ABSTRACT
Cleaning and cleaning validation remain major concerns both for product quality and from a regulatory perspective. This chapter discusses the concepts involved in cleaning chemistry, cleaning systems, and the validation of cleaning processes. Cleaning has both a direct and an indirect effect on product quality. The obvious direct effect is contamination. The cleaning approaches for equipment used in the biopharmaceutical industry have been derived from methods developed in the traditional pharmaceutical industry. Clean-in-place (CIP) is the preferred method of cleaning for both traditional pharmaceutical and biopharmaceutical industries. CIP is preferred because it is relatively easily automated, and automation implies that control is repeatable. The development of a cleaning validation plan is one of the most valuable activities for ensuring the success of a cleaning validation effort. Traditionally, validation protocols come in at least three categories: installation qualification, operational qualification, and process or performance qualification.
