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Determination of Extractables and Leachables from Single‐Use Systems
Author(s) -
Ding Weibing
Publication year - 2013
Publication title -
chemie ingenieur technik
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.365
H-Index - 36
eISSN - 1522-2640
pISSN - 0009-286X
DOI - 10.1002/cite.201200113
Subject(s) - biomanufacturing , process engineering , biochemical engineering , quality (philosophy) , biopharmaceutical , computer science , manufacturing engineering , engineering , risk analysis (engineering) , business , philosophy , genetics , epistemology , biology
Single‐use systems have been increasingly used in biopharmaceutical manufacturing processes. Despite their multitude of advantages, these plastic and elastomeric assemblies also draw concerns about chemical compounds that may migrate to finished products and impact product quality or safety. Evaluation of such extractables/leachables and their potential impact remains a challenge to many suppliers and end users. Based on extensive experience on filter extractables study, a practical and science‐based approach for determination of extractables/leachables from single‐use systems used in biomanufacturing has been developed. The general procedure is presented through a case study.