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2007-03-24 News Release

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Thermoplastics Group Awarded Medical Accreditation

Plant investments for the production of a range of Thermoplastics by VTC TPE Group represent good progress for market share in the medical device market.

The Swedish production facility of the VTC TPE Group, British Vita’s Thermoplastic Elastomer (TPE) Compounding Group, VTC Elastoteknik, has been awarded ISO 13485:2003 accreditation for the development, manufacture, marketing and sales of Thermoplastic Elastomer compounds for the medical device industry.

Find Information and Suppliers of thermoplastic elastomer compounds.

The accreditation, approved by Intertek, follows the 3.7 million euro investment in a fourth production line at the site in 2006 and represents an important step in the group’s strategy to grow market share in the medical device market. The group’s Mediprene* range of TPE materials offer representative grades that have passed USP Class VI as well as cytotoxicity tests according to USP <87>/ISO 10993-5.

VTC Elastoteknik achieves ISO 13485:2003 accreditation for the medical device industry. Click Go for High resolution image. photo: VTC TPE Grp

ISO 13485:2003 is a complement to the ISO 9001 standard while adding additional requirements specifically related to medical devices. Greater emphasis is placed on the use of procedures to regulate and control how activities and processes should be performed. Above all these procedures need to be maintained and once established cannot be changed.

“This award is the result of a 14 month programme to improve quality management and systems throughout the Swedish site,” commented Mr. Per G. Hellberg, Managing Director of the VTC TPE Group, “by adopting the same procedures throughout our TPE offering and not just our medical range we demonstrate our commitment to supply quality products with consistently predictable processing characteristics as well as ongoing batch to batch consistency.”

Typical medical device applications by the VTC TPE Group include inhalers, drip chambers, drainage bags and tubing, drug packaging, medication dispensers and drainage valves. Click Go for High resolution image. photo: VTC TPE Grp

The VTC TPE Group is dedicated exclusively to supporting the Thermoplastic Elastomer (TPE) user market. The group supports OEMs, moulders and designers at all stages of product development in the medical, electronic, automotive, construction and sports & leisure industry.

The development of the Mediprene TPE compound family has given the Group a strong presence in the European medical device market. Mediprene TPE grades not only meet customer demands for being PVC-free, but are also completely synthetic and thus latex free, avoiding potential allergy risks. Furthermore all Mediprene TPE compounds can be sterilised by established techniques in the medical industry.

*Mediprene is a registered trademark, the property of The British Vita Group of companies. VTC TPE compounds were among the first to be manufactured in Europe and today, embracing TPS, TPOs and TPVs, the group’s portfolio of TPEs is one of the widest in the marketplace.

Find information about VTC TPE Group.

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