2气体过滤器原理与应用.pdf

Principles Applications of Gas Filters 气体过滤器的原理及应用 过滤/完整性测试培训课程 What you will learn 主要内容 • Gas filter criteria 气体过滤器的标准 • Typical gas filter applications in BioPharm manufacturing 在生物制药中的气体过滤器的典型应用 • How gas filters work 气体过滤器工作原理 • How gas filter ratings differ from liquid filters 气体过滤器与液体过滤器孔径标定的不同 • Other considerations for gas filter sizing and use 在气体过滤器设计及使用时需要考虑的一些问题 Criteria for Gas Filters 气体过滤器的标准 • Organism retentive either wet or dry 在湿润及干躁状态下的微生物截留 • Integrity testable 可以进行完整性测试 • Resistant to repeated in-situ steam sterilization 重复在线蒸气灭菌的能力 • Inherently hydrophobic 天然的疏水性 • Non-fiber releasing if in contact with final product 在接触最终产品时没有纤维脱落 • Simple to service and maintain 售后服务及维修比较简单 • Have a low initial and final pressure drop 低的最初及最终的压降 • Comply with G.M.P. guidelines 符合GMP规范 Typical Venting Applications 典型的呼吸器应用 • Sterile Containers (Carboys)无菌容器(玻璃瓶) • Product Storage or Holding Tanks产品储罐 • Freeze Dryers (Lyophilizers), Autoclaves冻干机,灭菌釜 Typical Fermentation Applications 典型的发酵应用 • Inlet (Sparge gas)进口(喷射气体) • Exhaust (Stack gas)排气 • Exhaust gas issues 排气问题 – Gas is saturated with water – 气体中含有饱和水 – Aerosolized microorganisms are present at high concentration – 雾化的微生物浓度高 – Need a sterilizing grade filter – 需要除菌级过滤器 Typical Facilities Applications 典型的公用设施应用