The drug approval process is about more than just pharmaceutical R&D. Before a new drug is launched, pharmaceutical companies and their packaging suppliers must also ensure that at no point in the drug’s shelf life harmful substances are released from the packaging material or that substances released from the packaging material interact with the drug to render it harmful or ineffective. To manage this risk, packaging materials are subject to rigorous testing for so-called extractables, i.e., any chemical compounds that can be released under defined conditions. This helps drug manufacturers to determine if the extractables are at risk of becoming so-called leachables, i.e., compounds that are released from the packaging material during the product lifecycle under real-life conditions. Leachables pose a real risk for patients, as they may expose them to hazardous substances or prevent their treatment from working effectively.
Our pharmaceutical clients are responsible for testing for leachables, as it involves an analysis of how their medicines behave in contact with our packaging materials. At Constantia Flexibles, our focus is on testing our own materials for extractables, as we don’t have access to the drugs themselves. “We are one of a few top-tier pharmaceutical packaging companies that offer comprehensive testing of primary packaging materials,” explains Georg Schitter, Analytical Laboratory R&D at Austria-based Constantia Teich, “due to the high cost of the testing equipment as well as the highly skilled personnel to operate it.”