ABSTRACT

This chapter explores some of the most important criteria for design of cleanable process systems and equipment. The single most important consideration in the development of a cleanable process system is the integration of appropriate cleaning technology into the overall process system design at the conceptual and schematic stages of design. Several types of clean-in-place (CIP) cleanable pumps are commonly used in biopharmaceutical manufacturing processes. The CIP return point for this cycle will be adjacent to the large bioreactor and, for containment reasons, will be segregated by double block and bleed valving. Proper equipment design for cleanability can yield significant benefits: cleaning time can be reduced, chemical use and energy costs can be minimized, and the amount of manual cleaning and disassembly required can be reduced. Proper equipment design for cleanability is especially important for start-up, validation, and approval of multiple use facilities.