Tekni-Plex Inc. has received ISO 15378 certification for its recently opened Tekni-Films pharmaceutical films manufacturing facility in Holland, Ohio.
To obtain the certification, an organization needs to demonstrate its ability to provide primary packaging materials for pharmaceutical products that consistently meet customer requirements, including regulations and other international standards applicable to primary packaging materials.
“With an increasing number of pharmaceutical companies requiring ISO certification from their suppliers, we built our new Holland, Ohio manufacturing facility focused on those requirements," says Garrett Hager, director of pharma films and medical packaging, Americas. " We not only wanted to obtain ISO certification, but we wanted to go after the more stringent ISO 15378 certification. This shows our commitment to quality management and separates us from manufacturers with lower-level certifications."
Driven by customer requirements, a quality management system was put in place to validate the high-quality standards shared by Tekni-Plex and pharmaceutical manufacturers.