Specific grades of DuPont engineering polymers that meet demanding requirements for use in medical equipment form the focal point of the company's exhibit on stand 4538 at Medtec Europe 2011 in Stuttgart (22 - 24 March 2011). The availability of these specialty health care grades broadens the choice of high performance polymers with healthcare specific manufacturing control and regulatory support.
These grades are intended to support healthcare companies which lead medical progress through new and innovative devices. This is most recently reflected by the adoption of a Special Control (SC) grade of DuPont Zytel nylon for components of an accurate and easy-to-use collagen implant delivery device. The functional performance of the DuPont material and its regulatory compliance are key factors in its specification.
The ChondroMimetic from TiGenix NV (Leuven, Belgium) is a CE-marked collagen based implant for the treatment of small osteochondral (cartilage and underlying bone) defects. The implant supports the body's natural repair mechanisms to encourage the simultaneous repair of both articular cartilage and the bone to which it is attached. The product, which was officially launched in Europe during the 9th World Congress of International Cartilage Repair Society in October 2010, is marketed as a procedure pack with the collagen implant preloaded in an accurate, easy-to-use arthroscopic delivery device.
The device consists of several polymer components, including a white outer-casing made from ABS and a translucent polycarbonate delivery tube at its tip, which allows visual progress of the implant delivery to be maintained during the surgical procedure. Significantly, the two components made from Zytel SC - the plunger and compressor fingers - come into direct contact with the implant and are key to holding it in place and inserting it smoothly and accurately into the defect site. The DuPont material was specifically chosen for the stiffness and low-friction behaviour of the plunger as well as providing the precise flexibility of the compressor fingers.
"We specified a Special Control grade of Zytel nylon based on the advice that the material comes with the required level of manufacturing control, testing and regulatory support for use in our delivery device," explains Suhaib Hassan, product manager at TiGenix. "For instance the device is required to meet the requirements of ISO 10993, which includes testing to support the storage of the implant in contact with the plastic parts of the delivery device for its entire shelf life."
DuPont: the material supplier of choice to the health care segment
DuPont offers one of the broadest portfolios of engineering plastics and thermoplastic elastomers for medical devices, surgical devices and for diagnostic or pharmaceutical manufacturing equipment. The DuPont health care product offering provides food agency compliance (EMSA and FDA), ISO 10993-5 and -11 compliance as well as USP Class VI compliance. Speciality health care products are manufactured following GMP.
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. Sixteen 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.