FDA 2004 Guidance for Industry EU Annex 1 USP <1072> ISO 13408-1 and 14698 USP general information chapter <1116> “Microbial Evaluation and Classification of Clean Rooms and Other Controlled Environments” PDA- 13 (Fundamentals of an Environmental Monitoring Program) Colony Forming Unit (CFU): A single macroscopic colony formed after the introduction of one (or more) microorganism(s) to a microbiological growth medium. Continuous Monitoring: A process of data collection where conditions are monitored continuously throughout the operation. In most U.S. applications, this definition implies “during production.” For ISO applications, this means twenty-four hours per day, seven days a week. Frequent Monitoring: A process of collecting data where conditions are monitored at least once per hour. In most U.S. applications, this means during production. In most ISO applications this means twenty-four hours per day, seven days per week. Disinfection: The ch...