Tekni-Plex ISO 15378:2007 Certification
November 1, 2012
News
November 1, 2012 - TekniPlex Europe NV has successfully obtained ISO 15378:2007 certification, which permits the company’s Belgium facility to design, develop, manufacture and sell packaging materials dedicated for the pharmaceutical and medical industry.
To receive this certification, companies must demonstrate the implementation and maintenance of a Quality Management System for primary packaging materials for medicinal products, as well as meet certain requirements for the application of ISO 9001:2000 in terms of Good Manufacturing Practices (GMP).
The scope of the certificate includes extrusion of tubing and film, lamination and slitting of films for medical and pharmaceutical packaging applications. “Auditors are always particularly impressed by the fact that all tubing and film production is made in Cleanroom; validated to ISO14644” says Steven Lemants, Manager of Quality & Procurement at Tekni-Plex Europe N.V.