Pharma and HPC Insights 05/2019

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.”

Our testing team at the Constantia Teich Competence Center uses advanced technology such as mass spectroscopy and chromatography to conduct material characterization tests and to determine which substances are released in what quantities after exposure to various conditions. The analysis starts with individual raw materials and continues through to complex finished products like multi-layer laminates, offering more in-depth insights than tests on the packaging line. Customers can consult with us and our data to find the best packaging solution for their products and work with us to achieve an optimum result even before the approval process begins. With the cost and complexity involved in bringing pharmaceutical products to market, the ability to substantially speed up the extractables and leachables testing processes is no small thing. “Having access to our testing data is invaluable for our pharmaceutical clients,” Schitter says. “Not only does it ensure the safety of their products, but it also saves them time and money.”