ABSTRACT
Summary Historically, the construction cost of buildings for core manufacturing areas in facilities using isolation technology is lower (reduced by 33%) than conventional aseptic processing areas, although it is offset by the higher costs of isolation equipment (greater than conventional equipment by 50%), resulting in a greater total capital cost. However, when validation and operation costs are considered, the cost-benefit analysis has been more difficult to quantify. When selecting the proper technology for a new project, it is important to weigh the advantages of increased sterility assurance levels (SAL) found with isolators against the overall increase in capital cost, while keeping in mind the overall lifecycle cost of the facility. It is the intent of this chapter to perform an analysis of capital, validation, and operating costs for a given facility scope, and to establish a more thorough comparison for the use of isolation and restricted access barrier systems (RABS) technology against conventional clean room design.
