ABSTRACT
Manufacturing pharmaceutical products is a highly controlled process, whether the end product is aseptic, terminally sterilized, lyophilized, or even an originating bulk ingredient. This chapter reviews how monitoring total particle counts within controlled areas is performed, the presence and interaction of particles in clean rooms, fundamental particle counter technologies and design principles, the legislative requirements for monitoring, how monitoring can be performed, and the considerations behind sampling techniques applied to monitoring. Particle monitoring is required to prove contamination control of an environment. This includes the measurement of air in a clean room associated with personnel and process equipment activities, with regard to risk of finished product quality. Particle counting, in addition to the measurement of airflow patterns and air velocity, temperature, and relative humidity, and of differential air pressure between adjacent rooms, can be vital in ensuring operations are at optimum performance.
