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New grades of polymers that meet demanding requirements for use in non-implantable healthcare products

Du Pont Engineering Polymers : 10 September, 2006  (New Product)
Twelve grades of DuPont engineering polymers that meet demanding requirements for use in non-implantable healthcare products and equipment are making their debut at the MD&M West exposition in Anaheim, Calif.
The materials are among the first commercial offerings to emerge from a recently launched DuPont initiative to develop and market a broad portfolio of engineering plastics and elastomers for non-implantable medical devices and for diagnostic or pharmaceutical manufacturing equipment. The initiative utilizes the company’s expertise and long experience in polymer science, quality, safety and regulatory compliance for the medical products market.

Nine of the materials are grades of DuPont Hytrel thermoplastic polyester elastomer. “DuPont Hytrel 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 Cynthia Crouch, global healthcare initiative manager for DuPont Engineering Polymers. Potential uses include soft-touch/grip surfaces, valves, seals, springs, shock absorbers, tubing and noise management parts, to name only 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 gamma-ray sterilization and is fully colorable.

The Hytrel grades developed for healthcare products range from flexible to rigid: Shore D hardness ranges from 40 to 82. All retain the performance, design and cost benefits that Hytrel has demonstrated in other industrial and consumer products. Hytrel exhibits excellent resistance to flex fatigue, flex-cut growth, tearing, abrasion and creep, and it has good strength and toughness over a broad temperature range.

DuPont Engineering Polymers is also introducing three additional grades of engineering plastics for non-implantable medical devices. These are: a Delrin polyacetal with very low volatile emissions; a Zytel nylon with low moisture absorption; and a Zenite liquid crystal polymer resin providing extremely good barrier properties and chemical inertness. The Zenite grade is particularly suitable for applications requiring protection of pharmaceuticals against oxygen and water vapor exposure.

All of the grades for medical products either have already been or are currently being tested according to certain of the ISO 10993-1 and USP Class VI test criteria. Many grades also comply with U.S. Food and Drug Administration and/or European Union requirements for contact with specific kinds of foods under defined conditions. Consult with DuPont for details on testing for specific grades and for food contact compliance statements.

Most of the new grades are available in two versions, each reflecting different levels of manufacturing control, material testing and regulatory support. Customers chose the version that meets the needs of their specific application. All are available as “special control” grades that meet very high standards of manufacturing consistency important for a wide range of non-implantable medical products. Ten of the grades are available in “premium control” versions meeting requirements for even more demanding manufacturing controls, broader regulatory support, more tests, periodic testing 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).

The DuPont Engineering Polymers business supports customers with assistance in material selection, tool design and molding optimization. The business unit is also developing and testing additional materials from its broad portfolio of engineering polymers.

“Our healthcare initiative brings to healthcare product manufacturers the benefits of DuPont expertise in science, technology, quality and safety in manufacturing, regulatory compliance and other areas,” said Cynthia Crouch. “We have a broad polymer portfolio that can meet a wide range of application needs, global manufacturing and supply strength and long experience in delivering expert assistance to molders,” she added. “Our objective is to become a material supplier of choice to the healthcare segment for pharmaceutical and non-implantable medical devices.”

More information about the use of DuPont engineering polymers in healthcare applications can be found on the web at or by contacting your DuPont representative.
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