Testing for extractables and leachables in packaging materials for medical devices

Packaging materials, such as plastic, play a vital role in protecting both the drug and the patient. In recent years, risk management in extractable and leachable testing for these packaging materials has revealed an increase in the challenges faced during testing. Reducing packaging costs, protecting new generations of drugs from light and oxygen and the needed adaptation of testing strategies to ensure the material is protecting rather than harming are just some of the challenges that need to be overcome.

Pfizer recently developed and implemented a comprehensive extractable and leachable program for biologics to ensure patient safety. Their holistic approach uses both risk-based evaluation and testing strategies to systematically assess potential risks associated with all process stream contact materials and container closure systems (CCS). Neil Steinmeyer, Principal Scientist at Pfizer states that the main process equipment risks that are considered include; proximity to the bulk substance or drug product, the extraction capability of the process stream, the product contact surface area, duration of contact, temperature and the inherent resistance of the material to extraction.

In addition to testing for biologics, Stephen Duckworth, Head of Global Segment at Clariant notes that increasingly, substances such as pigments and functional additives are used to enhance the properties of the polymer to, for example, help easy identification by colours, improve release properties of closures or to protect the polymer during gamma sterilisation. Reacting to this trend, regulations have become tougher. The FDA has stated that anything added to the polymer should be considered a contaminant, and that the impact of such changes in the supply chain could invalidate historical test data, adding to the already challenging and complex task of extractables and leachables testing for packaging materials.

And those aren’t the only challenges faced - with combination products, the testing strategies get more complex as it involves assessing the suitability of a particular material for use in a container closure, delivery device or both. Cheryl Stults, Principal at C&M Technical Consulting states that the type of information required to confirm suitability for use may be different for a container closure than for a device, requiring a need for the integration of information sources and the development of a simplified E&L and biocompatibility test plan.

Xuejen Liu, Senior Scientist at Johnson & Johnson adds to the discussion the need for stringent testing of the packaging materials for permanently implantable medical devices. These materials include various components such as folders, trays, lids and labels made from a wide range of materials including foil, polymeric materials, coated papers and more. The major analytical challenge faced with testing these materials is how to identify and quantitate the extractable compounds in the extracts.

Assessing potential risks in all packaging materials for medical devices through extractables and leachables testing is such an important factor in ensuring efficacy and safety. Despite the numerous challenges and complex tasks faced with these methods and processes, strategic approaches to testing these materials have become more efficient and have resulted in an increase in the safety of products.

Neil, Stephen, Cheryl and Xuejen will all be presenting case studies on extractables and leachables testing in packaging materials at Extractables & Leachables USA 2016. You can find out more about the conference and the ‘Packaging Materials and Methods’ section here.