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Dupont is to exhibit specific grades of engineering polymers that are suitable for use in medical equipment at Medtec Europe 2011, which is due to take place in Stuttgart on 22-24 March 2011.

These grades are intended to support healthcare companies that lead medical progress through new and innovative devices.

For example, a Special Control (SC) grade of Dupont Zytel nylon has recently been used for components of an accurate 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 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 the International Cartilage Repair Society in October 2010, is marketed as a procedure pack, with the collagen implant preloaded in an 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.

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 for the precise flexibility of the compressor fingers.

Suhaib Hassan, product manager at Tigenix, said: ‘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.

‘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,’ added Hassan.

Dupont offers a selection of engineering plastics and thermoplastic elastomers for medical devices, surgical devices and diagnostic or pharmaceutical manufacturing equipment.

The company’s healthcare product offering provides food agency compliance (EMSA and FDA), ISO 10993-5 and -11 compliance and USP Class VI compliance.

Speciality healthcare products are manufactured following Good Manufacturing Practice (GMP) guidelines.

The healthcare 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 SC grades that meet the high standards of manufacturing consistency important for a range of non-implantable medical products.

Twelve of the grades are available in Premium Control (PC) versions, meeting the requirements for even more demanding manufacturing controls, broader regulatory support, more testing, DMF access and a high level of inspection.

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