Industrial bioseparation equipment

Chapter 16 provides guidance relating to the choice of industrial bioseparation equipment that is available and the issues that must be taken into account when selecting a suitable system to meet both technical and economic objectives. 

The complexity of many industrial bioseparation equipment items means that the design and construction can be time consuming, particularly if process development is required to test the equipment on a typical product to see if it will work at the larger scale. It is not unusual to have 6 to 9 month delivery periods for this type of equipment, and even when delivered, it will be necessary to install, commission, and validate it. Therefore, the project program must recognize the long duration for introducing commercial bioseparation equipment. 

In moving from laboratory- or pilot-scale processing to full-scale manufacturing, it can be difficult to scale up certain types of bioseparation equipment easily for example, high g centrifuges are available as bench-mounted units (using test tubes), but an equivalent industrial machine with a similar g force is unlikely to be a cost-effective solution, even if it were possible to build a suitable unit. It would not be realistic to consider 10 or 100 identical units as a realistic alternative. Compromises are therefore required as a process is commercialized, to ensure that the process remains technically and economically feasible. 

Where small-scale bioseparations have been developed, particularly in the biopharmaceutical industry, there has been a tendency to retain laboratory type equipment even if this results in more labour and capital intensive processing. The reason for this is often to avoid the need for extended periods of process development work with new equipment designs, which might delay the launch of a product where competitors are not far behind. Manufacturers are also wary of adopting new bioseparation techniques for processes if there is any risk that regulators such as the U.S. Food and Drug Administration (FDA) will require more evidence that the equipment is fit for the purpose. This conservative tendency is understandable and may influence the choice of bioseparation equipment for pharmaceutical manufacturing in particular. 

At industrial scale, careful consideration of the materials of construction for the bioseparation equipment is vital to ensure that the product does not become contaminated, by rust, for example, and also to assure long plant life with good reliability to maximize throughput. Materials that were suitable on a laboratory or pilot scale may no longer be appropriate, where the process and mechanical demands on the equipment may be greater. For example, the plant could be located outside where there are greater extremes of temperature in summer and winter, or equipment may need to be steam sterilized in situ rather than being autoclaved. 

The specification for bioseparation equipment will depend on its location, for both mechanical and electrical components. The need to weatherproof a piece of equipment and protect it from rain, wind, and temperature extremes will require specific provision to be made. Equipment located indoors will not necessarily require such features, although cleaning down of plant areas with hoses, as is common in the food industry, requires some degree of protection against water ingress for electrical items such as motor drives, control panels, and instruments. 

In the industries using bioseparations described above, there is a great variation in terms of production scale and product quality between waste water treatment and pharmaceutical production. This will obviously affect the choice of equipment for the process, although in many cases the principle on which bioseparation is based will be common. For example, centrifuga-... 

Elickinger, M. C. and S. W. Drew. 2010. Encyclopedia of Industrial Biotechnology Bioprocess, Bioseparation, and Cell Technology. (7 vols.) New York John Wiley Sons. Online Knovel, Wiley Online Library. This new edition is based on the Encyclopedia of Bioprocess Technology (Elickinger and Drew, 1999) and the Encyclopedia of Cell Technology (Spier, 2000). The encyclopedia covers all aspects, both theoretical and practical, of industrial biological processes, techniques, and equipment. 

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