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微生物污染控制策略在无菌注射剂生产中的验证与优化

Validation and optimization of microbial contamination control strategies in the production of sterile injections

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目的 本研究旨在验证并优化无菌注射剂生产过程中的微生物污染控制策略,以确保产品安全、提升生产质量.方法 采用随机试验设计,于 2022 年 1 月至 2023 年 12 月期间进行研究,2022 年 1 月至 2022 年 12 月之间采用传统控制策略,2023 年 1 月至 2023 年 12 月之间采用优化后策略.通过对比不同策略下的微生物污染情况,结合生产环境监控、工艺流程分析以及操作员行为规范评估,综合评估控制策略的有效性,并针对性地进行策略优化.结果 研究发现,与优化前相比,优化后的策略使得产品微生物污染风险大幅减少,提高了生产效率和产品质量.结论 验证与优化后的微生物污染控制策略在无菌注射剂生产中具有显著效果,为确保注射剂产品的无菌性和安全性提供了有力保障.未来,将持续监控生产过程,并根据实际情况对控制策略进行动态调整,以适应不断变化的生产环境和法规要求.
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 injectionmicrobial contaminationcontrol strategy

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齐鲁制药有限公司,济南 250098

无菌注射剂 微生物污染 控制策略

2024

实验室检验
中国检验检测学会

实验室检验

ISSN:2097-261X
年,卷(期):2024.2(5)
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