Millpore 7 - Risk Assessment of Filters in Aseptic Processes英文资料.pdfVIP

Risk Assessment of Filters in Aseptic Processes Module 8 Copyright Merck Millipore 2011. 1 Regulatory Aspects法规事务 Aseptic Processing Risks无菌工艺风险 Filter Categories 过滤器种类 Some Risk Assessment Tools风险评估工具 Examples of 2 Typical Schematics典型图表案例 Definitions定义 Sterilizing filter reuse in aseptic processing References参考 Copyright Merck Millipore 2011. 2 Aseptic Processing - Risk-Based Approach 无菌工艺-基于风险的方法 Aseptic Processing requires “A strict design regime, not only on the process area, but on the interactions with surrounding areas and the movement of people, materials and equipment so as not to compromise the aseptic conditions.”无菌工 艺要求“严格的设计制度，不仅限于工艺本身，还包括与周围环境和人员活动，材料 和设备，以免破坏无菌的环境” – [ISPE Sterile Manufacturing Facilities Guide, Volume 3, January 1999] ISPE无菌生产设备指南 “Each process could introduce an error that ultimately could lead to the distribution of a contaminated product. Any manual or mechanical manipulation of the sterilized drug, components, containers, or closures prior to or during aseptic assembly poses the risk of contamination and thus necessitates careful control.”“ 每个过程都有可能生成导致产品污染的差错。任何无菌药品、容器的手动或机械操 作，或无菌安装前或安装时可能产生的任何染污风险必须严格控制” – Technical Framework: FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 2004 FDA指南关于无菌工艺工业化生产无菌药品 Copyright Merck Millipore 2011.