Whilst prefilled syringes offer many advantages for delivery of complex pharmaceutical drug products, they also present a range of risks associated with unwanted contamination from or interaction with the drug product. As prefilled syringes contain a multitude of different materials which can potentially release leachables into the formulation, analytical screening and control is required to ensure a safe product. All potential sources of unwanted contamination must be explored through robust extractables and leachables studies. In this case study, we describe an effective extractables and leachables study design and approach whilst highlighting some critical aspects during testing which should be considered in order to avoid misleading results.

Meet our Expert
Dr. Tino Otte, is the Head of Sales and Consulting at Intertek in Switzerland. He joined the company in 2016. Tino has specialized in extractables & leachables studies, impurity characterization and analytical method development and has over 13 years of experience in analytical chemistry, pharmaceuticals and polymer characterization. He holds a degree in polymer-chemistry from the University of Halle/Saale and a Ph.D. from the Darmstadt Technical University, where he graduated in 2010. Prior to joining Intertek, he worked at different CROs and Analytical Instrument Manufacturers in Switzerland and Germany, such as UFAG Laboratories or Hamilton AG.

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