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Handbook of Downstream Processing - E. Goldberg

Handbook of Downstream Processing

Hardcover Published: 31st October 1996
ISBN: 9780751403640
Number Of Pages: 720

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The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized­ in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?

`... the book offers a great deal of useful information for readers.' Angewandte Chemie

Conversion Table
Mechanical disruption of cellsp. 1
Conventional filtrationp. 20
Pharmaceutical applications of liquid-liquid extractionp. 48
Affinity adsorptionp. 70
Membrane separations in downstream processingp. 90
Electrodialysisp. 140
Large-scale column chromatography - a GMP manufacturing perspectivep. 167
Product recovery and purification via precipitation and crystallizationp. 185
Lyophilizationp. 203
Drying in the pharmaceutical and biotechnology fieldsp. 235
Sterilization in the pharmaceutical and biotechnology industryp. 261
Pharmaceutical packaging operationsp. 309
Clean-in-place and sterilize-in-place systemsp. 318
Controls and automation for biotechnology and pharmaceutical industriesp. 335
Agitation in fermenters and bioreactorsp. 357
Distillation in the pharmaceutical industryp. 417
High purity waterp. 456
The facility design processp. 509
Clean room testing and certificationp. 530
Regulatory considerationsp. 557
Validationp. 569
Project execution for the design and construction of a biotechnology facilityp. 601
Bulk pharmaceutical and biopharmaceutical plant design considerationsp. 623
Optimization of protein recovery using computer-aided process design toolsp. 658
Off-site constructionp. 682
Waste water treatment in the pharmaceutical industryp. 688
Indexp. 705
Table of Contents provided by Blackwell. All Rights Reserved.

ISBN: 9780751403640
ISBN-10: 0751403644
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 720
Published: 31st October 1996
Publisher: Chapman and Hall
Country of Publication: GB
Dimensions (cm): 23.4 x 15.6  x 5.08
Weight (kg): 2.67