ABSTRACT
The issue of a controlled environment in the pharmaceutical industry in the processing of drugs or medical devices that would be ultimately terminally sterilized or terminally sterilized has taken center stage in increasing the anxieties of regulators and manufacturers alike. The terminology used, especially on a global level, is sometimes as important as, if not more than, the contents of regulations, guidelines, and other assorted technical information vehicles that have been published or proposed. Controlled environments are environments where the processing of drugs and medical products are conducted, where a specified number and type of measurable indicators are continuously or intermittently measured and compared against standards or targets to provide a historical status of critical conditions that are related to the quality of final products. Clean rooms are controlled environments where parameters such as airflow, microbiological and particulate quality of air, equipment surfaces and other room surfaces, and personnel equipment are monitored and compared to standards or targets.
