ABSTRACT
The accurate and consistent microbial monitoring of controlled rooms as a measure of quality control is an important measure in the manufacture of sterile and nonsterile pharmaceutical products. While it is a direct measure of the bioburden in the environment immediately surrounding the product manufacture, it cannot be overinterpreted as a measure of finished product quality (1), but rather a measure of the state of control of the facility and operations. Other chapters in this book deal with the importance of air-monitoring techniques; it is the purpose of this chapter to present the methods for microbial monitoring of surfaces. From the outset, we have to note that the link between surface sampling results, viable air monitoring, and personnel monitoring is a basic assumption of the industry, one that has never been demonstrated (2,3). In fact, recent data designed to test this assumption call its validity into question (4).
