目录目录.........................................................................................................3第1章胶囊剂工艺设计概述................................................51.1项目概述.........................................................................................................................51.2设计依据.........................................................................................................................51.3设计内容.........................................................................................................................61.4设计指导思想和设计原则.............................................................................................6第2章工艺流程及净化区域划分.................................72.1生产方案、建设规模及包装方式.................................................................................72.1.1生产方案.................................................................................................................72.1.2生产制度.................................................................................................................72.1.3生产规模.................................................................................................................72.1.4胶囊剂的包装.........................................................................................................72.2生产工艺流程.................................................................................................................82.2.1生产工艺流程制定的原则.....................................................................................82.2.2硬胶囊剂的常见生产工艺.....................................................................................82.2.3工艺简介.................................................................................................................92.2.4工艺流程.................................................................................................................112.3胶囊剂洁净区域划分.....................................................................................................122.3.1厂房的洁净级别的划分以及洁净厂房的要求....................................................122.3.2洁净室（区）空气洁净度级别表.........................................................................132.3.3胶囊剂洁净区域划分.............................................................................................13第3章物料衡算.................................................................................143.1物料质量衡算.................................................................................................................143.2胶囊数量计算.................................................................................................................14第4章工艺机械设备选择与说明.............................164.1工艺设备选型的步骤.....................................................................................................164.1.1工艺设备选型依据.................................................................................................164.1.2制药设备GMP设计通则的具体内容.....................................................................164.1.3设备选型说明.........................................................................................................164.2...
