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Weibing Ding Determination of Extractables and Leachables from Single-Use Systems Chemie Ingenieur Technik 85

Article first published online: 15 NOV 2012 | DOI: 10.1002/cite.201200113

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Although single-use systems are commonly used in biopharmaceutical production the issue of extractables and leachables that possibly migrate to the products is unsolved. Therefore, a practical, science-based approach for determination of extractables and leachables from single-use systems is presented on the example of a case study.

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