PDA TR26_液体过滤灭菌_Sterilization Filtration Liquids_1998.pdfVIP

液体灭菌过滤 技术报告 No.26 目录 1. INTRODUCTION 简介1 PHARMACEUTICALFILTRATION:HISTORICALHIGHLIGHTS 2. 药用过滤：历史成果 1 3. HOWFILTERSWORK 过滤器如何工作2 3.1SizeExclusion 体积排阻2 3.2 Other Retention Mechanisms其他保留机理2 3.3 BioburdenRetention Probability 生物负荷保留概率2 3.4 Pore SizeRating 孔径大小等级3 4. FILTER SELECTIONAND CHARACTERIZATION 过滤器选择和特点3 4.1Filter Types过滤器类型3 4.2 Filter Configuration 过滤器配置3 4.3 Particle Shedding颗粒脱落4 4.4 Extractable 萃取物4 4.5 ChemicalCompatibility 化学兼容性4 4.6 Adsorption 吸附4 4.7 Thermal StressResistance抗热应力4 4.8 Hydraulic StressResistance抗液压4 4.9 Toxicity Testing 毒性试验4 4.10 Bacterial ChallengeTesting细菌挑战性测试5 4.11PhysicalIntegrity Testing物理完整性测试5 5 PHYSICALANDMECHANICALCHARACTER-ISTICS物理和机械特性5 5.1Filtration Rate andClogging (Throughput)过滤流速和堵塞 （产量）5 5.2 Fluid/Piping 液体/管道6 5.3 Fluid/Filter 液体/过滤器6 5.4 Physicaland StructuralLimitations物理和结构极限6 STERILE FILTERVALIDATION/BACTERIALRE-TENTION 6 无菌过滤器验证/细菌保留 6 6.1FactorsInfluencingMicrobialRetention 影响微生物停留的因素6 Considerationsfor Bacteria1RetentionValidation Studie ... 6.2 细菌停留验证研究需考虑方面 7 6.3 ChallengeOrganism Selection Criteria挑战有机物选择标准7 6.4 CultureMaintenance 培养基保存7 6.5 CultureConditionsand Standardiza