Risk Assessment of Clean Room Used in Pharmaceutical Industries in Design, Manufacturing, Equipping and Operating Phases by FMEA Based on Some Chemical Engineering Concepts

A clean room is an environment commonly used in sensitive production lines, such as pharmaceuticals, food and so on, where dust, aerobic microbes, particulates and chemical vapors are kept in a low and controlled environment.  In this applied and new paper, for the first time, the assessment of the significant risks associated with the possible modes of risk in the design, construction, equipping and operation phases of a clean room, together with the risk factors and their consequences and effects, is investigated by the FMEA method. Preventive and control measures are suggested to mitigate the effects of the risks. In addition, risk numbers are calculated before and after preventive measures. It was founded that by taking appropriate and effective control measures (especially in the design and construction of a clean room), the risks could be significantly and effectively reduced. By taking precautionary measures, the risk numbers were reduced by 50% in each case, which halved the risk of occurrence.