Clariant is a global leader in specialty chemicals. Recently, it announced that its healthcare packaging facility in Belen (New Mexico) has received ISO 15378:2011 certification. The Belen facility is Clariant’s second site to get this certification. The one in Romorantin, France was the first Clariant site to receive this certification.
The site at Belen obtained its certification for manufacturing products meant for healthcare applications. This includes desiccant packets and canisters as well as other container-closure structures.
ISO 15378:2011 defines standard requirements for a Quality Management System and Good Manufacturing Practices (GMP) for producers of primary packaging components meant for pharmaceuticals.
In an organization, understanding the GMP concepts in control and production of primary packaging materials is extremely important to ensure patients’ safety. This is because while using the medicinal products, patients come in direct contact with them.
Clariant’s Commitment to the Healthcare Packaging Industry
Companies certified under this ISO standard must exhibit their ability to regularly meet customer needs. It also includes compliance with certain directives applicable for packaging components used in pharmaceuticals practices.
According to Andy Walti, leader of Clariant Healthcare Packaging, the company has made a commitment to serve the healthcare packaging and pharmaceutical sector with the optimum quality level. He added that getting the ISO 15378 certification is a milestone for Clariant as it acknowledges their compliance to the GMPs, which is critical for serving an extremely challenging and regulated sector.
Clariant Healthcare Packaging produces a complete range of controlled atmosphere packaging solutions. These include equilibrium sorbents, pharmaceutical desiccants, oxygen scavengers, adsorbent polymers, apart from pharmaceutical containers and closures. Both passive and active packaging technologies are employed to enable the unit offer a wide variety of complete systems and standard modules, as well as 100% development and innovation capabilities.
The desiccant production value streams of the site are covered by the ISO 15378:2011 certification. This includes its injection-moulding branch, its canister assembly department boasting of a high speed, and its desiccant packet form-fill-seal division.
According to Frédéric Gaire, Clariant Healthcare Packaging’s Global Quality Manager, the company’s clientele values ISO 15378 a lot. This includes many giant multinational pharmaceutical companies. He added that the ISO standard both complements and supports regular and precise consumer audits.
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