Twelve new grades of DuPont engineering polymers that meet demanding requirements for use in health care products and equipment are making their debut. The materials are being introduced in addition to existing products making the DuPont offering one of the broadest portfolios of engineering plastics and thermoplastic elastomers for medical devices, surgical devices and for diagnostic or pharmaceutical manufacturing equipment. These products utilize the company's expertise and long experience in polymer science, quality, safety and regulatory compliance for the global medical products market.
The DuPont portfolio consists of numerous products including DuPont Hytrel TPC-ET, Delrin POM, Zytel nylon, Crastin PBT and Zenite LCP. DuPont health care products offer benefits including structural properties with lower material density and ease of forming geometrically complicated parts. In addition, minimal finishing operations, rapid production cycles, and longer life with enhanced durability all contribute to cost savings. "DuPont Hytrel thermoplastic polyester elastomer is a versatile engineering material with potentially significant advantages in performance and part costs over alternative flexible materials, including plasticized PVC, conventional rubbers and several other TPEs (thermoplastic elastomers)," said John Gavenonis, global health care manager - DuPont Performance Polymers. Potential uses include soft-touch/grip surfaces, valves, seals, springs, shock absorbers, tubing and noise management parts, to name a few applications in a wide range of medical products and pharmaceutical equipment.
Hytrel has several highly valued attributes for medical and pharmaceutical applications. Unlike flexible PVC, it contains no plasticizers. Hytrel also provides more resistance to disinfectants and other aggressive chemicals and elevated temperatures than some alternative TPEs. In addition, it is well-suited for sterilization processes and is fully colorable.
The DuPont Performance Polymers health care product offering provides food agency compliance (FDA and EMSA), USP Class VI compliance as well as ISO 10993-5 and -11 compliance. Speciality health care products are manufactured following GMP. All products are available globally.
The specialty health care grades with regulatory support are available in two versions, each reflecting different levels of manufacturing control and material testing. Customers work with DuPont to identify the version that meets the needs of their specific application. 16 of the products are available as "special control" grades that meet very high standards of manufacturing consistency important for a wide range of non-implantable medical products. Twelve of the grades are available in "premium control" versions meeting requirements for even more demanding manufacturing controls, broader regulatory support, more testing, DMF access and the highest level of inspection.
All of the materials are well-suited for the design of cost-saving multi-functional components that can replace two or more parts made of other materials. They can be economically processed into finished parts by injection molding, extrusion (tubing, profiles or film) and blow molding. These materials are not intended for and should not be used for parts permanently implanted within the human body (i.e., implants of 30 days or more duration). DuPont Performance Polymers support customers with assistance in material selection, tool design and molding optimization. The business unit is also developing additional health care specialty products from its broad portfolio of engineering polymers.