ABSTRACT
This chapter explores some perspective the reasons for good cleaning programs and to provide a better understanding of why pharmaceutical cleaning must be more stringently controlled than cleaning in other industries, such as the food industry. The issue of cleaning in pharmaceutical facilities has recently assumed greater importance to Food and Drug Administration (FDA) inspectors as they conduct regulatory inspections. The FDA’s expectation is that the cleaning of pharmaceutical equipment must be studied and conducted in a scientific manner. Cleaning is very important in the manufacture of in vitro products, because any trace cross-contamination can lead to false or misleading test results. If cleaning agents or detergents are used in the cleaning process, there must also be maximum allowable carryover limits established for the materials. The same is true for sanitizing agents, disinfectants and, in some cases, even excipients.
