Polymers guarantee compliance
Dean Palmer talks to a global supplier of engineering polymers, which has just launched an initiative targeted at manufacturers of medical devices
At the recent medical and healthcare exhibition 'Medica 2005', global engineering polymer supplier DuPont unveiled its new initiative aimed at manufacturers of non-implantable medical devices, drug delivery systems and surgical instruments. The initiative is due to be unveiled here in the UK at the Medical Device Technology show at the NEC in February 2006.
Ernst Poppe, European healthcare marketing manager at DuPont Engineering Polymers told Eureka: "We are launching a specific range of polymers targeted at medical device manufacturers which will guarantee regulatory compliance, including the stringent controls required in the compounding, recipe consistency, reliability of manufacture and supply of polymers. Customers are already using our industrial grade polymers in medical devices but there is increasing pressure in the medical industry to comply with strict regulations."
DuPont is testing and developing a wide range of engineering plastics and elastomers that can meet varying levels of manufacturing control required for healthcare components or products. The company will provide assistance to customers in material selection, tool design, moulding optimisation and documentation of compliance of materials and manufacturing controls with regulatory or customer requirements. The new grades have undergone strict biocompatibility and physical-chemical tests. Poppe cited Delrin SC (strict control) and Delrin PC (premium control) as two of these new grades, specifically developed for the medical industry.
The initiative is more about regulatory compliance than completely new grades of polymer. Poppe explained that supply chain management was key. He said that DuPont would be involved with sole supplier sourcing and the careful selection of polymer resin production sites around the world. "For the medical industry, we're being very careful and selecting products where we are an integrated supplier. In other words, we control all the value-adding steps in the supply chain. Many compounders, for example, cannot switch production straight from the automotive industry to supplying the healthcare industry."
The initiative covers non-implantable medical devices; drug delivery systems; analytical and diagnostic equipment components, such as valves, pumps or housings; surgical instruments; and material handling components for pharmaceutical production.
DuPont has around 25 customers in the medical industry. One of these, SHL Medical, specialises in the design and manufacture of self-injection devices, which are customised for pharmaceutical and biotech companies.
These auto-injection devices work with the modern drug delivery concept of pre-filled syringes. The advantage here is that they satisfy the global medical need for safe, convenient, cost-effective drug delivery options.
At the core of the design are two of DuPont's polymers, Delrin and Zytel. Roger Samuelsson, founder and president at SHL commented: "It is of paramount importance for high-end delivery devices that the mechanical function of the device operates within a very narrow tolerance. When a device is expected to deliver a medicine with a value of up to US$ 2,000 per shot, the room for error or non-conformance is zero."
SHL's general manager Frank Isaksson pointed out some of the main requirements of the polymers: "High tensile strength, impact resistance and stiffness are important. Also, excellent dimensional stability in combination with resistance to creep and a certain level of natural lubricity is often needed. Delrin acetal resins can fulfil these requirements. When there is a need for even more reduced friction, specially-tailored lubricated grades of Delrin are used."
Samuelsson suggested other reasons why SHL was using DuPont's polymers: "SHL values the excellent and responsive technical support from DuPont. Regional DuPont specialists frequently visit SHL's facilities in Taiwan and China, providing technical training and support to overcome potential challenges with innovative mechanical component design, and with material selection. This type of hands-on, value-added service on the ground is one of the primary reasons SHL enjoys working with DuPont."
