Switzerland-headquartered Clariant has secured ISO 15378:2011 certification for its new healthcare packaging manufacturing facility in Dongguan, China.
The certification has enabled the facility to produce desiccant packets for healthcare applications.
It specifies requirements for current good manufacturing practices (cGMP) and a quality management system (QMS) for primary packaging material manufacturers engaged in the pharmaceuticals sector.
Organisations certified under the standard are required to demonstrate their ability to consistently meet customer needs, including compliance with standards that apply to packaging materials used in pharmaceutical applications.
The Dongguan site is Clariant’s fourth site to achieve ISO 15378 certification after Romorantin, France; Belen, New Mexico, US; and Changshu, China.
Clariant healthcare packaging quality head Frédéric Gaire said: “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.
“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.”
Clariant currently manufactures its desiccant packet brands, Sorb-it (silica gel) and Tri-Sorb (molecular sieve), at the Dongguan site for the Asia-Pacific, Americas and European healthcare markets.
The company is currently building a new desiccant packet manufacturing facility in Cuddalore, India.