Clariant, a world leader in specialty chemicals today announced that its Healthcare Packaging manufacturing facility in Dongguan, Guangdong Province, China, recently obtained ISO 15378:2011 certification for production of desiccant packets for healthcare applications.
“Expanding our ISO 15378 certification to our global sites is of paramount importance, as it demonstrates our focus on patient safety and current Good Manufacturing Practices.” said Frédéric Gaire, Head of Quality, Clariant Healthcare Packaging. “Given the high level of respect this ISO certification has in the pharmaceutical and nutraceutical industries, customers can be confident of Clariant’s commitment to quality on a global basis.”
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. Packets are available in DuPont Tyvek® and as Continu-Strip® that feature a hole in every seal to optimize the desiccant insertion process. Sizes available range from 0.25g to 10g.
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. Also integral for BCP, the new plant in Cuddalore will supply the large and growing Indian market and once online will quickly begin the process of ISO 15378 certification.