ABSTRACT
This chapter addresses the items that differ between multiproduct and dedicated facilities as they relate to the development of a cleaning validation program. It discusses the need for multiproduct facilities, the changeover program, and equipment considerations. The chapter also addresses the issue of equipment dedication, and deals with a discussion of issues related to each of the several categories of equipment. The need for multiproduct biotechnology production facilities arises largely from the desire of manufacturers to minimize the cost, risks, and time associated with bringing new products to market. A multiproduct facility is a facility that is designed to accommodate the production of two or more products concurrently or on a campaigned basis. In a multiproduct facility designed solely for concurrent manufacturing, capital efficiency is achieved through the use of centralized utilities and support services. Multiproduct facilities can also reduce the financial risk associated with bringing a new product to market.
