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RECOMMENDATION ON TH....... ...... 7
Test Performance测试性能............................................................................ 7
Selection of Growth Medium培养基的选择............................................. 7
Incubation Conditions培养条件 ..................................................................... 8
Reading of the Test测试的读取 ......................................................................8
Test Frequency 测试频率.............................................................................. 8
6. INTERPRETATION OF DATA数据的判定....................................................... 9
7. ENVIRONMENTAL AND PERSONNEL MONITORING环境和人员的监测.....10
Air Borne Microbial and Non-Viable Particle Monitoring............................ 10
浮游菌和尘埃粒子的监测
Non-viable monitoring................................................................ ................. 10
Microbial Monitoring微生物监控..................................................................... 10
Intervention Monitoring对干扰的监测 ..............................................................11
8. STAFF TRAINING人员培训............................................................................... 11
9. IMPORTANT FACTORS IN VALIDATION OF ASEPTIC
MANUFACTURING无菌生产验证中的关键因素......................................................12
Container/Closure Integrity Testing容器/密封件的完整性测试............................. 12
Container/Closure Sterilisation容器/密封件的灭菌 ............................................ 12
Equipment Cleaning and Sterilisation设备清洁和灭菌 .................................... 13
Disinfection消毒............................................................................................... 13
Filter Validation过滤器验证............................................................................... 14
Vent Filters呼吸器 ......................