摘要
小试到中试放大过程中的风险是原料药工艺开发人员必须面对的课题。文章将中试工艺风险按单元操作进行了分类,分别对投料反应、物料转移、萃取、检验浓缩、过滤、离心、干燥、粉碎、包装及贮存过程中可能出现的放大问题进行了列举和分析。
The risk of small trial to pilot amplif ication is the subject that API process developers must face.This article classif ied the pilot process risk by unit operation,and listed and analyzed the possible amplif ication problems in feeding reaction,material transfer,extraction,inspection enrichment,f iltration,centrifugal,drying,crushing,packaging and storage.
作者
李健
赵东
LI Jian;ZHAO Dong(Jiangsu Haici Biological Pharmaceutical Co.,Ltd.(Technology Department),Taizhou 225300,China)
出处
《化工管理》
2021年第35期157-158,共2页
Chemical Engineering Management
