PDA TR26 液体过滤灭菌

液体灭菌过滤

技术报告

No. 26

目录

1.

INTRODUCTION

简介

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2.

PHARMACEUTICAL FILTRATION: HISTORICAL HIGHLIGHTS

药用过滤：历史成果

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3.

HOW FILTERS WORK

过滤器如何工作

.

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3.1

Size Exclusion

体积排阻

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3.2

Other Retention Mechanisms

其他保留机理

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3.3

Bioburden Retention Probability

生物负荷保留概率

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3.4

Pore Size Rating

孔径大小等级

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4.

FILTER SELECTION AND CHARACTERIZATION

过滤器选择和特点

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3

4.1

Filter Types

过滤器类型

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4.2

Filter Configuration

过滤器配置

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4.3

Particle Shedding

颗粒脱落

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4.4

Extractable

萃取物

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4.5

Chemical Compatibility

化学兼容性

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4.6

Adsorption

吸附

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4.7

Thermal Stress Resistance

抗热应力

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4.8

Hydraulic Stress Resistance

抗液压

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4.9

Toxicity Testing

毒性试验

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4.10

Bacterial Challenge Testing

细菌挑战性测试

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4.11 .......... .................................................. .................................................. .........................

Physical

Integrity Testing

物理完整性测试

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5

PHYSICAL AND MECHANICAL CHARACTER- ISTICS

物理和机械特性

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5

5.1

Filtration Rate and Clogging (Throughput)

过滤流速和堵塞（产量）

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5.2

Fluid/Piping

液体

/

管道

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5.3

Fluid/Filter

液体

/

过滤器

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5.4

Physical and Structural Limitations

物理和结构极限

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6

STERILE FILTER VALIDATION/BACTERIAL RE- TENTION

无菌过滤器验证

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细 菌保留

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6.1

Factors Influencing Microbial Retention

影响微生物停留的因素

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6.2

Considerations for Bacteria1 Retention Validation Studie

细菌停留验证研究需考虑方面

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6.3

Challenge Organism Selection Criteria

挑战有机物选择标准

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6.4

Culture Maintenance

培养基保存

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6.5

Culture Conditions and Standardizatio

培养基状况和标准

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6.6

Effective Challenge Concentration

有效挑战浓度

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6.7

Challenge Level

挑战等级

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6.8

Aggregation

聚合

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6.9

Culture Viability

培养基存活能力

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6.10

Challenge Test Methods

挑战性测试方法

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6.11

Test Organism Viability

测试有机物存活能力

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6.12

Testing Procedure and Protocol Development

测试程序和方案起草

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6.13

Nonbactericidal Processes and Fluids

无菌工艺和液体

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6.14

Surrogate Fluids

替代液体

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6.15

Bacteriostatic/Bactericidal/Nondispersive Challenge Fluids

细菌抑制

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灭菌

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非分散挑战

液体

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