In Brief
Isotron Expands Sterilization Capacity
Isotron plc (Swindon, Wilts, UK) has built a new EtO facility in Yorkshire that will significantly increase the company's medical device sterilization capacity. The plant is expected to be fully operational this spring.
According to the firm, a growing demand for EtO sterilization, which offers flexibility in product design and composition, prompted the company to expand. The firm also operates an EtO facility in Ireland, four gamma-irradiation plants, and an E-beam sterilization facility.
For more information, contact Isotron plc, Moray Rd., Elgin Ind. Est., Swindon, Wilts SN2 6DU, UK; phone: +44 1793 511050; fax: +44 1793 432591.
Popper & Sons Earns ISO Certification and CE Mark
Popper & Sons Inc. (New Hyde Park, NY, USA) has received ISO 9001/EN 46001 certification and the CE mark for its luer fittings, specialty reusable needles, and glass syringes. Notified body Medcert (Hamburg, Germany) presented the company with certificates in a ceremony at the recently held Medical Design and Manufacturing (MD&M) West 98 Conference and Exposition (Anaheim, CA, USA). "We are very proud of this accomplishment, which demonstrates our long-term commitment to quality and continued growth in exporting our products," says Joe Popper, president and CEO of Popper & Sons.
For more information, contact Popper & Sons Inc., 300 Denton Ave., New Hyde Park, NY 11040, USA; phone: +1 516 2480300; fax: +1 516 7471188.
Ireland Inaugurates Cross-Border Cleanroom Society
The Irish Cleanroom Society—a group founded by several Irish companies dedicated to expansion of the cleanroom-associated industries in both Northern Ireland and the Republic of Ireland—was inaugurated in a daylong seminar at the University College Dublin on 8 April. Topics addressed included cleanroom procurement, training, and disciplines.
For more information, contact ElectroMat Ireland Ltd., Oranmore, Co. Galway, Ireland; phone: +353 91 790693; fax: +353 91 790694.
Continental Shift in GHTF Leadership
North American regulatory authorities will take over the chairmanship of the Global Harmonization Task Force. Members of GHTF decided at their meeting in Sydney on 15 February during the Global Medical Devices Conference that the chairmanship should change after every three meetings of the group. It has been chaired since its inception in 1992 by Joseph Putzeys of the European Commission's industrial affairs unit, DG III. Bruce Burlington, head of US FDA's Center for Devices and Radiological Health, is expected to be appointed chairman.
PVC Compounder Expands Plant Capacity
Hydro Polymers Ltd. (Newton Aycliffe, Co. Durham, UK), part of the petrochemicals division of Norsk Hydro ASA (Oslo, Norway), is in the midst of a two-year expansion that promises to practically double the plant's PVC resin and compound manufacturing capacity. Norsk Hydro is spending approximately US$8 million to add more than 20,000 t of gel and powder capacity and to improve cost and efficiency in existing operations. Last June, the parent company also implemented spending of more than US$56 million to increase the site's suspension resin capacity.
"This new investment," says Geoff Richards, president of the petrochemicals division of Norsk Hydro, "will enable Hydro Polymers to further expand its market positions in the UK and continental Europe, and to meet the growing demands of our customers in different market sectors. PVC compounding is a dynamic and profitable core business for Hydro Polymers, and this new capital [expenditure] further demonstrates the company's commitment to PVC in general and compounding in particular."
A wide range of both flexible and rigid materials for moulding and extrusion are offered. Products include gamma-irradiation-resistant (GIR) compounds that maintain their colour when subjected to sterilization; elastomeric recovery extrusion compounds (e.g., for peristaltic pump tubing); non-DOP compounds for specialized applications; and a range of frosted, semiopaque finishes. The firm's Hy-vin PVC medical compounds can be utilized in high-clarity extrusion and moulding applications including blood tubing, heart-lung bypass kits, and IV bags.
For more information, contact Hydro Polymers Ltd., School Aycliffe Ln., Newton Aycliffe, Co. Durham DL5 6EA, UK; phone: +44 1325 300555; fax: +44 1325 300675.
Foster Unveils Off-the-Shelf Medical-Grade Compounds
Foster Corp. (Dayville, CT, USA), a specialty compounder for the medical products industry, recently introduced its first line of off-the-shelf medical-grade compounds at the Medical Design & Manufacturing (MD&M) West 98 Conference and Exposition (Anaheim, CA, USA). According to the company, the Fostalon 5000 series of flexible nylon compounds features the ability to fill a void in the flexural modulus data between 80,000 and 255,000 psi while ensuring both dimensional stability and minimal postextrusion shrinkage.
Fully compatible with radiopaque fillers such as barium, bismuth, and tungsten, Fostalon 5000 products are suited for a range of medical applications including catheters, hubs, and shafts. The compounds can be lubricated, imprinted, and reinforced with glass beads and fibres when used for hubs and other moulded devices. Other benefits of the material, which is suited for use on conventional processing and forming equipment, include less moisture absorption than urethanes and some other nylons, and consistent processability and physical-property values.
"We are confident that we may already have off-the-shelf solutions to solve existing problems of medical product manufacturers," says marketing manager Courtney L. Gibbs. "Our next line of standard offerings will include urethanes, antistatic and lubricated resins, polypropylene, polyethylene, polycarbonate, and various blends and alloys."
The company's facilities include a clean environment, a two-stage compounding system, a full testing and development laboratory, a twin-screw extrusion line, an in-house precision injection moulding operation for testing, and warehouse space for customer-supplied resins.
For more information, contact Foster Corp., 329 Lakeville Rd., Dayville, CT 06241, USA; phone: +1 860 7743964; fax: +1 860 7790805.
