原料药制造过程“三废”排放量大,使制药行业面临严峻的环保问题挑战。践行绿色制药理念,发展和应用清洁生产技术,从工艺源头减少污染物排放是实现绿色制药的核心和关键。以技术可达、成本最低为原则,以制造过程污染源解析为基础,将清洁生产、废弃物资源化利用和无害化处理相结合,制定基于全生命周期的制药全过程污染控制策略。以该策略为指导,重点突破与实施减排控污关键技术和集成技术,树立精准控制与最优化的管理理念,实现原料药制造从质量效益型向质量可控、资源节约型转变,支撑制药行业可持续绿色发展。
<<The manufacturing process of APIs created a large amount of “three wastes”,which put the pharmaceutical companies to confront serious environmental protection challenges. Practicing the concept of green pharmaceuticals,developing and applying clean production technologies,and reducing pollutant emissions from the source of the process were the core and key to green pharmaceuticals. In line with the principle of technology accessibility and lowest cost,based on the analysis of pollution sources in the manufacturing process,clean production,reclamation of wastes and harmless treatment were combined to formulate a whole process pollution control strategy for the whole life cycle of pharmaceutical manufacturing. Guided by this strategy,the efforts were put on breakthroughs and implementation of key technologies and integrated technologies for emission reduction and pollution control,to establish a management concept of precise control and optimization,realize the transformation of API manufacturing from quality and efficiency oriented to quality control and resource conservation oriented,and support the sustainable green development of the pharmaceutical industry.
<<Keywords: | Green PharmaceuticalsAPI ManufacturingWhole Process Pollution ControlReclamation of WastesPollution Control. |