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| Risk factors | clean room risks | Impact | Existing control measures | Possibility | Severity | Detectability | Risk Priority Number RPN | Risk Level | Recommended measures |
| high efficiency filter integrity | The high-effICiency filter leaks during leak detection. | Affects the cleanliness of the clean room | Integrity check every year | 2 | 4 | 2 | 16 | medium | The clean room is scanned with a suspended particle counter and confirmed in OQ |
| Air volume and ventilation times | The static environment standard cannot be met within the specified self-Cleaning time, and the particles in the environment cannot be effectively cleaned and replaced. | Increases the risk of microbial contamination | Confirm once a year and monitor wind speed through pressure difference | 2 | 4 | 2 | 16 | medium | Confirmed in OQ |
| Pressure difference | The outside world pollutes the clean room. | Increases the risk of microbial contamination | Install pressure difference gauges in key areas and test room pressure difference | 2 | 4 | 2 | 16 | medium | Check the pressure difference during use and confirm in OQ |
| Temperature and humidity | It affects the comfort and test conditions. | Increases the risk of microbial contamination | Control temperature and humidity through automatic control system, and install temperature and humidity gauges in rooms | 2 | 4 | 2 | 16 | medium | Test the temperature and humidity in the validation OQ, and monitor the temperature and humidity in the room on a daily basis |
| Self-cleaning time | When changing batches during continuous production, the cross-contamination system does not meet the cleanliness Requirements when running. | Contaminates the product | Test once a year | 2 | 4 | 2 | 16 | medium | Confirm the self-cleaning time in the validation OQ |
| Microorganisms | Exceeding the standard | Contaminates the product | Perform daily monitoring | 2 | 4 | 2 | 16 | medium | Confirmed in performance confirmation |
| Cleanliness | Exceeding the standard | Contaminates the product | Perform daily monitoring | 2 | 4 | 2 | 16 | medium | Confirmed in performance confirmation |
What are the bases for cleanroom system risk assessment?
https://www.cleanroomequips.com/Cleanroom-Testing/1924.html
