瑞舒伐他汀钙说明书——最终修改版（姜邵乙）

本资料包含pdf文件1个，下载需要1积分

瑞舒伐他汀钙说明书——最终修改版（姜邵乙）
目录
前言.........................................................................1
1 设计依据及规模 ............................................................2
1.1 设计依据...............................................................2
1.2 设计规模...............................................................2
1.3 产品介绍...............................................................3
1.4 设计原则...............................................................3
1.5 设计范围...............................................................4
1.6 设计思路...............................................................5
2 工艺说明 ..................................................................6
2.1 工艺路线...............................................................6
2.2 工艺流程图.............................................................6
2.3 工艺流程详述...........................................................7
3 生产制度 ..................................................................8
3.1 生产方式及时间.........................................................8
3.2 生产班制...............................................................8
3.3 生产周期...............................................................8
3.4 生产包装...............................................................8
4 物料衡算 ..................................................................9
4.1 物料衡算的工艺条件.....................................................9
4.2 物料衡算的基准.........................................................9
4.3 物料衡算过程..........................................................10
5 工艺设备选择 .............................................................16
5.1 设备选型原则..........................................................16
5.2 设备选型..............................................................16
5.3 设备选型一览表........................................................24
6 车间布置 .................................................................25
6.1 车间布置依据..........................................................25
6.2 车间布置原则..........................................................25
6.3 车间布置说明..........................................................26
6.4 车间布置总述..........................................................27
6.5 厂址选择..............................................................27
7 工艺专业执行行政法规措施 .................................................28
7.1 消防设计措施..........................................................28
7.1.1 消防设计依据......................................................28
7.1.2 防火措施..........................................................28
7.1.3 防爆措施..........................................................28
7.1.4 安全疏散措施......................................................28
7.2 环境保护措施..........................................................29
7.2.1 环境保护概述......................................................29
7.2.2 药品生产中对“三废”的处理........................................29
7.2.3 噪音污染的控制措施................................................29
7.2.4 粉尘污染的控制措施................................................29
7.3 劳动安全卫生措施......................................................30
7.4 节能措施..............................................................30
8 GMP 符合性说明 ............................................................31
8.1 洁净区划分和空气洁净等级说明..........................................31
8.2 车间人流物流流向说明..................................................31
8.3 空调系统、除尘及排风系统设置要求 ......................................32
8.3.1 室内温湿度........................................................32
8.3.2 气流要求..........................................................32
8.3.3 除尘及局部排风设置要求............................................32
8.4 洁净室装修要求........................................................32
8.5 工艺设备选型说明......................................................33
8.6 洁净公用工程设施设置说明..............................................33
9 存在问题及建议 ...........................................................34
9.1 存在问题..............................................................34
9.2 设计感悟..............................................................34
参考文献 ...................................................................35
附录 .......................................................................36
附录 1：瑞舒伐他汀钙胶囊剂设备选型一览表 ..................................36
附录 2：瑞舒伐他汀钙胶囊剂车间工艺流程简图 ................................36
附录 3：瑞舒伐他汀钙胶囊剂车间工艺设备平面布置图 ..........................36