It is well known within the pharmaceutical industry that Constantia Flexibles is the ideal partner when it comes to developing innovative, effective solutions to today’s biggest challenges. In a recent development project, we achieved a fast turnaround on some ground-breaking new inks and primers as part of the industry-wide effort to minimize the risk of NDMA/NDEA contamination in drugs.
When traces of nitrosamines were discovered in an active pharmaceutical ingredient in 2018, the pharmaceutical industry sprang into action – even though the risk to humans is quite minimal. Constantia Flexibles issued a special edition of the Pharma newsletter in mid-2019 to clarify the guidance from the European Medicines Agency (EMA) that suggested packaging might play a role. Although nitrocellulose-based inks and primers used in the packaging process could in theory become nitrosating agents, tests have shown that both the likelihood of nitrosamine formation and the health risk associated with it are very low for our packaging.
The fact that there was even a minimal risk, however, was enough to convince the stakeholders involved to come together and eliminate the risk once and for all. When we received a request to collaborate on the development of nitrocellulose-free inks and primers to prevent even the slightest risk of nitrosamines being formed during the packaging process, we jumped at the chance! A team of experts from the Product Excellence Center Blister and the Competence Center Aluminum Foil & Foil Laminates at Constantia Flexibles partnered with various ink suppliers to put several different solutions to the test – which was a lot easier to accomplish during the pre-COVID, pre-lockdown days. Thanks to our collaborative development efforts, we ultimately succeeded in finding a solution that achieved results comparable to those of the NC-based inks already in use.
Constantia Patz was proud to present the first market-ready inks and primers that are entirely free of nitrocellulose in the first quarter of 2020. Working on this forward-looking development with partners in the inks sector and the pharmaceutical industry was a great experience and a worthwhile endeavor that will offer benefits to other customers and all consumers for years to come. To find out more about our nitrocellulose-free inks and primers solutions for pharmaceutical packaging, get in touch with us.