Clariant Healthcare Packaging has announced that its healthcare packaging manufacturing facility in Belen, New Mexico obtained ISO 15378:2011 certification for healthcare applications
Clariant’s Effervescent & Diagnostic Test Strip Packaging
ISO 15378:2011 specifies requirements for Good Manufacturing Practices (GMP) and a quality management system (QMS) for manufacturers of primary packaging materials for pharmaceuticals.
Organisations certified under the standard must demonstrate their ability to consistently meet customer requirements, including compliance with the specific regulations that apply to packaging materials used in pharmaceutical applications.
Andy Walti, head of Clariant Healthcare Packaging, said: “Achieving ISO 15378 certification is a milestone for Clariant and our customers, as it recognises our conformity to the GMPs that are essential for serving a highly demanding and regulated industry.”
The ISO 15378:2011 certification covers the site’s desiccant production value streams, including its high-speed canister assembly department, its desiccant packet form-fill-seal department and its injection-moulding department.
Frédéric Gaire, global quality manager for Clariant Healthcare Packaging, said: “ISO 15378 is well respected by our customer base—which includes many major multi-national pharmaceutical companies and it continues to steadily increase in importance. “
The Belen plant is the second Clariant site to meet the ISO 15378:2011 standards, and the Clariant manufacturing facility in Romorantin, France, was the first to be certified.