Local Clariant Healthcare Packaging Facility Earns ISO 15378:2011 Certification

CHARLOTTE, N.C., Oct. 8, 2015 /PRNewswire/ -- 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."

www.clariant.com/healthpack

Clariant Healthcare Packaging is dedicated to enhancing and protecting healthcare products by providing a full portfolio of controlled atmosphere packaging solutions that protect products from degradation and help maintain stability and integrity throughout shelf life. With a global production network and innovative product development, its products include desiccants, oxygen scavengers, active container-closure systems and multilayer barrier packaging.

For More Information:

www.clariant.com

Clariant is a globally leading specialty chemicals company, based in Muttenz near Basel/Switzerland. On December 31, 2014 the company employed a total workforce of 17 003. In the financial year 2014, Clariant recorded sales of CHF 6.116 billion for its continuing businesses. The company reports in four business areas: Care Chemicals, Catalysis & Energy, Natural Resources, and Plastics & Coatings. Clariant's corporate strategy is based on five pillars: increase profitability, reposition portfolio, add value with sustainability, foster innovation and R&D, and intensify growth.

SOURCE Clariant

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