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《藥品生產質量管理規范》對設備的要求:

u 設備的設計、選型、安裝應符合藥品生產要求,易于清洗、消毒或滅菌,便于生產操作和維修、保養,并能防止差錯或減少污染。

u 與藥品直接接觸的設備表面應光潔、平整、無死角、易清洗或消毒、耐腐蝕,不與藥品發生化學變化或吸附藥品。

u 設備所用的潤滑劑、冷卻劑等不得對藥品或容器造成污染。管道的設計和安裝應避免死角、盲管。

u 用于生產和檢驗的儀器、儀表、量具、衡器等,其適用范圍和精密度應符合生產和檢驗要求,有明顯的合格標志,并定期校驗。

u 生產設備應有明顯的狀態標志,并定期維修、保養和驗證。設備安裝、維修、保養的操作不得不影響產品的質量。

u 對有特殊要求的儀器、儀表,應安放在專門的儀器室內,并有防止靜電、震動、潮濕或其它外界因素影響的設施。

 

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.

 

 

離心工藝試驗與驗證

可濾性和沉降速度是選型的主要依據。通過對固液相混合物的理化特性進行分析、試驗、確定分離工藝,進行必要的技術經濟分析(產品品質、收率、能耗、產能、運行安全),選擇合適的分離設備。在滿足分離工藝技術要求的前提下,進行必要的參數優化,達到更高的產量、收率,更小的能耗和消耗。

在進行過濾試驗時,選擇合適的過濾介質、卸料方式、洗滌方式等;當固液兩相密度差很小時,盡可能不要采用沉降方法進行固液兩相分離,或者通過適當的工藝方法增大密度差,或通過離心力的作用來增加其分離動力。

過濾與分離是一門實驗技術,對于特定的物料和工況,通過積累的經驗和進行必要的試驗獲得過濾與分離數據,選擇適用的分離設備和分離工藝,達到預期目的。

 

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, yieldenergy consumptionproduction capacity, operation safety) is carried out. and suitable separation equipment is selected. the necessary parameters were optimized to achieve higher yieldIower energy consumption and consumption under the premise of satisfying the technical requirements of separation process.

we should choose the proper filtration mediumdischarge 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.

 

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