White Paper

Demystifying Extractables Testing

Source: Parker Bioscience

By Graeme Proctor, Product Manager (Single Use Technologies), Parker Hannifin Manufacturing Limited and Nick Morley, Principal Scientist, Hall Analytical

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The increased focus by biomanufacturers on smaller patient populations is driving the adoption of technologies and solutions that can improve flexibility and process efficiency while also lowering overall costs. As a result, the application of single-use technology (SUT) is growing rapidly, this technology is being used for a range of applications in drug development. Its benefits include reduced cleaning requirements, decreased plant footprint and capital investment, improved batch turnaround times, increased process flexibility, and a significantly lower risk of product cross-contamination.1 Yet, while SUT offers a number of advantages, there are also factors that must be considered when adopting an SUT strategy, such as the presence of extractables and leachables (E&L).

Various interested parties have developed guidances that discuss extractable analysis of single-use components/systems, each with subtle differences. It is critical that anyone utilizing SUT understands these differences and which testing approaches are most suited to the study goals.