PDA：Aseptic_Processing无菌加工（2023年修订版中文翻译）-195页

目录
Introduction简介 6
Glossary 术语表 9
I Physical Environment 物理环境 16
Topic A.1: Airflow Velocity 主题A.1:风速 17

Topic A.2: Airflow Velocity Measurements主题 A.2:风速测量 19

Topic A.3: Airflow Velocity Measurement Frequency 主题 A.3:风速测量频率 21

Topic B.1: Airflow Visualization主题 B.1:气流可视化 23

Topic B.2: Airflow Visualization Recording 主题B.2:气流可视化记录 26

Topic C: Grade A Environment Over Cappers 主题C:轧盖机A级环境 28

Topic D: Differential Pressure主题 D:压差 30

Topic E: Testing of HEPA Filters主题 E:高效过滤器的测试 33

Topic F: HEPA Filter Patching主题 F:高效过滤器修补 35

Topic G: Laminar Versus Unidirectional Airflow 主题 G:层流与单向流 38

Topic H: Length and Radii of Airborne Sampling Tubing 主题 H:空气采样管的长度和半径 40

Topic I: RABS and Isolators—Aseptic Processing Technologies 主题 I:RABS 和隔离器--无菌加工技术 42

Topic J: Environmental Clean-Up Period Determination (at Rest) 主题J:环境自净时间的确定(静态) 48

Topic K.1: Blow-Fill-Seal Process Design and Operation 主题 K.1:吹-灌-封工艺的设计与操作 50

Topic K.2: Plastic Resin Storage and Handling 主题K.2:塑料树脂的储存和处理 53

Topic K.3: Blow-Fill-Seal Process Simulation 主题K.3:吹-灌-封工艺模拟 55

Topic L: Air Locks主题L:气锁 57

Topic M: “At-Rest” and “In-Operation” Status 主题M:“静态”和“动态” 59

Topic N: Sample Volume for Classification 主题N:级别确定的采样体积 61

Topic O: ≥0.5 μm and ≥5 μm Total Particle Monitoring 主题O: ≥0.5 μm 和 ≥5 μm总颗粒的监测 62

II Environmental Monitoring环境监测 64

Topic A.1: Setting Alert Levels and Action Limits 主题A.1:警戒限和行动限设置 65

Topic B.1: Environmental Monitoring Alert and Action Limits 主题B.1: 环境监测警戒限和行动限 68

Topic C: Environmental Monitoring—Relationship to Batch Release 主题C:环境监测与批放行的关系 70

Topic D: Location, Frequency, and Duration of Viable and Total Particulate Monitoring 主题D:活性粒子和总粒子监测的位置、频率和持续时间 72

Topic E: Investigation and Documentation of Environmental Monitoring Excursions 主题E:环境监测超标的调查和记录 76

Topic F: Rooms Classification/Zoning for Terminally Sterilized Solution Products 主题F:最终灭菌溶液产品的房间分级/分区 78

Topic G: Cleaning and Disinfection Program for Grade A and Grade B Rooms 主题 G:A 级和 B 级房间的清洁和消毒程序 81

Topic H: Identification of Environmental Isolates 主题 H:环境分离菌的鉴定 84

Topic I: Growth-Promotion Testing of Environmental Monitoring Media 主题 I: 环境监测培养基的促生Points to Consider No 1:Aseptic Processing (Revised 2023)长试验 87

Topic J: Incubation Temperatures for Environmental Monitoring Samples 主题 J:环境监测样品的培养温度 89

III Validation(Aseptic Process Simulation) 验证(无菌工艺模拟)91

Topic A: Acceptance Criteria主题 A:可接受标准 92

Topic B: Duration of Process Simulations versus Production 主题 B:无菌工艺模拟与生产的持续时间 95

Topic C: Incubation Temperatures主题C:培养温度 98

Topic D: Incubation of Nonintegral and Rejected Units 主题 D:未密封和被剔除单元的培养 100

Topic E: Aseptic Process Simulation Reconciliation 主题 E:无菌工艺模拟数量的平衡 103

Topic F: Inverting Units Prior to or During Incubation 主题 F:培养前或培养过程中的单位翻转105

Topic G: Aerobic versus Anaerobic主题G:需氧与厌氧 107

Topic H: Aseptic Process Simulation Boundaries 主题H:无菌工艺模拟界限 109

Topic I: Fill Volume主题I:灌装体积 111

Topic J: Interventions — Type and Frequency 主题J:干预-类型和频率 112

Topic K: Video Recording 主题K:录像 115

Topic L: Invalidated or Aborted Aseptic Process Simulation 主题L: 无效或终止的无菌工艺模拟 117

Topic M: Number of Aseptic Process Simulation Tests Required 主题 M:无菌工艺模拟试验需要的次数 119

Topic N: Infrequently Used Lines主题N:不常用的生产线 122

Topic O: Special Considerations for Aseptic Process Simulation in Isolators and Other Advanced AsepticProcesses 主题 O:隔离器和其他先进无菌工艺中无菌工艺模拟的特殊考虑因素124

Topic P: Hold Times for Sterile Bulk 主题 P:无菌原液的保持时间 126

IV Personnel 人员 128
Topic A: Glove Monitoring主题A:手套监测 129

Topic B: Aseptic Personnel Qualification Program 主题 B:无菌人员资格确认程序132

Topic C: Aseptic Processing Area Access Control 主题C:无菌加工区进出控制 141

Topic D: Performance of Environmental Monitoring 主题D:环境监测的执行 143

Topic E: Supervision in the Aseptic Processing Area 主题E:无菌加工区的监管 145

Topic F: Personnel Monitoring Frequency and Location 主题F:人员监控的频次和位置 147

Topic G: Sterile Gown Usage 主题G:无菌洁净服的使用 150

Topic H: Occupancy in the Aseptic Processing Area 主题H:无菌加工区域的使用时间 151

Topic I: Personnel Practices for Hygiene and Hand Washing 主题I:人员卫生和洗手规范 153

V Material Transfer 物料转运 155

Topic A: Entry of Equipment and Material into an Aseptic Processing Area 主题 A:设备和材料进入无菌生产区 156

Topic B: Sterile Hold Times for Materials 主题 B:材料的无菌保存时间 158

VI Cleaning, Disinfection, and Sterilization 清洁、消毒和灭菌 160

Topic A: Disinfection Program 主题 A:消毒程序 161

Topic B: Sterilization of Sanitizers, Disinfectants, and Cleaning Agents 主题 B:杀菌剂、消毒剂和清洁剂的灭菌法 164

Points to Consider No 1:Aseptic Processing (Revised 2023)

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Topic C: Hold Times for Sterilized Wrapped Parts, Components, and Other Material 主题 C:无菌包装部件、组件和其他材料的保持时间 166

Topic D: Frequency of Requalification of Sterilization Processes 主题D:灭菌工艺再确认频率 168

Topic E:Porous/Hard Goods Sterilization Process Qualification 主题E:多孔/硬质物品灭菌工艺确认.171

Topic F: Integrity Testing of 0.2 Micron Filters 主题F:0.2微米过滤器的完整性测试173

Topic G: Sterilization – Steam Sterilizers 主题G:灭菌-蒸汽灭菌器 175

Topic H: Lyophilizer Leak Qualification 主题H:冻干机泄露确认 179

Topic I: Sterilizing Grade Gas or Vent Filter Integrity Testing 主题I:气体除菌过滤器或通气过滤器完整性测试 182

Topic J: Pre-Use, Post-Sterilization Integrity Test of Sterilizing Filters 主题 J: 除菌过滤器使用前和灭菌后的完整性测试 184

Topic K: Integrity Testing of Sterilizing Filters 主题 K: 除菌过滤器的完整性测试 188

Topic L: Use of Two Sterilizing-Grade Filters for Product Sterile Filtration 主题 L: 使用两个除菌级过滤器进行产品除菌过滤 190

VII Critical Utilities 关键公用设施 192

Topic A: Methods of Production Requirements for Water for Injection 主题 A: 注射用水的生产方法要求 193

Topic B: Requirements for Water for Injection 主题 B: 对注射用水的要求 195