In collaboration with O'Sullivan Films, Winchester, VA, USA and Genesis Plastics Welding, IN, USA, Teknor Apex has demonstrated that films produced from its Medalist MD-500 series eliminate the traditional disadvantages of TPEs in such applications as fluid drainage and storage bags, cushioning bladders, and surgical pouches, exhibiting performance that is fully comparable to PVC in processing, bonding, assembly, and clinical handling. "Our company has attempted to calender a wide range of plastics besides PVC and concluded that most are simply not calenderable, noted Chuck Stronach, O'Sullivan Films commercial manager for healthcare products. "We were intrigued to discover that Medalist 500 Series compounds can be adapted for this process, and together with Teknor Apex we carried out a lot of R&D work to optimize the production and properties of Medalist calendered films. Film and bag applications for Medalist MD-500 Series TPEs include cushioning bladders (for mattresses, wheel chairs, and gurneys); IV and saline bags; medicine storage and delivery pouches; bags for enteral and parenteral nutrition storage and delivery; dialysis bags; and surgical pouches.[image_0] "While there is pressure on medical device companies to replace PVC in a number of applications, the track record and excellent cost-performance profile of PVC have in the past made it difficult to replace, said Teknor Apex's Elliott Pritikin. "Recently, however, Medalist MD-500 Series elastomers have been commercially successful as alternatives to PVC in medical tubing, and now they are proving to offer clear-cut advantages over PVC in film products. The TPE has two main advantages: Less material. - Film made from Medalist MD-500 Series TPEs exhibits the same degree of strength as PVC film that is twice as thick. Less weight. - Because the TPE compounds are 30% less dense than flexible PVC and can be down-gauged without compromising strength, finished products can be 66 to 70% lighter. In addition, Medalist elastomers are available at lower hardness ranges than flexible PVC, provide a broader processing window, exhibit greater elasticity and tear strength, have superior flexibility and impact strength at low temperatures, are less permeable to nitrogen and moisture, and have a wider range of service temperatures. These TPEs exhibit 25% less color change upon exposure to gamma irradiation than standard (i.e., not gamma-stable) grades of flexible PVC.About O'Sullivan Films and Genesis Plastics Welding
One key partner of Teknor Apex is O'Sullivan Films, Inc., whose healthcare products include both PVC and TPE. The company's PVC products are manufactured by calendering. This process produces film by fusing compound in a mixer and then passing the material through a series of synchronized nip rolls. In its ISO 13485-certified operation for medical films, O'Sullivan Films has calendered Medalist MD-500 Series compounds into films with widths up to 193 cm, using special vision monitoring systems for quality control and a dedicated "healthcare slitter capable of producing widths down to 25 mm. Teknor Apex also collaborated with Genesis Plastics Welding, an ISO 13485:2003 certified medical device contract manufacturer. Genesis' proprietary radio frequency (RF) welding technology, ecoGenesis, enables sealing of polar and non-polar plastics, including film produced from a Medalist elastomer. While the alternative technique of heat sealing produces only a straight-line bond, RF welding with ecoGenesis makes it possible to form strong permanent bonds in complex geometric patterns; including sealing two mono-layered film to tubing producing traditional infusion bags.