Abstract
Environmental control plays an important role in preventing contamination of pharmaceutical products, whether from the air, personnel, or from other products and materials. The level of risk from the environment is tied directly to the risk of environmental contamination reaching the patient. This chapter discusses the requirements for Clean Rooms and other operating environments and the heating, ventilation, and air conditioning (HVAC) systems that are designed to ensure control of these environments. It outlines the requirements to qualify controlled environments. The qualification program should be designed to demonstrate that these requirements are met by the design, construction, operation, and performance of the facility and the environmental control systems. All HVAC systems are designed to provide some degree of environmental control. Filters are an important component of clean room environmental control systems. These are the functional particulate removal devices necessary to remove airborne particulate.
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