ISO 15378:2015 certification is for its pharmaceutical film production facility in Tradate, Italy
Tekni-Plex Gallazzi has been granted ISO 15378:2015 certification for its Tradate (VA), Italy manufacturing facility, which is part of the Tekni-Films business unit.
Tekni-Films is a supplier of thermoformable blister barrier films, flexible films, lidding foils and pouch materials for pharmaceutical, medical, diagnostic health and personal care products.
The Tradate plant produces polyvinyl chloride films and polyvinylidene chloride-coated barrier films for a variety of packaging applications including pharmaceuticals.
“Tekni-Plex Gallazzi has made a series of large investments in the Tradate facility to support continuous improvement in product quality and production efficiency for our pharmaceutical blister films,” said Antonino Crisafulli, Managing Director.
“Receiving the ISO15378 certification is a third party confirmation that our processes meet the pharmaceutical industry’s latest quality and Good Manufacturing Practice (GMP) requirements.”
To be granted ISO 15378:2015 certification, an organisation needs to demonstrate its ability to consistently apply GMP principles in the development and production of primary packaging materials for pharmaceutical products.