粉针注射剂生产设备的无菌处理技术研究  

Study on aseptic processing technology of powder injection production equipment

作　　者：单松波[1] 

机构地区：[1]漳州卫生职业学院,福建漳州361021

出　　处：《吉林医药学院学报》2014年第4期257-259,共3页Journal of Jilin Medical University

摘　　要：目的研究制定一套切实有效、易于操作的制药生产设备无菌处理技术,保证粉针注射剂产品达到无菌质量要求。方法以新版GMP为指导,结合生产管理经验,对粉针注射剂生产中的每台设备、每个具体环节的无菌处理技术进行研究。结果规范了粉针注射剂生产设备的无菌处理技术,制定了膜过滤器、结晶罐、粉碎机等关键设备的标准操作规范。结论利用这套无菌处理技术,在严格执行标准操作的情况下,能够保证设备达到产品生产的无菌质量要求。Objective To formulate a set of practical and easy to operate aseptic processing technology of pharmaceutical production equipment to ensure powder injection productions meets quality requirements .Methods Each device and each specific aspects of aseptic processing technology in powder injection production were studied under the guidance of new GMP standards combined with production management experiences .Results The aseptic processing technology of powder injection production equipments were standardized; standard operating procedure of key equipments such as the membrane filter ,the crystallization tank ,and operating standards grinder were established .Conclusion Practice has proved that powder injection product meet sterile quality requirements , because the product is made by this set of aseptic processing technology in the strict operating conditions .

关 键 词：粉针注射剂 新版GMP 制药生产设备 无菌处理技术 

分 类 号：TQ460.8[化学工程—制药化工]