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In the whole process of ethambutol producing manufacturing shop GMP, we pay attention to the implement of GMP, because the equipment size dimension directly relates to plants layout and technological requirements.We had a relatively clear calculation and analysis about the material balance, the energy balance and the equipment selection. This design will be emphasized with the following points.
1. The main production process route: We mainly have the condensation reaction, which is the key to the material balance and energy balance, in which 2 molecules d-A generated the ethambutol, and the rest generated the ethambutol dihydrochloride, and after the rejection filter, drying to get products.
2. Workshop layout and GMP implement design: According to the requirements of GMP, process the order and a clear principle of shunt about people and material,to pide the workshop area in a reasonable manner, fully reflecting the advantages of “U” type workshop. After the pision, according to the ethambutol production process route and requirements, making the selection and classification of the workshop area cleanliness. As for the production safety, setting two river entrances, to make sure there has a independent personnel purification area for the refined drying package and the composition, so that there is no cross between the streams of people and material and no possibility of cross contamination.
3. Workshop air conditioning purification system design: The design is mainly based on the use of plant cleanliness, to design the air conditioning purification system. From the air return mode of the centralized air conditioning system to the platoon wind dc exhaust system and the anti-backflow system.
4. The air pressure design in the clean room: The air pressure control in clean rooms has an important effect on the whole technological process and guaranteeing that there is no pollution in the products, so we make design and control of pressure in each clean room according to the cleanliness, to further prevent the pollution.
5. The design of cleanliness in clean area: There are two areas of different cleanliness, in which the compounding area, the intermediate storage area and the delicate dry area are 300,000 degrees, and the outsource area is 100,000 degrees. To meet the different cleanliness requirements by controlling the air output in each area.
6. We also have relative designs about the land development. Because there are usages of shaking devises in the ethambutol production process route, for example, centrifugal machines and pumps, in the design of land development,these facilities need independent foundations in order to prevent the dangers.
Keywords ：d ,1-2-amino-butanol, EMB, Design，GMP
目录
1综述及说明 1
2合成工艺路线介绍 2
3物料衡算 3
3.1 缩合 3
3.1.1进料 4
3.1.2 出料 6
3.2 成盐 8
3.3.1 进料 9
3.3.2 出料 9
3.3 甩滤（成盐） 11
3.4.1 进料 11
3.4.2 出料 12
4热量衡算 14
4.1化学反应热 14
4.2其他反应热 18
5设备选型 20
6典型设备计算 23
6.1概述 23
6.2 塔型选择 24
6.3操作条件的确定 24
6.4有关的工艺计算 25
6.4.1最小回流比及操作回流比的确定 25
6.4.2塔顶产品产量、釜残液量及加热蒸汽量的计算 26
6.4.3全凝器冷凝介质的消耗量 27
6.4.4热能利用 27
6.4.5理论塔板层数的确定 28