Eastar Copolyester Selected as an Alternative to Glass Packaging of Artegraft's Vascular Graft
Eastman Assists O.BERK Company and Artegraft Inc. on Redesign of Culture Tube Packaging to Increase Safety, Usability, and Cut Costs
KINGSPORT, Tenn., July 10, 2007- With healthcare needs on the rise, medical OEMs are turning to plastics to create safer, more innovative products, and to minimize business costs. Today Eastman Chemical Company (NYSE:EMN) announced that its 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.
Also involved in the development of the new application was FGH Systems Inc., (www.fghsystems.com), a designer and manufacturer of extrusion blow molds, who supplied the culture tube samples which the customer used for extraction and stability testing. Meredith Springfield (www.meredithspfld.com), a plastic molder, provided sophisticated quality assurance, and ran the first commercial production order. In addition, National Novelty (www.nnbc-pa.com) supplied the 28mm Urea Closures.
About Artegraft
Artegraft, Inc. (North Brunswick, NJ) was incorporated in January, 1993, upon the divestiture of the vascular graft business from Johnson & Johnson. The company is privately held, in the majority by McGuggan LLC, a private investment group in Morristown, New Jersey.
Artegraft is a biological vascular graft and was among the first vascular grafts approved by the FDA, and in continuous clinical use for over 37 years. Artegraft is classified by the FDA as a Class III, life-sustaining implantable device.
Artegraft's natural collagen matrix, as well as its surgical versatility and compliance, has proven long-term patency advantages over synthetic graft materials. Artegraft is also positioned as an alternative to a non-viable autogenous fistula, where the patient's own artery & vein are joined together to create a conduit for hemodialysis access. For more information please visit www.artegraft.com
About O.BERK Company
For nearly 100 years, O.BERK Company has been a major full-service supplier of glass, plastic, and metal containers; metal and plastic closures; and a total packaging resource for the personal care, healthcare, food & beverage, chemical & industrial, and specialty markets. The O.BERK family of packaging companies maintains full-service facilities in Union, NJ, West Haven, CT, Baltimore, MD, and a sales office in Mineola, NY. For more information on our products and services, visit us at OBERK.com.
About Eastman in the Medical Market
For more than 65 years, Eastman plastics have been used in a wide range of medical non-implantable device and packaging applications that meet the performance demands and regulatory requirements of the medical industry. Our diverse product line of DuraStar and Eastar copolyesters, Eastalloy blends, Ecdel elastomers, and Tenite cellulosics provides a broad range of properties that deliver application performance and flexibility in sterilization techniques. Eastman has enjoyed the trust of the industry's foremost innovators, and we continually collaborate with our partners throughout the industry to develop medical devices and packaging on the cutting edge of science. For more information, please visit eastman.com/medical.
About Eastman Chemical Company
Eastman Chemical Company (NYSE:EMN) manufactures and markets chemicals, fibers and plastics worldwide. It provides key differentiated coatings, adhesives and specialty plastics products; is the world's largest producer of PET polymers for packaging; and is a major supplier of cellulose acetate fibers. As a Responsible Care® company, Eastman is committed to achieving the highest standards of health, safety, environmental and security performance. Founded in 1920 and headquartered in Kingsport, Tenn., Eastman is a FORTUNE 500 company with 2006 sales of $7.5 billion and approximately 11,000 employees. For more information about Eastman and its products, visit www.eastman.com.
Steven J. Nussbaum
O. BERK Company
(800) 631-7392
marketing@oberk.com
