Filtration in the Biopharmaceutical Industry

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9780824798963: Filtration in the Biopharmaceutical Industry
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Offering a comprehensive examination of developments in the field, this book delineates filtration in a host of applications. Addressing quality, security, economic, process development, and regulatory topics, the book covers pre- and sterility grade filters, charge-modified filter media, and aids to filtration, discusses filter quality assurance, pore size, extractables, and compatibilities in various filters, examines filter design and construction, analyzes integrity testing, test sensitivity, and automation, furnishes novel filtration flow methods, explains filter validation, summarizes the U.S. Food and Drug Administration regulations governing filtration, and more.

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"As the authors so correctly state, the responsibility for validation remains exclusively that of the drug manufacturer. To understand the claims of the filter companies, however, the drug manufacturer needs the knowledge contained in this relevant, comprehensive book." -European Journal of Pharmaceutics and Biopharmaceutics Promo Copy

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Published by CRC Press (1997)
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