大容量注射剂生产中不溶性微粒的控制  

Control of insoluble particles in large volume injections

作　　者：郑光辉 Zheng Guanghui(Guangdong Yi Xiang Pharmaceutical Co.,Ltd,Guangzhou 511325)

机构地区：[1]广东怡翔制药有限公司,广东广州511325

出　　处：《化工与医药工程》2020年第1期39-41,共3页Chemical and Pharmaceutical Engineering

摘　　要：从基于风险评估的理念,遵循质量源于设计的原则入手,通过在生产过程中优化生产工艺,减少生产环节对产品的污染,引进国际先进技术和先进标准,不断调整和完善公司的质量体系,不断提升公司的技术创新能力及产品质量,加强关键区域人员数量控制,优化洁净区操作,通过上述的管理控制以达到最大限度降低产品不溶性微粒的管理目标。Based on the philosophy of risk appraise and from the point of quality resulted from design,it was described that with the optimization of productive process,reduction of contamination in production,introducing advantageous technology from abroad,the quality control system,technical innovation ability and product quality of the company ban be enhanced continuously.The target of reducing insolvable particles in the product with the maximum limit can be reached with the managements,such as the control of personal number in sensitive area and the optimization of the operation in cleaning area.

关 键 词：大容量注射剂 微粒 控制 风险 

分 类 号：TQ460.6[化学工程—制药化工]