ABSTRACT
Qualification of controlled areas where terminally sterilized devices are manufactured or aseptic fill operations are performed is a key component in ensuring product quality. Environmental control system shall be periodically inspected to verify that the system, including necessary equipment is adequate and functioning properly. Concurrently, a set of procedures for cleaning and personnel practices should be developed with the intent of maintaining the controlled environment at selected classification level. These comprehensive procedures should be augmented by an intensive training program to ensure that all elements are understood by the operators. The most serious source of contamination in a clean environment is the people who work in the rooms. Validation of the room during normal operation commences and consists of a formal program based on routine monitoring over time. After the room design has been determined, the room built and the work flow established the validation program monitors the following elements: lighting, ventilation, temperature, relative humidity, particulate matter and static electricity.
