA and related US legislative activity that directly or indirectly affects the device industry.

For additional information, contact Albert Serianni, Medlink Europe, Via Motta 23, CH-6850 Mendrisio, Switzerland; phone: +41 91 6469282; fax: +41 91 6469350.

Nelipak Inaugurates New Medical Packaging Plant

A company that specializes in the design and production of thermoformed packaging for the medical sector, Nelipak B.V. (Venray, Netherlands) recently inaugurated a 4500-m² production plant near its headquarters. "We intend to concentrate the production of medical packaging in this new factory, which is equipped with modern Class 10,000 cleanrooms," says managing director Frank Nelisson. The new facility will also accommodate the company's tool shop, he adds.

Nelipak B.V. has moved its production of medical packaging to a new 4500-m² plant. The company specializes in the design and manufacture of packaging for a variety of medical devices.

In addition to the two Venray facilities, Nelipak has a plant in Galway, Ireland, and offices in Belgium, France, and the UK. All of the factories are certified to be in compliance with ISO 9001; the Netherlands-based facilities also comply with EN 46002. In addition to packaging design and production, the company offers contract packaging services and manufactures sealing equipment.

For additional information, contact Nelipak B.V., Maasheseweg 75, NL-5804 AB Venray, Netherlands; phone: +31 478 582001; fax: +31 478 588536.

Plastinord Opens Ultraclean Extrusion Line

Plastinord S.A. (Longue, France) has successfully modified a production line to extrude medical-grade polyester film. The ultraclean facility, reportedly the first of its kind in France, will supply Caroclear MDL 60 film to the European market.

"Extruding film from Eastar PETG copolyester in a controlled environment is new to France," says Plastinord general manager Luc Chavany. "In the past, Europe's medical sector has looked first to the United States for clean packaging film. Now we're in a position to offer an exceptionally clean film as well as customer support to the European medical market," says Chavany.

Packaging film is extruded from medical-grade polyester in what is reportedly France's first ultraclean facility of its type.

In order to run a high-temperature extrusion system while maintaining a dust-free zone, Plastinord had to construct a pressurized tunnel around an existing extrusion line, explains Chavany.

In addition to Caroclear MDL 60, Plastinord supplies films, tubing, and profiles in a variety of materials.

For additional information, contact Luc Chavany, Plastinord S.A., Zone Industrielle, F-49160 Longue, France; phone: +33 241 526182; fax: +33 241 388085.

DuPont Markets Alternative to CFC-Based Solvents

DuPont de Nemours International S.A. (Le Grand Saconnex/Geneva, Switzerland) has introduced a range of cleaning and drying agents designed to replace CFC-based solvents. Described as near "drop-in" replacements for halogenated solvents such as CFC-113 and 1.1.1 trichloroethane as well as HCFCs, the Vertrel product line was developed as a substitute for the ozone-depleting substances that are being phased out under the Montreal Protocol. The new products can also be used as an alternative to perfluorocarbons in some cases.

Designed as a replacement for CFC-based solvents, Vertrel is suited for cleaning plastic- and metal-based medical devices.

Vertrel products are suited for the removal of a large spectrum of contaminants in such applications as printed circuit board assembly, metal cleaning, high-precision cleaning, and displacement drying prior to metalization. They may also be used as carrier fluids for lubricant deposition or as dielectric fluids.

In addition to zero ozone depletion, the products have relatively short atmospheric lifetimes and low global warming potential compared to CFCs. They are nonflammable, have low toxicity, and good thermal stability; their boiling point is 53°C. The cleaning and drying agents will be available in a variety of azeotropic blends to suit specific cleaning requirements. The company recently began production of Vertrel products at its Mitsui Shimizu fluorochemicals complex in Japan to supply the European market.

For additional information, contact DuPont de Nemours International S.A., 2 chemin du Pavillon, CH-1218 Le Grand Saconnex/Geneva, Switzerland; phone: +41 22 7175111; fax: +41 22 7176077.

Inchcape, NSF Offer Joint Services

Inchcape Testing Services (ITS; Andover, MA, USA), a worldwide testing, inspection, and certification company, and NSF International (Brussels), a world leader in public health safety and environmental quality, announced an agreement to allow clients to receive NSF certification and the ETL mark by contacting a single organization. Manufacturers of certain medical products and plastic tubing will be able to obtain both marks by working with the company most convenient to them. (Each mark can only be issued by the relevant certifier, but either company will coordinate the entire request.)

Combined follow-up inspection services, also part of the agreement, will reduce the number of audits. Instead of four quarterly visits from ITS plus an annual NSF inspection, companies will receive four total visits.

"ITS and NSF International have implemented this program for the benefit of our clients," says Eric Birch, president and chief executive officer of Inchcape Testing Services. "To receive the most widely recognized sanitation mark and a product safety certification mark from a globally recognized testing laboratory through one point of contact allows manufacturers to reduce their certification efforts [and] offers them...flexibility."

For more information, contact Margaret Farnes, Inchcape Testing Services, Unit 10, Manfield Park, Cranleigh, Surrey GU6 8PY, UK; phone: +44 148 3268800; fax: +44 148 3267579; Internet: http://www.worldlab.com. Or, contact NSF International--Europe, 148 Ave. Grand Champ, B-1150 Brussels, Belgium; phone: +32 2 7713654; fax: +32 2 7630013; Internet: http://www.nsf.org.