DuPont Engineering Design Electronic Magazine
for health care components
By John Gavenonis
Global Health Care Manager – DuPont Performance Polymers
With the recent introduction of several new grades of DuPont engineering polymers that are specially designed to meet demanding health care requirements for use – and the scheduled launch of a further two during 2010 – the company is actively pursuing its objective to become the material supplier of choice to the health care segment.
Utilizing the company’s expertise and long experience in polymer science, quality and application development, DuPont offers one of the broadest portfolios of specialty engineering plastics and thermoplastic elastomers for the global medical products market. Dedicated health care application development teams in North America and Europe provide customers with the material advice and technical support required to gain the highest performance from these materials.
Examples of specialty products for the health care sector include DuPont™ Delrin® acetal resins. With key properties such as high strength, stiffness and toughness, Delrin® has the most metal-like behavior of any unreinforced plastic, and enables the cost-effective production of components with the maximum reliability and safety. Alternatively, there is the flexibility of DuPont™ Hytrel® TPC-ET – a plasticizer-free, PVC-free and BPA-free thermoplastic polyester elastomer available in a range of durometers from Shore 30D to Shore 82D. Retaining its flexibility and mechanical properties over a wide valves, seals, springs, shock absorbers, tubing and noise management parts.
Further health care-related benefits of the semi-crystalline polymers available from DuPont include their high resistance to many of the chemicals used for analysis, cleaning and disinfection, their barrier properties to prevent water transmission or oxygen permeation, and their excellent performance in a number of sterilization processes – making them ideal materials for a variety of single-use and multiple use medical and surgical devices. In particular, the ability to use DuPont polymers to form geometrically complicated parts with fewer steps through rapid production cycles extend the availability of less expensive, single-use medical devices to new markets including the developing world.
‘Special’ and ‘Premium Control’ grades
The DuPont Performance Polymers health care product offering provides food agency compliance (FDA and EFSA) as well as USP Class VI and ISO 10993-5 and -11 compliance. They are available in two versions, each reflecting different levels of manufacturing control and material testing. Fifteen 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. Thirteen of the grades are available in ’Premium Control’ versions meeting requirements for even-more demanding manufacturing controls, broader regulatory support, additional testing, DMF access and the highest level of inspection. Both ’Premium Control’ and ‘Special Control’ grades are produced according to good manufacturing practice (GMP) guidelines.
A prime example of the use of DuPont plastic to address a pertinent health care challenge is provided by the recently launched Bardo™ Airway – a patent-pending, combined bite block and airway from a company of the same name based in California, US. With dental and oral injuries found to occur in approximately 18 percent of cases of surgery and anesthesia, the Bardo Airway, manufactured from a Special Control grade of Hytrel®, minimizes dental injury by shifting jaw clenching forces from the weaker incisors to the stronger molars while lifting the tongue from the posterior pharynx to provide an open airway. The product is molded using Hytrel® because of the material’s unique combination of the strength required to protect from bite forces and the flex modulus necessary to displace the tongue and open the airway. It is also compliant with the required regulations for the application and addresses environmental health concerns with its plasticizer-free/BPA-free formulation.
The Bardo™ Airway is a trademark of InfoHealthNetwork, Inc.
For more information on DuPont Polymers in medical device applications, visit the Medical Device website.