Originally Published EMDM November 2005
SPOTLIGHT
Disposables
Disposable tubing
A contract manufacturer mass-produces disposable lines for monitoring anaesthesia gas and carbon dioxide by coextruding polyethylene/PVC or PVC tubes and assembling male and female connectors. The ISO 9001– and ISO 14001–certified company can perform any kind of manual medical device assembly inside or outside of its cleanroom. Its full range of capabilities includes tube printing; conducting leak, flow, and pull-off tests; packaging for worldwide shipment; and inventory management.
A&G Ltd., Tallinn, Estonia.
Single-use devices
A contract developer and manufacturer of sterile, single-use medical devices provides services from initial product development and design through production and supply-chain management to warehousing and fulfillment. The company also offers regulatory planning and support to facilitate the review and approval process. Injection moulding, automated assembly and packaging, Class 10,000 and Class 100,000 cleanrooms, and controlled manufacturing environments are available in locations throughout North America, Europe, and China.
Avail Medical Products, Luxembourg.
Superelastic alloys
A supplier of superelastic nitinol alloys also processes cobalt alloys, titanium alloys, stainless steel, and some special alloys like magnesium. Products include tubes, round wires, flat and profiled wires, sheet material, and customized components made of shape-memory alloys in the form of spiral springs, flat drawn strips, and wires. The company offers prototyping to volume production services.
EUROFLEX GmbH, Pforzheim, Germany.
Connector for disposable devices
A supplier of passive components and connectors has introduced a connector system suited for devices used in monitoring, self-diagnostic, and tagging applications. The 9257-series I/O is designed to be cost-effective in applications that do not require multiple mating cycles. Cable termination options include single- and double-sided contacts, giving a single- or dual-row plug connection. The connector plug houses 16 contacts in two rows on a 1.25-mm pitch with a 1-A-per-contact rating. Optional customization of the overmoulded cover or parts can also be supplied.
AVX Corp., Fleet, Hants, UK.
Moulded silicone components
A manufacturer produces moulded silicone components such as tubing and hose assemblies, bottle stoppers and sealers, laboratory equipment, and process and storage containers. Made in-house in a controlled environment, the products withstand autoclave and other forms of sterilization, and resist cracking and particle migration. The silicone parts have a working temperature range of –100° to 400°F. Other silicone components can be made to customer specifications, and colours or special markings for identification purposes can be accommodated.
NewAge Industries Inc., Southampton, PA, USA.
Medical disposables
A company manufactures finished medical disposables on a contract basis. Extrusion, injection moulding, and assembly are carried out in Class 1000, Class 10,000, and Class 100,000 cleanrooms. Its complete in-house services include material selection, product development, CE marking assistance, tooling, manufacturing, assembly, packaging, sterilization, and distribution. The company also extrudes multilumen, multilayered, and profile-shaped tubing from most thermoplastic polymers.
Fluorplast Oy AB, Petalax, Finland.
Assembly and packaging services
An ISO-certified and US FDA–registered contract manufacturer specializes in custom assembly and packaging of disposable medical devices, offering a single solution to customers’ outsourcing needs. Its products include a large selection of catheters, tubing, and medical-grade fluid bags. Extruding equipment, RF welding systems, and Class 7 cleanrooms are on-site. Other services such as device integrity testing, packaging development, sterilization management, and 510(k) filing assistance are also available.
Command Medical Products Inc., Ormond Beach, FL, USA.
Radiopaque powders
A special grade of bismuth oxychloride powders are compatible with polymer resins such as nylon elastomer, polyurethane, polyethylene copolymers, and fluoropolymer used in catheter applications. Biron powders can also be used with colourants if tubes of different colours are desired. The proprietary materials are especially suited for catheters used in intravenous or cardiovascular procedures, which require tubing with radiopacity. The firm also offers light-stable Biron powders.
S. Black Ltd., Hertford, UK.
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