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With healthcare needs on the rise, medical OEMs are turning to plastics to create safer, more innovative products, and to minimize business costs. Eastar™ Copolyester MB002 was selected for the redesign of Artegraft Inc.’s 21-inch glass culture tube used to package the company’s collagen vascular grafts. An occurrence of breakage during transportation prompted Artegraft to develop a stronger, more resilient package to protect its medical device used as a hemodialysis graft or for peripheral bypass.
Instead of the glass tube’s cylindrical shape, the new plastic culture tube has a flat side so it will not roll and potentially fall, thereby damaging the graft packaged inside. For ease-of-use, the diameter of the neck opening was increased, and a peel-away, heat-shrink tamper evident seal was added. Each new tube is embossed with the Artegraft name on the outside.
“The packaging expertise of O.BERK Company coupled with the performance of Eastar™ Copolyester MB002 created the best possible solution for our conversion from glass to plastic,” said Laurence A. Potter, Vice President of Scientific Affairs from Artegraft. “Now we have a more robust, stable, and safer package that does not compromise the surgical readiness or performance of our grafts. ‘Secondary packaging costs can be decreased as well as transport, warehousing, and other expenses as a result of the switch to plastic.”
The medical grade Eastar™ Copolyester MB002 is a resin specifically developed for extrusion blow molding containers in medical applications where aesthetics such as high clarity and gloss, coupled with high toughness and chemical resistance are desirable. Relevant testing has been performed on samples of this resin after Gamma and EtO sterilization according to protocols from ISO 10993, Biological Evaluation of Medical Devices, and USP <88> monograph (Class VI), Biological Reactivity Tests.
Additionally, the Eastar™ Copolyester MB002 resin is compatible with the same sterility and validation processes used for Artegraft’s existing glass tubes, which passed FDA review criteria.
“Aside from its stellar manufacturing properties, Eastar’s™ proven alcohol resistance ensures the plastic will not absorb into Artegraft’s sensitive product,” said David Gotler, Director Technical Services from O.BERK Company. “Essentially we found a plastic that mirrored the advantages of glass, allowing Artegraft to respond quickly to medical industry needs with a sound patient product.”
Eastman’s medical market segment team provided expert consultation about Eastar™, and just-in-time delivery of resin to the blow-molder to meet production deadlines. The Eastman team fast-tracked their role in the project—they were an excellent, critical partner for the success of the new package,” commented Gotler.
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