Manufacturing and Production

Cleanroom Design, Classification and Environmental Monitoring

A cleanroom is a controlled environment only while it is being operated correctly, and most excursions trace to movement, gowning or a pressure cascade that reversed rather than to the room itself. This course covers both the engineering and the behaviour. Delegates work through classification, the particle limits at each grade and the difference between at rest and in operation states. Airflow design follows, including unidirectional and turbulent flow, air change rates, filtration and the recovery testing that proves a room can clean itself. Pressure cascades and airlocks are addressed, including the direction of flow between grades. Gowning and personnel flow are covered, since operators are the largest particle source in any room. Material transfer and disinfection follow. Environmental monitoring is treated in detail: viable and non viable sampling, site selection, frequency, alert and action limits and trend review. Disinfectant rotation and efficacy are covered. The course closes on requalification, on excursion investigation and on inspection expectations.