ABSTRACT

Active pharmaceutical ingredients (APIs) are the drug substances generally

produced by chemical synthesis or chemical manipulation of materials derived

from biological origins. The most important trend in APIs is that these materials are

becoming more potent or more specific in their biological target. Another trend has

been the design of facilities for multiproduct or multipurpose production. These

two trends have ignited interest in incorporating the concept of clean-in-place (CIP)

technology into bulk API facilities.