RABS共1篇
202505-PDA-Sterility Assurance – Meeting an Industry Unmet Technical Need on Design and Operation of Restricted Access Barrier Systems (RABS)制药行业RABS设计与操作:满足未满足的无菌保障技术需求-附下载-药研库

202505-PDA-Sterility Assurance – Meeting an Industry Unmet Technical Need on Design and Operation of Restricted Access Barrier Systems (RABS)制药行业RABS设计与操作:满足未满足的无菌保障技术需求-附下载

一、RABS 的行业定位:介于隔离器与传统工艺之间的优化选择 与隔离器相比,RABS 虽因无法实现完全密闭的自动化生物去污流程,产品污染风险相对略高,但相比传统的帷幕式工作台无菌工艺,其防...