符合新版GMP的无菌粉体密闭转移--闫永辉奥星集团2012.4.17.pdf

16th – 17th April 2012, Beijing Contained sterile powder handling solution conforming to new GMP. 符合新版符合新版GMP的无菌粉体密闭转移的无菌粉体密闭转移 闫永辉 奥星集团  Appendix of sterile drugs being amended in new versiion GMPGMP 新版GMP无菌药附录重点  Sterile API Transfering 无菌粉体转运方案  Sterile API Filling 无菌原料药分装方案  Case study 案例分析 新版GMP重点修订了无菌药品附录 AppendixAppendix ofof sterilesterile drugsdrugs beingbeing amendedamended inin newnew versionversion GMPGMP  采用了欧盟和WHO 的A 、B、C、D分级标准  EU and WHO standards for A, B, C, and D classification are adopted  对无菌药品生产的洁净度级别提出了非常具体的要求  Very specific requirements for cleanliness level of sterile drugs production are put forwardforward.  悬浮粒子的静态、动态监测  Static and dynamic testing of airborne particles  浮游菌浮游菌、、沉降菌和表面微生物的检测沉降菌和表面微生物的检测  Testing of planktonic bacteria, sedimentated bacteria, and surface microbe  细化了培养基模拟灌装、灭菌验证和管理的要求  More detailed requirements are put forward for simulated filling of culture media, stteriliilizatition validlidatition, andd managementt;  增加了无菌操作的具体要求  Specific requirements for sterile operation are added;  强化了无菌保证的措施强化了无菌保证的措施  Measures for sterility assurance are strengthened. 非最终灭菌产品严格 Non- finally sterilized products 洁净度级别 非最终灭菌产品的无菌生产示例 Cleanliness Example of sterile production for non-finally sterilized products class B级背景下的A级 处于未完全密封(1)状态下产品的操作和转运，如产品灌装（或灌封）、分装、压塞、轧盖 Class A under (2)等 Class B Operation and transferring under not fully sealed state (1), such as product filling (or filling backgroundbackground andand sealing)sealing), fillingfilling, stopp