Handbook of Downstream Processing

✍ Scribed by J. R. Millis (auth.), Elliott Goldberg (eds.)

• Publisher: Springer Netherlands
• Year: 1996
• Tongue: English
• Leaves: 744
• Edition: 1
• Category: Library

✦ Synopsis

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?

✦ Table of Contents

Front Matter....Pages i-xxvii
Mechanical disruption of cells....Pages 1-19
Conventional Filtration....Pages 20-47
Pharmaceutical applications of liquid—liquid extraction....Pages 48-69
Affinity adsorption....Pages 70-89
Membrane separations in downstream processing....Pages 90-139
Electrodialysis....Pages 140-166
Large-scale column chromatography — a GMP manufacturing perspective....Pages 167-184
Product recovery and purification via precipitation and crystallization....Pages 185-202
Lyophilization....Pages 203-234
Drying in the pharmaceutical and biotechnology fields....Pages 235-260
Sterilization in the pharmaceutical and biotechnology industry....Pages 261-308
Pharmaceutical Packaging Operations....Pages 309-317
Clean-in-place and sterilize-in-place systems....Pages 318-334
Controls and automation for biotechnology and pharmaceutical industries....Pages 335-356
Agitation in fermenters and bioreactors....Pages 357-416
Distillation in the pharmaceutical industry....Pages 417-455
High purity water....Pages 456-508
The facility design process....Pages 509-529
Clean room testing and certification....Pages 530-556
Regulatory considerations....Pages 557-568
Validation....Pages 569-600
Project execution for the design and construction of a biotechnology facility....Pages 601-622
Bulk pharmaceutical and biopharmaceutical plant design considerations....Pages 623-657
Optimization of protein recovery using computer-aided process design tools....Pages 658-681
Off-site construction....Pages 682-687
Waste water treatment in the pharmaceutical industry....Pages 688-704
Back Matter....Pages 705-720

✦ Subjects

Biotechnology; Organic Chemistry