Healthcare Packaging

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 the control and production of primary packaging materials is extremely important to ensure patients’ safety. This is because while using 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.  The certification also includes compliance with certain directives applicable to packaging components used in pharmaceutical practices.

According to Andy Walti, leader of Clariant’s Healthcare Packaging Business, the company has committed to serving 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 with the GMPs, which is critical for serving an extremely challenging and regulated sector.

The Clariant business produces a complete range of controlled atmosphere packaging solutions. These include equilibrium sorbents, pharmaceutical desiccants, adsorbent polymers and oxygen scavengers in addition to pharmaceutical containers and closures. Both passive and active packaging technologies are employed to enable the unit to 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.

The Importance of ISO 15378

ISO 15378 certification is important because it assures customers that the company is following a set of internationally recognized quality standards. This can give customers peace of mind that they are doing business with a reliable company. Additionally, ISO 15378 certification can help companies improve their operations and become more efficient.

The benefits of holding ISO 15378 certification are many. First, it assures customers that your quality management system is compliant with the standard and meets the requirements of a quality management system. This gives customers confidence in your products and services and builds trust between you and your customers. Additionally, ISO 15378 certification demonstrates your commitment to quality and continuous improvement, which can help you attract new customers and retain existing ones.

Who is Clariant?

Clariant is a Swiss chemical company that focuses on specialty chemicals. These are chemicals that have unique and specific applications, such as in the production of plastics, paints, and other consumer goods. Clariant’s products are used in a wide range of industries, including automotive, construction, and packaging. The company also produces a variety of performance additives that are used to improve the quality and durability of finished products.

Clariant also specializes in healthcare packaging, and it manufactures medical packaging products. They offer a wide range of products, including  syringes and vials, labelling & adhesive products, and sterilization packaging lines. Their products are designed to meet the needs of pharmaceutical and medical device companies, as well as hospitals and other healthcare facilities.

The Acquisition of Clariant Healthcare Packaging Division

US private equity firm Arsenal Capital Partners completed the acquisition of the healthcare packaging division of Clariant in 2019 for a deal worth $313.59m.  Following this deal, Arsenal Capital Partners rebranded the healthcare division to Airnov Healthcare Packaging.  Airnov is a business that produces anti-oxidation products for pharmaceutical markets.  The products they offer range from integrated desiccant systems, canisters, packets, plastic bottles, and other types of flexible packaging.

For more information on ISO 14644 clean room standards click here.