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摘  要

依據(jù)于麗珠集團(tuán)福州福興醫(yī)藥有限公司的發(fā)酵車間實(shí)際情況，設(shè)計(jì)了平均效價(jià)為500000IU/ml，年產(chǎn)為一百萬(wàn)十億（IU）粘桿菌素發(fā)酵車間。在設(shè)計(jì)中采用了機(jī)械攪拌通風(fēng)式發(fā)酵罐、間歇流加法補(bǔ)糖和補(bǔ)氨及符合GMP制藥車間作業(yè)規(guī)范。進(jìn)行了：工藝設(shè)計(jì)、車間設(shè)計(jì)、車間圖紙的繪制、生物反應(yīng)器的設(shè)計(jì)及物料和能量衡算等。

關(guān)鍵詞：粘桿菌素；發(fā)酵車間；設(shè)計(jì)。

Design a fermentative workshop of Colistin with annual production million billion (IU)

Abstract

According to the LiZhu group FuXing fuzhou pharmaceutical Co., LTD. of fermentation workshop actual situation，The average potency unit for design is 500000IU/ml，annual production million billion (IU) with colistin fermentative workshop. In the design use the mechanical ventilated motor fermentor、intermittent flow additive for sugar and ammonia water and in accordance with GMP pharmaceutical workshop working standard. The design specification contains:process design, shop drawings, workshop design drawing, biological reactor design and material and energy balance and so on.

Key words：Colistin; fermentative workshop；design.

目錄

第1章  緒論

1.1 粘桿菌素工廠簡(jiǎn)介········································· 1

1.2 概況····················································· 1

1.3 課題意義及設(shè)計(jì)內(nèi)容······································· 2

第2章  工藝設(shè)計(jì)

2.1 產(chǎn)品概述················································· 3

2.2 產(chǎn)品標(biāo)準(zhǔn)················································· 3

2.2.1 獸用質(zhì)量標(biāo)準(zhǔn)··········································· 3

2.2.2  EP4質(zhì)量標(biāo)準(zhǔn)··········································  3

2.2.3  原材料質(zhì)量規(guī)格········································ 4

2.2.4  生產(chǎn)培養(yǎng)基配方········································ 5

2.2.5  GMP對(duì)發(fā)酵車間作業(yè)要求································· 5

2.2.5.1清潔衛(wèi)生標(biāo)準(zhǔn)操作規(guī)程····························· 5

2.2.5.2 種子罐工序·········································· 6

2.2.5.3發(fā)酵罐工序··········································· 7

2.3 工藝流程設(shè)計(jì)············································· 10

2.3.1  工藝概述及原則········································ 10

2.3.2  操作流程··············································· 10

2.3.3  發(fā)酵工藝流程··········································· 11

2.3.4  操作工時(shí)與生產(chǎn)周·········································  11

2.3.5發(fā)酵工藝控制  ····································  11

2.3.6  生產(chǎn)工藝流程圖···········································  11

2.3.7  培養(yǎng)工程一覽表·········································  12

第3章 車間設(shè)計(jì)

3.1 菌種選育車間············································  13

3.2  配料車間···············································  13

3.3.1  發(fā)酵車間·············································  13

3.3.1.1  機(jī)械攪拌通風(fēng)發(fā)酵罐·································· 13

3.3.1.2  蒸汽系統(tǒng)············································ 14

3.3.1.3  冷卻系統(tǒng)··········································· 14

3.3.1.4  DCS控制中心·······································  15

3.4  發(fā)酵車間布置··········································  15

3.4.1  整體布置············································  15

3.4.2  平面布置············································  15

3.4.3  設(shè)備布置···········································   15

3.4.4  管道布置···········································   16

第4章  物料衡算及能量衡算

4.1 物料衡算··············································   17

4.2 能量衡算··············································  18

4.2.1  水平衡計(jì)算·········································  22

4.2.2  蒸汽耗量計(jì)算········································· 22

4.2.3  無(wú)菌壓縮空氣消耗量計(jì)算································· 23

第5章  設(shè)備選型及其計(jì)算

5.1 主要生產(chǎn)設(shè)備選型及其計(jì)算··································· 24

5.1.1 發(fā)酵罐設(shè)計(jì)············································  24

5.1.2 種子罐設(shè)計(jì)············································  28

5.2  空氣分過(guò)濾器設(shè)計(jì)·········································  33

5.3  空氣站空壓機(jī)選擇········································  34

5.3 設(shè)備清單··················································  34

5.4 總廠平面設(shè)計(jì)··············································  35

5.4.1  總平面設(shè)計(jì)的原則和要求·································  35

5.4.2  廠區(qū)組成與劃分·········································· 36

5.4.3  總平面圖的繪制········································  36

第6章   技術(shù)經(jīng)濟(jì)與概算

6.1 產(chǎn)品成本概算及經(jīng)濟(jì)效益分析··································  37

結(jié)論與展望······················································  38

致謝·······················································  39

參考文獻(xiàn)···················································  40