重组牛碱性成纤维细胞生长因子原液生产车间工艺设计.docVIP

PAGE 29 重组牛碱性成纤维细胞生长因子原液生产车间工艺设计 摘 要 重组牛碱性成纤维细胞生长因子（Recombinant bovine basic fibroblast growth factor，简称rb-bFGF）是一种用于急慢性溃疡、创伤等症状的药品。能刺激来源于中胚层和神经外胚层细胞的生长，如成纤维细胞、血管内皮细胞、角膜细胞、上皮细胞、神经细胞、肌细胞、骨细胞等，有广泛的生物活性。日常生活中常应用于美容行业和各种溃疡、创伤、烧伤等治疗，能显著地缩短伤口愈合周期。具有良好的市场前景。本设计主要包括：根据发酵、纯化工艺对生产工艺选择、生产所需设备的选型、成本估算、物料衡算、生产车间的设计和CAD图纸的绘制等。对车间的设计符合GMP标准加上适当的创新，实现人与物料分离，保证了车间的生产效率，有效地避免污染和交叉污染，便与车间的清洁操作和维护。稳定生产质量的同时尽可能减少成本，确保车间的经济效益。 关键词：重组牛碱性成纤维细胞生长因子；设备选型；物料衡算；CAD图纸绘制；车间设计； Process design of production plant of recombinant bovine basic fibroblast growth factor stock solution Abstract Recombinant bovine basic fibroblast growth factor (RB bFGF) is a kind of drug for acute and chronic ulcer, trauma and other symptoms. It can stimulate the growth of mesoderm and neuroectoderm cells, such as fibroblasts, vascular endothelial cells, corneal cells, epithelial cells, nerve cells, muscle cells, bone cells, etc. it has a wide range of biological activities. In the daily life, it is often used in the beauty industry and treatment of various ulcers, wounds, burns, etc., which can significantly shorten the wound healing cycle. It has a good market prospect. The design mainly includes: according to fermentation and purification process, production process selection, selection of equipment required for production, cost estimation, material balance, design of production workshop and drawing of CAD drawings, etc. The design of the workshop conforms to GMP standard and appropriate innovation, realizes the separation of people and materials, ensures the production efficiency of the workshop, effectively avoids pollution and cross pollution, and facilitates the clean operation and maintenance of the workshop. Stabilize the production quality while reducing the cost as far as possible, ensure the economic benefit of the workshop. Keywords: Recombinant bovine basic fibroblast growth factor; Equipment selection; Material balance; CAD drawing; Workshop design 目 录 TOC \o 1-5 \h \z \u 1前言 1 1.1概述 1 1.1.1