无菌原料药车间设计说明书设计团队：太原工业学院跃起动力队队长：高士庚队员：牛倩倩 关鑫 焦文鑫 王康玉 李蕾指导老师：王曼 邵圣娟1摘要本次设计主要是美罗培南（三水化合物）原料药的车间设计。美罗培南是以缩合物、四氢呋喃、钯炭、甲醇、氢气等为原料，经加氢还原得美罗培南（三水化合物）粗品，再经精制得美罗培南（三水化合物）成品，总收率为86.50%。精品含量 99.0%。为实现工业化生产，根据任务书中的内容，以 250 天为基准，生产 25 吨的美罗培南（三水化合物）原料药，进行车间设计以及综合考虑共用设备问题。在设计中，首先对原料药生产的设计依据进行了说明，然后对产品进行了介绍。结合工艺流程，绘制了带控制点的工艺流程图；其次，以设备为单位进行了物料衡算，列出了各设备的进出物料平衡表。以此为基础，完成热量衡算，确定了加热和冷却介质的用量。同时，进行了设备选型计算，确定各设备的型号和生产能力。此外，又根据山西省太原市尖草坪地区的风向特点、安全、消防的需要，设计了矩形车间，并根据所选的设备绘制了工艺设备安装的平面布置图，并对主管线分布进行了初步设计。在设计中，也建立消防等安全防范制度，最后对生产情况进行了详细的劳动组织和人员安排。最后，结合工艺中产生的废弃物性质和排放量，制定了综合利用和“三废”的初步处理方法。关键词：美罗培南；车间布置；工艺设计无菌原料药车间设计说明书2AbstractThis design is mainly in accordance with meropenem (trihydrate) API workshop. Meropenem is a refined production which is from the crude material combined with condensation compound, tetrahydrofuran, Pd-C, methanol, hydrogen and so on by hydrogenation. The total yield is 86.50% and purity is 99.0%Based on the task content, to realize industrial production of meropenem (trihydrate) API (with 25 ton in 250 working days), the workshop was designed with the consideration of shared equipments.In the design, firstly, the design basis and the introduction of meropenem API were described, and the pipe and instruments designs were drawn out. Secondly, the material balance was carried out with a list of input and output material balance data on the basis of the instruments as units. Depending on the above material balance, energy balance was finished to determine heating and cooling medium dosages. At the same time, the calculation of selected instruments was to decide the each equipment production capacity and models. Additionally, the design conducted a rectangle of workshop layout according to the wind direction of Jiancaoping area of Taiyuan City, Shanxi province, safety and anti-fire characteristics, and the layout of installed instruments was drawn out according to the selected instruments, and it set up the management rules of anti-fire and safety, and so on. Finally, the preliminary processing methods of comprehensive applications and “three wastes” were made up in virtue of waste characteristics and output.Keywords: Meropenem; Workshop layout; Process design无菌原料药车间设计说明书3目录摘要 .1Abstract .2第 1 章 概述 .81.1 产品简介 .81.1.1 产品用途 .81.1.2 名称及结构 .81.1.3 理化性质 .81.1.4 药理及临床应用 .91.2 设计任务 .101.2.1 设计题目 .101.2.2 设计基础条件 .101.3 设计依据及原则 .11第 2 章 美罗培南的初步设计 .122.1 工艺流程 .122.1.1 工艺路线 .122.1.2 工艺过程 .122.1.3 工艺流程框图 .142.2 物料衡算 .152.2.1 物料衡算过程 .152.2.2 各工段和各岗位物料衡算 .172.2.3 物料流程框图 .272.3 能量衡算 .292.3.1 能量衡算依据及基准 .292.3.2 热量平衡方程式 .292.3.3 不同工段的热量衡算 .30第 3 章 工艺设备选型及计算 .