Compounds win ISO certification
A
VTC TPE Group product story
Edited by the Engineeringtalk editorial team
Mar 23, 2007
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.
VTC Elastoteknik, the Swedish production facility of the VTC TPE Group, British Vita's Thermoplastic Elastomer (TPE) Compounding Group has been awarded ISO13485:2003 accreditation for the development, manufacture, marketing and sales of thermoplastic elastomer compounds for the medical device industry.
The accreditation, approved by Intertek, follows the Eur 3.7 million 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 offers representative grades that have passed USP Class VI as well as cytotoxicity tests.
ISO13485:2003 is a complement to the ISO9001 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 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".
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.
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