Clariant Achieves ISO 15378 for its Facility in China
The Healthcare Packaging manufacturing facility in Dongguan, Guangdong Province, China, from Clariant, Muttenz, Switzerland, recently obtained ISO 15378:2011 certification for the production of desiccant packets for healthcare applications.
ISO 15378:2011 specifies requirements for current Good Manufacturing Practices (cGMP) and a quality management system (QMS) for manufacturers of primary packaging materials for pharmaceuticals. Organizations certified under the standard must demonstrate their ability to consistently meet customer requirements, including compliance with the specific regulations and standards that apply to packaging materials used in pharmaceutical applications. The ISO documents state: “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.”
Clariant produces its desiccant packet brands Sorb-it (silica gel) and Tri-Sorb (molecular sieve) at numerous facilities globally, including in Dongguan, providing customers a wide array of options and Business Continuity Planning (BCP). The Dongguan site produces a full portfolio of desiccant packets both for regional Asia-Pacific healthcare markets and for export to the Americas and Europe.
Dongguan follows Clariant’s other sites that already maintain ISO 15378:2011 certification: Romorantin, France; Belen, NM/USA; and Changshu, China. The network of production sites will soon include a fifth facility in Cuddalore, India, where Clariant is constructing a new plant.
Clariant International Ltd.
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