摘 要：
本研究针对高活性药物（HAPs）生产特性与风险，提出隔离器集成化药厂布局优化方案。通过模块化隔离单元设计、物流与人员流动动态模拟及智能化监控系统集成应用，实现生产安全性、效率与灵活性提升。研究采用“层流罩+隔离器”复合结构缩小核心操作区，利用SLP方法优化物流路径，结合物联网与AI算法实时监控环境参数。实证研究表明，优化后单批次生产时间缩短28%，环境监测合格率提升至99.97%，且满足ICH Q9质量风险管理要求。未来将探索AI驱动自适应布局与数字孪生技术，推动布局优化向数据驱动转型。
关键词：高活性药物生产；集成化药厂；物联网
Abstract:
Highly active substances (HAPs) pose extremely high requirements for isolation and pollution control during the production process due to their significant biological effects and strong toxicity. The traditional cleanroom layout relies on air filtration and laminar flow technology, but it is difficult to completely isolate the tiny particles and aerosols of HAPs, and there are problems such as high construction and operation costs and great difficulty in protecting operators. Isolator technology achieves complete isolation of the production area from the outside world through physical barriers, becoming the key to reconfiguring the production space and enhancing safety and efficiency. However, in actual operation, isolator integrated pharmaceutical factories are confronted with challenges such as equipment redundancy, inefficient logistics routes, and insufficient human-machine collaboration, which restrict the further improvement of production efficiency and safety. This research aims to optimize the integrated layout of isolators in pharmaceutical factories through scientific and reasonable spatial planning, process flow design and personnel operation management, and to address the limitations of traditional layouts. The research first analyzed the production characteristics and risks of highly active drugs and identified the shortcomings of the traditional cleanroom layout. Subsequently, the design principles of modular isolation units, the dynamic simulation methods of logistics and personnel flow, and the integrated application strategies of intelligent monitoring systems were proposed; Through empirical research and effect verification, it has been proved that the optimization plan has significant effects in improving production efficiency, reducing pollution risks and lowering operating costs. Finally, the future research directions were prospected, including the application of AI-driven adaptive layout adjustment systems and digital twin technology, to promote the transformation and upgrading of the high-activity drug production industry.
Keywords: Production of highly active drugs; Integrated pharmaceutical factory; Internet of things
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