Filtration and Purification in the Biopharmaceutical Industry
Filtration and Purification in the Biopharmaceutical Industry

Author: Maik J. Jornitz

Publisher: CRC Press

Published: 2007-11-28

Total Pages: 816

ISBN-13: 0849379547

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Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, in

Filtration and Purification in the Biopharmaceutical Industry, Third Edition
Filtration and Purification in the Biopharmaceutical Industry, Third Edition

Author: Maik W. Jornitz

Publisher: CRC Press

Published: 2019-06-26

Total Pages: 673

ISBN-13: 1351675699

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Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

Filtration in the Biopharmaceutical Industry
Filtration in the Biopharmaceutical Industry

Author: Theodore H. Meltzer

Publisher: CRC Press

Published: 1998-01-05

Total Pages: 950

ISBN-13: 9780824798963

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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.

Sterile Filtration
Sterile Filtration

Author: Maik W. Jornitz

Publisher: CRC Press

Published: 2020-04-15

Total Pages: 640

ISBN-13: 1420030094

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This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration!

Filters and Filtration Handbook
Filters and Filtration Handbook

Author: T. Christopher Dickenson

Publisher:

Published: 1992

Total Pages: 848

ISBN-13:

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This is a reference manual for the selection and application of filtration and separation products. The new edition is extended and updated to incorporate all the latest developments in filtration and separation technology supplied by both manufacturers and users. operators, consultants, as well as staff with responsibility for purchasing, planning, sales and marketing. It is directly relevant to numerous industries including water, fluid power, chemicals, pharmaceutical, food and beverages, processing, general engineering, electronics and manufacturing.

Filters and Filtration Handbook
Filters and Filtration Handbook

Author: Kenneth S Sutherland

Publisher: Elsevier

Published: 2011-04-18

Total Pages: 536

ISBN-13: 0080558046

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Filters are used in most industries, especially the water, sewage, oil, gas, food and beverage, and pharmaceutical industries. The new edition of this established title is an all-encompassing practical account of standard filtration equipment and its applications. Completely revised and rewritten, it is an essential book for the engineer working in a plant situation-who requires guidance and information on what's available and whether it's suitable for the job. Co-published with the Institution of Chemical Engineers. Co-published with the Institution of Chemical Engineers. - The leading practical engineering guide to filtration techniques, systems and their applications - Meets the needs of all key sectors where filtration is a critical process, including chemical processing and manufacture, food, oil and gas, air-conditioning and water - A comprehensive sourcebook and reference for plant engineers, process engineers, plant designers, filter media and filtration specialists and equipment specifiers

Chemical Engineering in the Pharmaceutical Industry
Chemical Engineering in the Pharmaceutical Industry

Author: Mary T. am Ende

Publisher: John Wiley & Sons

Published: 2019-04-08

Total Pages: 1435

ISBN-13: 111928550X

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A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.