ABSTRACT
This chapter focuses on equipment cleaning and its importance during the many stages of pharmaceutical product development from early formulation development through pre-approval inspection (PAI). It outlines general equipment cleaning requirements and translates those requirements into acceptable equipment cleaning strategies for pharmaceutical products throughout the various stages of product development. Equipment can be cleaned using various types of cleaning methods, including cleaning in place, cleaning out of place, and manual cleaning. Visual inspection provides a rapid assessment of equipment cleanliness and is used to verify that there are no areas within the processing equipment that contain residues that can be seen with the unaided eye. Equipment should be cleaned and stored to prevent contamination or carryover of a material that would alter the quality of the final product. Equipment cleaning is a critical element for a pharmaceutical manufactures, and is often a critical element that is evaluated by the Food and Drug Administration in a PAI.
