The environmental conditions of the clean room directly affect the quality of products. The environmental control process is the fundamental guarantee to realize the clean room for the production of medical devices and is one of the key links to ensure the quality of products. Through the daily monitoring of the personnel, equipment and logistics in the clean room, the maintenance of the air purification system, and the statistics and trend analysis of the collected relevant data, to verify whether the environmental control process can stably meet the requirements of the production process.