The broad DuPont offering for the medical and pharmaceutical industries – from materials for the production of medical components to practical advice on conformity with the latest medical device packaging legislation – will once more be in evidence at MDT 07 in Birmingham, UK (14th – 15th February). The company’s exhibit at stand E206 will centre on the ability of DuPont™ Teflon® fluoropolymer resins and coatings to provide near universal chemical resistance and high levels of purity for medical and pharmaceutical systems; its portfolio of engineering plastics and elastomers to meet varying levels of manufacturing control required for healthcare components or products; and the compliance of DuPont™ Tyvek® to the new ISO standards for medical packaging.
DuPont™ Teflon® facilitates the UV inactivation of viruses in pharmaceutical products
The ability of DuPont™ Teflon® fluouropolymers to meet needs for product purity, cleanability, durability and low maintenance costs is illustrated by the patented UVivatec® from Bayer Technology Services GmbH. The novel system for the safe inactivation of dangerous viruses in pharmaceutical products, using UV irradiation, consists of a helical wound tubing of Teflon® coiled round a quartz glass tube containing a UV lamp. The product to be disinfected passes through the coiled channel and around the UV lamp in a helical motion, facilitating its even and effective radiation in a short enough time to avoid the risk of damaging the active substances within the product. Due to the comparative cost and fragility of quartz glass for the helical wound tubing, Teflon® was chosen for its manufacture on the basis of the Teflon® PTFE’s chemical inertness and purity. The resulting construction with inert materials is very stable, and because of the low cost the module is disposable, thus avoiding expensive cleaning.
Engineering thermoplastics for medical components
Supporting manufacturers of pharmaceuticals and non-implantable medical devices in capturing the performance and cost benefits of its engineering thermoplastics, the DuPont offering includes special control and premium control grades for the healthcare industry which meet the levels of manufacturing control required for healthcare products. Moreover the company provides assistance to customers in polymer selection, tool design, moulding optimization and documentation of compliance of materials and manufacturing controls with regulatory or customer requirements.
In a recent example of the benefits to be gained by designing medical applications with engineering polymers from DuPont, five injection-moulded parts of unreinforced DuPont™ Delrin® acetal have been incorporated in a bone cement mixer from Italian company Bidoia. According to the company, without the unreinforced DuPont™ Delrin® acetal, the parts, including the mixing blades and rotary piston, would have been more difficult or more costly to produce. Bidoia also attributes the smooth, efficient operation of the bone cement mixer to the low-friction acetal resin.
DuPont Tyvek® assists compliance with new ISO standards for medical packaging
DuPont Medical Packaging will use MDT 07 to inform visitors of the current status with regards to the harmonisation of medical packaging standards, and its implications for the medical device industry, particularly in Europe. To date there have been two major medical packaging standards relating to the packaging of terminally sterilized medical devices such as peelable pouches or lidded trays: EN 868 for Europe and ISO 11607 for the rest of the world. As a result, those involved in the design and manufacture of medical packaging on a global basis have had to refer between the two documents.
As part of the harmonization process, EN 868-1 has been replaced by the new ISO 11607 standards that were published in April 2006 and are now mandatory in Europe. These detail the requirements needed to comply with the Medical Device Directive. The ISO 11607 standards are split into two parts to cover the areas of materials and design (part 1) and processes (part 2). It is part 2 that is of greatest significance to Europe – the previous EN 868-1 standard did not cover the requirements for forming, sealing and assembly processes of sterile packaging, hence it represents a new validation stage for all those involved in the forming, sealing and assembly of terminally sterilized packaging in Europe.
As the producer of Tyvek® product for medical packaging, DuPont Medical Packaging Systems has compiled documentation which demonstrates the compliance of Tyvek® with the materials portion of the ISO 11607 Standard. This will allow the medical device manufacturers and sterile packaging producers to focus on the package production and final package validation portions of the standard. Evidence of the compliance of Tyvek® to the new ISO standards reflect the excellent product characteristics of Tyvek® including, strength, microbial barrier, moisture resistance, inertness to most chemicals, air permeability, clean peeling seals etc, which combine to enable the high-value, terminally sterilized packaging of medical devices, which can be sterilized by a wide variety of sterilization methods.
DuPont is a science-based products and services company. Founded in 1802, DuPont puts science to work by creating sustainable solutions essential to a better, safer, healthier life for people everywhere. Operating in more than 70 countries, DuPont offers a wide range of innovative products and services for markets including agriculture and food; building and construction; communications; and transportation.
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UVivatec® is a registered trademark of Bayer Technology Services GmbH
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Photo: Bayer Technology Services GmbH
UVivatec® UV virus inactivation from Bayer Technology Services GmbH provides an innovative solution for viral safety in pharmaceutical processes. Its principle components are a coiled tube made of DuPont™ Teflon® fluoropolymer, which is wound around a UV lamp encapsulated within a plate glass tube (left of picture). Its design facilitates the even and effective radiation of pharmaceutical products in a short enough time to avoid the risk of damaging the active substances contained within them.