In Cooperation with Teknor Apex, Medical Device Manufacturers Have Proven Outstanding Performance of Tubing in Cutting, Hole Punching, Tipping, Printing, and Insert Molding
ANAHEIM, CA, U.S.A., February 15, 2012: Two medical contract manufacturers have demonstrated the ease and precision with which tubing made from Medalist® MD-500 Series medical elastomers can be fabricated in diverse post-extrusion or "downstream" processes, enhancing the suitability of these compounds as replacements for PVC, it was announced at MD&M West by Teknor Apex Company (Booth 2233).
In production runs by Dunn Industries, Inc. (Booth 2941) and Pelham Plastics, Inc. (Booth 2943), Medalist-based tubing exhibited outstanding performance when subjected to in-line cutting to length and secondary operations including hole punching, tipping, printing, and insert molding, according to Elliott Pritikin, senior medical market manager for the Thermoplastic Elastomer Division of Teknor Apex. Tubing samples assembled in these processes will be on exhibit at the MD&M West booths of both contract manufacturers as well as that of Teknor Apex. In addition, Teknor Apex will make an "Innovation Brief" presentation on downstream assembly at 11:00 a.m. on Wednesday, February 15, in Theater 1, Booth 637 / Hall E.
Pritikin pointed out that these successes follow two other recent demonstrations that Medalist MD-500 Series compounds provide a practical alternative to PVC in tubing: 1) demonstration runs by American Kuhne, Inc.(booth 2330) showing the capability of Medalist MD-500 Series compounds for production in high-speed (over 800 ft./min.) tubing lines; and 2) development by Teknor Apex of patent-pending technologies for bonding Medalist-based tubing to traditional connectors.
"Teknor Apex has recognized from the start of its development of Medalist MD-500 Series elastomers that they must perform as well as or better than PVC throughout the long sequence of processes to which tubing is subjected in the real world," said Pritikin. "We interviewed experts throughout the medical device supply chain, including OEMs, to understand the 'Voice of the Customer' requirements, and these became our developmental scoreboard. During the past two years we have steadily progressed in meeting these requirements, including crystal clarity, kink resistance, clamp resilience, PVC-like haptics, extrusion at high speeds, sterilization by gamma irradiation and ETO, bonding assembly in clinical settings, and everyday handling by healthcare workers. Now we have demonstrated ease of fabrication in downstream techniques for medical tubing."
Dunn Industries-which specializes in medical tubing-extruded Medalist MD-500 Series compounds at its Manchester, NH facility. "The Medalist elastomers exhibited a wide processing window and maintained close tolerances," said company president Duane Dunn. "Tubing was easily cut to length in-line with extrusion."
Pelham Plastics (Pelham, NH), which specializes in custom injection molding and assembly of medical devices, readily carried out a variety of downstream assembly techniques with tubing produced from Medalist MD-500 Series elastomers, according to John J. Mackey, president. "The fabrication performance of tubing produced from Medalist compounds was outstanding," Mackey said. "The tubing was easy to work with even in our most innovative techniques, such as hole-punching and tipping, and we were able to carry out every fabrication technique with great precision."
Pelham Plastics reported on these techniques:
● Hole punching posed no problems, even allowing for tube rotation producing a serpentine pattern; though this process is typically difficult for elastic materials because of stretching or tearing.
● Tipping-the process of forming a tapered closure at the end of a tube-was carried out without need for pretreatment or release agents, which would require additional regulatory approvals. "The tipping performance of tubing produced from Medalist compounds was awesome," said Pelham Plastics sales manager Ray Pellerin. "Cycles were fast, there was no sticking, tapers were consistent, and the aesthetic quality of the finished product was excellent."
● Printing was carried out successfully using standard automated corona surface treatment and traditional pad printing with conventional inks. Teknor Apex also has suggested inks that could be used without the need for pre-treatment.
● Insert molding, in which luers were applied to the ends of tubing, involved short cycle times, no tube distortion, and excellent bonding of the tubing to pre-colored luers made either of polypropylene or Medalist elastomers.
Compared with PVC, Medalist MD-500 Series tubing compounds exhibit comparable crystal clarity and mechanical properties; provide similar clamp resilience and resistance to kinking and necking; have a similar "feel"; and are substantially more flexible and significantly less dense than PVC. At the same time they undergo minimal color shift upon heat aging after exposure to gamma irradiation, the most severe type of sterilization. A typical compound in the series, Medalist MD-575, actually exhibits 70% less heat-aged color shift than a gamma-stabilized PVC compound of comparable hardness.
MEDALIST® THERMOPLASTIC MEDICAL ELASTOMERS make up a broad array of high-purity styrenic, olefinic, vulcanizate, and alloy compounds. Hardness offerings range from ultra soft gels at 25 Shore OO to hard yet ductile compounds at 85 Shore D. Teknor Apex can further broaden customer options by customizing the surface aesthetics, haptics, clarity, and color. An expandable registered binder on Medalist products provides a comprehensive body of test data and resources for designers and processors and is available to qualified professionals in the medical device and healthcare product industries. It can be requested from the Medalist website at www.medalistmd.com or by emailing Teknor Apex at firstname.lastname@example.org.
The Thermoplastic Elastomer Division of TEKNOR APEX COMPANY is the most diversified manufacturer of TPEs, offering broad product families based on six generically distinct chemistries. Headquartered in Pawtucket, Rhode Island, U.S.A., the division compounds TPEs at eight locations in the U.S., Europe, and Asia and is an international supplier to the appliance, automotive, construction, medical-device, wire and cable, and other consumer and industrial product industries. Other plastics businesses of Teknor Apex include the Bioplastics, Nylon, Specialty Compounding, and Vinyl Divisions and Teknor Color Company. Visit www.teknorapex.com.
Robert J. Martino
Martino Communications Inc.
8 Main Street / P.O. Box 379
Hastings-on-Hudson, NY 10706 U.S.A.