Discussion on pharmaceutical clean air conditioning system design based on HACCP risk assessment

Corresponding to the ISO 14644 series standards for cleanrooms and associated controlled environments, the GB/T 25915 series standards of China’s cleanroom industry have also been updated accordingly in 2021. This paper reviews and compares the changes in cleanrooms and associated controlled environments based on the old and new versions of GB/T 25915, part 1 and part 2. According to the requirements of risk assessment in the new version, combined with the design experience of clean air conditioning systems in pharmaceutical factories, the risk assessment method of hazard analysis critical control point (HACCP) is applied to the design of pharmaceutical clean air conditioning system. Based on the results of risk assessment, the design process of clean air conditioning systems is summarized. Taking the air volume design of clean air conditioning systems as an example, it is proposed to reserve an air volume control module based on particulate matter concentration in the design stage to provide a new method for energy saving design of clean air conditioning systems under the condition of ensuring controllable risk of contamination in the cleanroom.