Objective Therefore, the purpose of this study is to verify and optimize the microbial contamination control strategies during the production of sterile injections to ensure product safety and improve production quality. Methods A randomized trial design was conducted between January 2022 and December 2023, a traditional control strategy between January 2022 and December 2022, and a post-optimized strategy between January 2023 and December 2023. By comparing the microbial pollution under different strategies, combining with the production environment monitoring, process process analysis and operator behavior code assessment, the effectiveness of the control strategy is comprehensively evaluated, and the strategy is optimized. Results The study found that the optimized strategy greatly reduced the risk of microbial contamination and improved production efficiency and product quality. Conclusion The validation and optimized microbial contamination control strategy has significant results in the production of sterile injection, which provides a strong guarantee to ensure the sterility and safety of the injection products. In the future, the production process will be continuously monitored, and the control strategy will be dynamically adjusted according to the actual situation to meet the changing production environment and regulatory requirements.

sterile injection  /  microbial contamination  /  control strategy