ABSTRACT
Cycle development is the process of integrating the cleaning agents (discussed in Chapter 2), the cleaning method (discussed in Chapter 3), and the various process parameters (discussed in Chapters 4 and 5) into a usable, validatable cleaning Standard Operating Procedure (SOP). Each facility must determine the best balance for its needs within the constraints of having a validated process. While it is necessary to clean the manufacturing equipment to predetermined acceptance criteria, it is also necessary to make sure that the cleaning process is consistent and controllable and thus validatable.
