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September 22, 2008 02:00 AM

Helix expands clean rooms at 3 U.S. sites

Mike Verespej
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    Helix Medical LLC is expanding clean rooms at its three U.S. plants and has received new ISO certifications for plants in Carpinteria, Calif., and Shenzhen, China.

    ``We have just approved a multimillion-dollar expansion,'' Helix Chief Executive Officer Jorg Schneewind said in a recent telephone interview.

    ``We are also looking at further acquisitions to build a stronger base for our medical business,'' he added.

    Since it was acquired in 2006, Helix has operated as the health-care products division of Freudenberg-NOK General Partnership, the Plymouth, Mich.-based joint venture of Freudenberg & Co. KG of Weinheim, Germany, and NOK Corp. of Tokyo. The Helix division is focused on the medical-device, drug-delivery, health-care, pharmaceutical and biotech industries and specializes in thermoplastic and silicone medical- device components and subassemblies.

    Schneewind said the expansions will increase clean room space by 30 percent in Carpinteria and 80 percent at Helix's Baldwin Park, Calif., plant. The division also is expanding its Gloucester, Mass., operation by 8,000 square feet to add a clean room.

    Schneewind said the expansions most likely will be completed by November.

    ``We already have machinery waiting to be put in at Baldwin Park,'' said Schneewind, who also is general manager of Freudenberg-NOK's specialty sealing products division.

    He estimates that the 72,000-square-foot plant in Baldwin Park will add 30 injection presses for thermoplastic and liquid silicone molding and that the Carpinteria operation will add 15 machines.

    Baldwin Park currently runs more than 40 injection molding machines, with clamping forces from 28-200 tons, and a Class 100,000 clean room.

    ``The expansion will help us grow and meet customer demand,'' Schneewind said. ``We are seeing a double-digit annual growth. If you don't achieve that in this industry, you are doing something wrong.''

    He also said Carpinteria-based Helix is looking at possible expansion locations in the medical cluster between Chicago and Minneapolis, as well as in Europe and Latin America.

    Europe ``is clearly the next expansion for us,'' Schneewind said, while Latin America could be a location for the company to do assembly.

    Both Class 7 and Class 8 clean room space in Carpinteria received ISO 14644 certification. It previously had received ISO 13485 certification.

    The ISO 13485:2003 certification for its Apec Asia Ltd. division in Shenzhen makes that operation ``one of very few'' locations with such certification in China, according to Schneewind.

    ``These new certifications demonstrate our commitment to grow our capabilities as the needs of our customers grow,'' Helix President Thomas Vassallo said in a news release.

    The 35,000-square-foot Shenzhen site was built in 2006 and has a Class 10,000 clean room. It primarily serves U.S. firms.

    ``Currently, what we are producing here gets sent back to the U.S.,'' said Apec Asia's operations vice president, Bob Desiata, in an interview at Medtec China, held Sept. 9-11 in Shanghai.

    ``Our customers do a lot of assembly in the U.S.,'' he noted.

    At the same time, Apec Asia is working to grow a local customer base. Desiata said the plant soon will begin supplying a customer in Suzhou. Apec Asia sees strong local demand, particularly for its silicone-based products.

    ``There is room in there for 11 machines,'' Desiata said. ``As the business dictates, we will grow.''

    Apec Asia also has started to use local Chinese toolmakers, though not for products than require great precision, he said.

    ``We are utilizing them and helping to bring them along,'' Desiata said.

    The expansions are part of the Freudenberg-NOK partnership's overall plan to grow in the medical component and medical-device markets. Schneewind said Helix customers are looking for more comprehensive service from fewer suppliers.

    ``Tier-1 companies want more value-added partners that can do technology development,'' he said. ``We are adding clean room capacity and machine capacity to provide the flexibility and capacity that our customers and the business demands.''

    Plastics News correspondent Lauren Hilgers in Shanghai contributed to this report.

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