《药品生产质量管理规范》对设备的要求：

u 设备的设计、选型、安装应符合药品生产要求，易于清洗、消毒或灭菌，便于生产操作和维修、保养，并能防止差错或减少污染。

u 与药品直接接触的设备表面应光洁、平整、无死角、易清洗或消毒、耐腐蚀，不与药品发生化学变化或吸附药品。

u 设备所用的润滑剂、冷却剂等不得对药品或容器造成污染。管道的设计和安装应避免死角、盲管。

u 用于生产和检验的仪器、仪表、量具、衡器等，其适用范围和精密度应符合生产和检验要求，有明显的合格标志，并定期校验。

u 生产设备应有明显的状态标志，并定期维修、保养和验证。设备安装、维修、保养的操作不得不影响产品的质量。

u 对有特殊要求的仪器、仪表，应安放在专门的仪器室内，并有防止静电、震动、潮湿或其它外界因素影响的设施。

 

Application of Centrifuge in Pharmaceutical-Industry

Requirements for equipment:

u The design, selection and installation of equipment shall conform to the requirements of drug production and be easy to clean, disinfect or sterilize, Easy to operate&repair. Maintain, prevent errors or reduce pollution.

u The surface of equipment in direct contact with drugs should be smooth, free of dead angles, easy to clean or disinfect, corrosion resistant, No chemical changes with drugs or adsorption of drugs.

u Lubricant, coolant, etc. used for equipment shall not cause contamination of medicines or containers. The pipe shall be designed and installed in such a way as to avoid dead-angle and blind pipes.

u Instruments, gauges,  weighing devices, ete., used for production and inspection, whose scope of application and precision shall conforrn to the requirements of production and inspection, and shall have clearly qualified marks.

u Production equipment should have clear Status sign, and regular repair, maintenance and verification. Installation, repair and maintenance of equipment must affect the quality of the product.

u For instruments and instruments with special requirements, they should be placed in a special instrument room with facilities to prevent static electricity, vibration, moisture or other external factors.

 

 

离心工艺试验与验证

可滤性和沉降速度是选型的主要依据。通过对固液相混合物的理化特性进行分析、试验、确定分离工艺，进行必要的技术经济分析（产品品质、收率、能耗、产能、运行安全），选择合适的分离设备。在满足分离工艺技术要求的前提下，进行必要的参数优化，达到更高的产量、收率，更小的能耗和消耗。

在进行过滤试验时，选择合适的过滤介质、卸料方式、洗涤方式等；当固液两相密度差很小时，尽可能不要采用沉降方法进行固液两相分离，或者通过适当的工艺方法增大密度差，或通过离心力的作用来增加其分离动力。

过滤与分离是一门实验技术，对于特定的物料和工况，通过积累的经验和进行必要的试验获得过滤与分离数据，选择适用的分离设备和分离工艺，达到预期目的。

 

Centrifugal Process Test and Verification

Filtration and settlement speed are the main basis for selection. the separation process is determined according to the physical and chemical properties of solid-Iiquid mixture is analyze. and the necessary technical and economic analysis( product quality, yield，energy consumption，production capacity, operation safety) is carried out. and suitable separation equipment is selected. the necessary parameters were optimized to achieve higher yield，Iower energy consumption and consumption under the premise of satisfying the technical requirements of separation process.

we should choose the proper filtration medium，discharge method and washing method etc in the filtration test. we should not use settling method to separate solid and liquid phase when the density difference between solid and liquid phase is very small. Either by appropriate process to increase the density difference, or through the centrifugal force to increase its separation power.

Filtration and separation is an experimental technique. For specific materials and working conditions. the data of filtration and separation are obtained through accumulated experience and necessary tests. and the suitable separation equipment and process are selected to achieve the desired purpose.