CAJ | 학술논문

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。
목적：연구제정일투절실유효、역우조작적제약생산설비무균처리기술，보증분침주사제산품체도무균질량요구。방법이신판GMP위지도，결합생산관리경험，대분침주사제생산중적매태설비、매개구체배절적무균처리기술진행연구。결과규범료분침주사제생산설비적무균처리기술，제정료막과려기、결정관、분쇄궤등관건설비적표준조작규범。결론이용저투무균처리기술，재엄격집행표준조작적정황하，능구보증설비체도산품생산적무균질량요구。
Objective To formulate a set of practical and easy to operate aseptic processing technology of pharmaceu -tical production equipment to ensure powder injection productions meets quality requirements .Methods Each de-vice 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 equip-ments such as the membrane filter ,the crystallization tank ,and operating standards grinder were established .Conclu-sion 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 .