ABSTRACT

This chapter describes a process of the evolution of a multiproduct facility design through an integrated approach; it is not simply a description of the desirable architectural and mechanical features of a multiproduct facility. A processing area intended for organic synthesis will not have compatible design features for it to be used simultaneously or sequentially for biosynthetic operations, without extensive compromise of one or both processes. Preparing a draft validation master plan, which describes the validation requirements, in advance of the detailed design stage is a useful method of identifying these specifications. It clarifies the principal concerns of multiproduct processing, presents the prevailing industry and regulatory viewpoints, suggests an integrated, facility design development strategy, and reviews general biotech facility design requirements with an emphasis on desirable features to include in a multiproduct context.