年产150万瓶氨甲环酸注射液的生产车间设计.doc

年产150万瓶氨甲环酸注射液的生产车间设计 摘要：该设计是针对中小型制药企业的车间工艺设计，即年产150万瓶氨甲环酸注射液的生产工艺设计。首先简要说明了该注射液的临床用途及规格等介绍，接着主要进行该药的配制方法、物料衡算、工艺选择、反应釜设备的计算及选型、车间布局等。工艺过程条件需经济合理，且必须符合GMP《药品生产质量管理规范》的要求。该设计还系统介绍了三废处理、经济衡算、生产能力及估算市场前景。并绘制了车间布置图、工艺流程图及主辅设备图。 关键词： 氨甲环酸注射液；物料衡算；工艺设计；车间布置 The production workshop design of annual 1.5 million bottles of tranexamic acid injection Abstract：The design was aimed at middle-small scale enterprise of pharmaceutical, the annual output of 1.5 million bottles of Tranexamic Acid injection of production process design. Firstly, it illustrated the clinical uses and specifications of the injection in briefly. And then it introduced the main methods of preparation of the injection. At lost the material balance and process selection were calculated in the design, and the major equipments for the reactor jacket in mixturing were selected by equipments’ parameters and calculated data, the shop layout and so on. The process conditions are required for economic rationality, and must also comply with the GMP requirements. The production design has also introduced how to deal with the waste water, waste gas and materials in brief, production capacity and estimated the market prospects. It enclosed drawing of workshop layout, diagram of process flow and a main equipment drawing and a supplementary equipment drawing. Key words: Tranexamic Acid injection; material balance; technological design; workshop layout 目录 引言 1 1、指导思想和设计原则 4 1.1 指导思想 4 1.2 设计原则 4 1.3 厂址选择 4 1.4 工艺流程设计 4 1.5 设备选型及制剂车间的布置 4 1.6 空调净化系统 5 2、工艺流程设计 6 2.1 概述 6 2.2 制剂工程设计的基本要求 6 2.3工艺方案设计 6 2.3.1设计参数 6 2.3.2生产过程概述 6 2.3.3注射剂的容器与处理 7 2.3.4.注射液的过滤 9 2.3.5注射液的灌封 10 2.3.6注射液的灭菌 10 2.3.7灯检 10 2.3.8印字包装 11 2.4 生产工艺流程 11 3、 物料衡算 13 3.1 生产能力 13 3.2物料衡算 13 3.2.1质量守恒定律 13 3.2.2相应条件 13 3.2.3物料计算 13 3.2.4物性参数 14 3.2.5物料衡算列表 14 3.3物料流程 14