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20 BioPharm International eBook June 2019 Single-Use Systems Extractables and Leachables Extractables and Leachables: Determining Risk in Single-Use Systems As SUS become prevalent in the biologics industry, the question of safety becomes increasingly important. S ingle-use systems (SUS) are increasingly becoming the norm in biologics development and manufacturing. Approximately 85% of the pre-commercial biopharmaceutical sec- tor use SUS, and they are increasingly being adopted for commercial manufacturing. SUS have significant advantages but are not without drawbacks. A 2018 survey showed that 73.3% of biologics insiders listed contamination from extractables and leachables to be a major problem (1). SINGLE-USE SYSTEMS While a limited number of SUS products were tra- ditionally used in biologics manufacturing, such as filter membranes and silicone tubing, a major shift took place in the 2000s with the introduction of new SUS products. Today, SUS are used for a variety of pur- poses, including filters, process containers (bags), tubing, connectors, gaskets, valves, and packaging (finished products). Growth in the SUS sector has been rapid, a trend that is predicted to continue. In 2013, SUS in the phar- maceutical industry was worth approximately $1.4 billion, by 2018 it had reached $3.5 billion, and it is estimated the sector will reach $11 billion by 2023 (1). fotoblin - ANDREAS NIXDORF is Business Development Manager Extractables & Leachables Testing at SGS. ANDREAS NIXDORF

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