Environmental laws and regulations including permits are reviewed in this chapter. Included are the Federal Clean Air Act Amendment (CAAA), the Federal Clean Water Act (CWA) regulations, the Resource Conservation and Recovery Act (RCRA) or, as it is also known, the Solid Waste Disposal

Common, everyday water is a major consideration in a pharmaceu￾tical plant. The final product or any of its intermediate materials can only be as contaminant-free as the water available at that stage. Water may be an ingredient or used principally to wash and rinse product contact components and equipment. Water is also used to humidiethe air, to generate clean steam for sterilization, to cool or heat, as a solvent, for drinking and sanitary uses, etc. To better control this critical media

Crystallization is one of the oldest methods known for recovering pure solids from a solution. The Chinese, for example, were using crystallization to recover common salt from water some 5000 years ago. The perfection and beauty of the crystal which fascinated the early tribes now leads to a product of high purity and attractive appearance

“Evaporation is the removal of solvent as a vapor from a solution or slurry. The vapor may or may not be recovered, depending on its value. The end product may be a solid, but the transfer of heat in the evaporator must be to a solution or a suspension of the solid in liquid if the apparatus is not to be classed as a dryer. Evaporators are similar to stills or re-boilers of distillation

n 1850 Thompson['] reported the first ion exchange applications which used naturally occurring clays. However, ion exchange resins have only been used in biochemical and fermentation product recovery since the

must also consider heating andor cooling requirements as well as to deliver the desired head pressure to overcome hydraulic pressure drop. Operating costs must also consider equipment maintenance, cost of cleaning chemicals and labor costs

The theoretical concepts underlying filtration can be applied towards practical solutions in the field. Comprehension of the basic principles is necessary to select the proper equipment for an application. Theory alone, however, can never be the basis for selection of a filter. Filtration belongs to the physical sciences, and thus conclusions must be based on experimental assay. It is, however, helpful in understanding why a slurry is more suitable for one design of filtration equipment than another

The introduction of fluidfoil impellers, as shown in Fig. 9a through 9f, give a wide variety of mixing conditions suitable for high flow and low fluid shear rates. Fluidfoil impellers use the principles developed in airfoil work in wind tunnels for aircraft. Figure 10a shows what is desirable, which is no form separation of the fluid, and maximum lift and drag coefficients, which is what one is trying to achieve with the fluidfoil impellers. Figure 10b shows

A common problem for a biochemical engineer is to be handed a microorganism and be told he has six months to design a plant to produce the new fermentation product. Although this seems to be a formidable task, with the proper approach this task can be reduced to a manageable level. There are many ways to approach the problem of optimization and design of a fermentation process

When designing a fermenter, one primary consideration is the removal of heat. There is a practical limit to the square feet of cooling surface that can be achieved from a tank jacket and the amount of coils that can be placed inside the tank. The three sources of heat to be removed are from the cooling of media after batch sterilization, from the exothermic fermentation process