The Guidelines is to provide guidance for monitoring and controlling microbial contamination in clean rooms and other controlled environments used for pharmaceutical microbiological examinations.      

Pharmaceutical clean zones refer to clean rooms, isolators, and other controlled environments for sterility testing or microbiological examinations for pharmaceutical products. Cleanliness applicable to clean rooms is classified into four classes—A, B, C, and D—according to the particulate size and concentration of airborne particles referencing the current edition of Good Manufacturing Practice for Pharmaceuticals. In order to maintain the stability of the operating environment and ensure accuracy of detection, microbiological monitoring, and control should be performed to maintain the risk of microbial contamination in controlled environments at an acceptable level.

This Guidelines includes requirements for personnel, parameter validation for as-built clean rooms, microbial monitoring methods, monitoring frequency and programs, monitoring criteria, alert and action levels, data analysis, and deviation handling, and microbial identification and control.