Clariant, a world leader in specialty chemicals, has announced that its Healthcare Packaging manufacturing facility in Belen, New Mexico, has achieved ISO 15378:2011 certification for products manufactured for healthcare applications, including desiccant canisters and packets and other container-closure systems.
The Belen plant is the second Clariant site – the first in the United States – to meet the ISO 15378:2011 standards, following only the Clariant manufacturing facility in Romorantin, France.
ISO 15378:2011 specifies requirements for Good Manufacturing Practices (GMP) and a quality management system (QMS) for manufacturers of primary packaging materials for pharmaceuticals. The standard documents states:
"The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product because of their direct product contact."
Organizations 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, illustrated the certification's importance: "Clariant has made a concerted commitment to serve the pharmaceutical and healthcare packaging sector with the highest level of quality. Achieving ISO 15378 certification is a milestone for Clariant and our customers, as it recognizes our conformity to the GMPs that are essential for serving a highly demanding and regulated industry."
Clariant Healthcare Packaging manufactures a full range of controlled atmosphere packaging solutions, including pharmaceutical desiccants, equilibrium sorbents, adsorbent polymers, oxygen scavengers and pharmaceutical closures and containers. Using both active and passive packaging technologies, the unit offers an array of standard components and complete systems, as well as full innovation and development capabilities. 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-molding department.
"ISO 15378 is well respected by our customer base—which includes many major multi-national pharmaceutical companies," said Frederic Gaire, Global Quality Manager for Clariant Healthcare Packaging, "and it continues to steadily increase in importance. The standard both supports and complements rigorous and regular customer audits."