制藥工廠(chǎng)設(shè)計(jì)作業(yè)

1、設(shè)計(jì)說(shuō)明書(shū)1目錄第一章總述................................................................................................................................21.1設(shè)計(jì)題目.......................................................................

2、.....................................................21.1.1原料藥多功能車(chē)間.................................................................................................21.2設(shè)計(jì)依據(jù)................................................

3、............................................................................21.3產(chǎn)品介紹............................................................................................................................21.3.1硫辛酸...

4、..................................................................................................................21.3.2依非韋倫................................................................................................

5、.................21.3.3纈沙坦.....................................................................................................................31.4產(chǎn)品的組合方案..................................................................

6、..............................................3第二章工藝說(shuō)明............................................................................................................................4.1生產(chǎn)方法...................................

7、...........................................................................................42.1.1工藝路線(xiàn).................................................................................................................42.1.2

8、工藝方框流程圖.....................................................................................................4第三章主要工藝設(shè)備選擇....................................................................................................

9、.........83.1概述....................................................................................................................................83.2設(shè)備選擇.................................................................

10、...........................................................9第四章車(chē)間布置..........................................................................................................................144.1車(chē)間布置......................

11、....................................................................................................144.1.1車(chē)間布置原則........................................................................................................144

12、.1.2車(chē)間布置說(shuō)明........................................................................................................15第五章GMP專(zhuān)篇................................................................................................

13、.........................165.1潔凈區(qū)劃分和空氣結(jié)晶等級(jí)說(shuō)明...................................................................................165.1.1規(guī)定....................................................................................

14、...................................165.1.2車(chē)間潔凈分區(qū)圖....................................................................................................175.1.3空氣潔凈等級(jí)..........................................................

15、.............................................17設(shè)計(jì)說(shuō)明書(shū)331.3.2.2產(chǎn)品規(guī)格產(chǎn)品規(guī)格白色晶體，含量99.5%?；瘜W(xué)結(jié)構(gòu)式：分子式：C14H9ClF3NO2分子量：315.681.3.3纈沙坦纈沙坦1.3.3.1產(chǎn)品名稱(chēng)及生產(chǎn)規(guī)模產(chǎn)品名稱(chēng)及生產(chǎn)規(guī)模產(chǎn)品名稱(chēng)：纈沙坦英文名稱(chēng)：Valsartan生產(chǎn)規(guī)模：25ta1.3.3.2產(chǎn)品規(guī)格產(chǎn)品規(guī)格白色結(jié)晶體，含量99.5%?；瘜W(xué)結(jié)構(gòu)式：分子式：

16、C24H29N5O3分子量：435.521.4.4產(chǎn)品的組合方案產(chǎn)品的組合方案多功能車(chē)間先生產(chǎn)硫辛酸，投一批硫辛酸原輔料，固定時(shí)間27.25小時(shí)，可調(diào)整時(shí)間14.440小時(shí)，共需41.690小時(shí)，圓整到45小時(shí)生產(chǎn)出精品，一共投料55次，共需2475小時(shí)，折合成104天。其次，生產(chǎn)依非韋倫，投一批依非韋倫原輔料，固定時(shí)間35.43小時(shí)，可調(diào)整時(shí)間11.020小時(shí)，共需46.450小時(shí)，圓整到50小時(shí)生產(chǎn)出精品，一共投料55次，共需275