NC-Free, your route to peace of mind solutions in pharmaceutical packaging

Nitrosamines are common in food and water but were found to be present in certain medications above the FDA’s internationally recognized acceptable daily intake limit. Although in the pharmaceutical industry there are no limits for the packaging materials themselves, recent drug recalls due to high levels of nitrosamine formation further highlighted the need to reduce the potential risk of nitrosamine formation at all stages of the manufacturing process. As a responsible healthcare packaging manufacturer Amcor was compelled to actively search for solutions.

Through our investigations, it was found that nitrosamines may form when the nitrogen oxides of nitrocellulose inks used for certain blister materials react with non-intentionally added secondary and tertiary amines present during the manufacturing process and may then transfer to the product under certain packaging operations. Amcor can however offer customers peace of mind in knowing that the raw materials we source do not intentionally contain the secondary amines which may cause this reaction.

Nonetheless, it is a requirement of the European Medicines Agency (EMA) that pharmaceutical companies ensure that the presence of nitrosamine impurities in medicinal products is controlled and is kept as low as possible. While the risk of nitrosamine contamination above the acceptable daily levels from nitrocellulose degradation in packaging is extremely unlikely, Amcor found that this risk can be eliminated entirely by transitioning to our NC-Free solution. For pharmaceuticals with high dosing levels, Amcor can offer packaging solutions which are nitrocellulose-free for both the aluminium print primer and the printing inks.

In addition to certifying independently, through an external laboratory, that our NC-Free solution is 100% nitrosamine free, Amcor can also deliver the printing expertise needed for flexibility and cost effectiveness. Trials of our NC-Free material have shown excellent machineability, comparable in performance to the nitrocellulose-based technology, and this means we can offer the new specification in a wide range of printing options for both short and long runs – such as digital, UV Flexo, and rotogravure.

Amcor is dedicated addressing customers’ challenges and working together to find solutions to industry problems. With leading experts to advise on both the printing and regulatory documentation needed, Amcor is best placed to accelerate the time to market for those adopting our NC-Free solutions.