Tekni-Plex, Inc. has been granted ISO 15378 certification for its recently opened Tekni-Films pharmaceutical films manufacturing facility in Holland, Ohio. 

“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.  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,” said Garrett Hager, director, pharma films & medical packaging, Americas.

ISO 15378 specifies requirements for a quality management system. 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.

Driven by customer requirements, an extensive quality management system was put in place to validate the high-quality standards shared by Tekni-Plex and pharmaceutical manufacturers. Hager explains that the certification not only demonstrates a quality commitment to customers but also provides formal methodology for continuous business improvement.

“We are pleased to be able to provide our customers with ISO certification within four months of commissioning the facility,” Hager said.