The last step in the separation process for a biological product is usually drying, which is the process of thermally removing volatile substances (often water) to yield a solid. In the step preceding drying, the desired product is generally in an aqueous solution and at the desired final level of purity. The most common reason for drying a biological product is that it is susceptible to chemical (e.g., deamidation or oxidation) and/or physical (e.g., aggregation and precipitation) degradation during storage in a liquid formulation. Another common reason for drying is for convenience in the final use of the product. For example, it is often desirable that pharmaceutical drugs be in tablet form. Additionally, drying may be necessary to remove undesirable volatile substances. Also, although many bioproducts are stable when frozen, it is more economical and convenient to store them in dry form rather than frozen. Drying is now an established unit operation in the process industries. However, because most biological products are thermally labile, only those drying processes that minimize or eliminate thermal product degradation are actually used to dry biological products. This chapter focuses on the types of dryer that have generally found the greatest use in the drying of biological products: vacuum-shelf dryers, batch vacuum rotary dryers, freeze dryers, and spray dryers . The principles discussed, however, will apply to other types of dryers as well. We begin with the fundamental principles of drying, followed by a description of the types of dryer most used for biological products. Then we present scale-up and design methods for these dryers. After completing this chapter, the reader should be able to do the following: • Do drying calculations involving relative humidity using the psychrometric moisture chart and the equilibrium moisture curve for the material being dried. • Calculate the relative amounts of bound and unbound water in wet solids before drying. • Model heat transfer in conductive drying and calculate conductive drying times. • Interpret drying rate curves. • Calculate convective drying times of nonporous solids based on mass transfer.
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