Following a recent guidance issued by the European Medicines Agency, questions have arisen as to the possible role of printing primers and inks in the formation of nitrosamines in human medicines. Constantia Flexibles would like to provide more clarity for our customers on this topic and reaffirm that our number one priority is delivering reliable packaging products that meet the highest quality standards and ensure the safety and compliance of all marketed products.
After minimal traces of nitrosamines were detected in certain medicines over the past year, the European Medicines Agency (EMA) has urged manufacturers to evaluate the risk of contamination in their own products. The Agency provided relevant guidance on October 9, 2019 in a document entitled “Questions and Answers on Information on Nitrosamines for Marketing Authorization Holders.” The document outlines eight possible sources of nitrosamine contamination, among them what EMA refers to as “certain packaging materials.” This section cites the hypothesis of one Marketing Authorization Holder (MAH) suggesting that “lidding foil containing nitrocellulose printing primer may react with amines in printing ink to generate nitrosamines, which would be transferred to the product under certain packaging process conditions.”
Let us first reassure you that extremely low levels of nitrosamines pose only a minimal risk to humans and, as a result, no regulators have sought to restrict, ban, or recall any of these packaging materials. Second, it is important to note that these contaminants are not being introduced intentionally during the packaging process. Nitrosamines are organic chemical compounds that form when nitrosating agents react with aliphatic amines. In theory, nitrocellulose-based inks and printing primers could become nitrosating agents under certain circumstances, for example at elevated temperatures like those present in the heat-sealing process for blister packs. And, in theory, those agents could react with secondary amines present in the production process, for example from certain commercial organic pigments or UV inks.
Based on the available data, we believe that both the health risks associated with trace amounts of nitrosamine and the likelihood of nitrosamines being transferred to medicines during the packaging process are very low. What is more, many products within Constantia Flexibles’s pharmaceutical portfolio do not contain the precise combination of raw materials theoretically needed to form the chemical compound in question. At our facilities and across the industry, there is a wide range of primary packaging materials in use today that totally eliminates the risk of nitrosamine formation.
In closing, we would like our customers to rest assured that the medicines and the packaging products on today’s markets are safe and that we have reliable systems in place to make certain they stay that way. If you have any further questions about Constantia Flexibles’s blister lidding solutions that address the issues raised here, please do not hesitate to get in touch with us at pharma(at)cflex.com.
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