The Cryovac division of Sealed Air Corp. will open a new plant to boost capacity for its polyolefin pharmaceutical films, a growing segment tapping into global health concerns.
Duncan, S.C.-based Cryovac is among a handful of companies girding for what they anticipate will be a switch away from PVC in intravenous bags.
Major bag producers Baxter International Inc. and Abbott Laboratories Inc. are under growing pressure to make the conversion in North America, said Michael Troedel, director of sales and marketing for medical products with Cryovac competitor Pactiv Corp. of Lake Forest, Ill.
``Neither of the two big players, Baxter and Abbott, are rushing to switch materials,'' said Troedel, whose company makes polyolefin medical bags in Halle, Germany. ``There's going to have to be some event, either regulatory or public pressure, to force them to do it. The rest of the world already realizes it and is making the switch.''
But with hospital groups and the Food & Drug Administration concerned about a plasticizer commonly used in PVC bags, Cryovac is ramping up capacity for polyolefin medical film at its Duncan campus.
The company said Sept. 5 that it will start work on a 20,000-square-foot plant. The facility will complement an existing polyolefin medical bag facility in Duncan and provide the capacity needed to meet growing needs, said Stephen Schultz, general manager of Sealed Air's medical products division.
The building will be completed by the end of this year and Cryovac will install a coextrusion film line by the end of 2003, said Cryovac marketing manager Chip Bolton. About 20 employees will be added at the new facility, he said.
Neither Cryovac nor Sealed Air would disclose the cost of the project.
While the facility will focus primarily on film production, it will include converting operations to create complete form-fill-seal bags for intravenous uses.
Other pharmaceutical uses for Cryovac's medical film include parenteral nutrition bags, irrigation bags and both peritoneal dialysis and specialty drug products, Schultz said.
Companies are looking into PVC alternatives because of safety concerns about leaching of di(2-ethylhexyl) phthalate plasticizer.
In July, the FDA recommended that hospitals reduce some patient exposure to DEHP. The agency also has said that for most people, there is no risk from DEHP exposure from medical devices.
``We're seeing a rise in customer preference for non-PVC IV bags,'' Schultz said. ``There is growing concern here. European markets have been more sensitive in the past to environmental issues than has the U.S. market, but the market response is growing.''
Large medical-products makers are feeling the pressure to move away from PVC film, said Shari Sandberg, marketing director for pharmaceutical products with B. Braun Medical Inc., a maker of polyolefin IV bags based in Irvine, Calif.
``Very recently, the movement [to non-PVC medical bags] has gone gangbusters,'' Sandberg said. ``The FDA's [health notification] has made a big difference for us.''
Still, Baxter and Abbott will take some convincing before making a shift, Troedel said. Both have significant investments of their own in PVC film products.
Pactiv also has talked about opening a polyolefin medical-film facility in North America, he said. The company is evaluating the market and both Baxter and Abbott's positions, he said.
``The FDA position paper has put them properly on alert,'' Troedel said. ``The pressure is there.''