《藥品生產(chǎn)質(zhì)量管理規(guī)范》對(duì)設(shè)備的要求：
u 設(shè)備的設(shè)計(jì)、選型、安裝應(yīng)符合藥品生產(chǎn)要求，易于清洗、消毒或滅菌，便于生產(chǎn)操作和維修、保養(yǎng)，并能防止差錯(cuò)或減少污染。
u 與藥品直接接觸的設(shè)備表面應(yīng)光潔、平整、無(wú)死角、易清洗或消毒、耐腐蝕，不與藥品發(fā)生化學(xué)變化或吸附藥品。
u 設(shè)備所用的潤(rùn)滑劑、冷卻劑等不得對(duì)藥品或容器造成污染。管道的設(shè)計(jì)和安裝應(yīng)避免死角、盲管。
u 用于生產(chǎn)和檢驗(yàn)的儀器、儀表、量具、衡器等，其適用范圍和精密度應(yīng)符合生產(chǎn)和檢驗(yàn)要求，有明顯的合格標(biāo)志，并定期校驗(yàn)。
u 生產(chǎn)設(shè)備應(yīng)有明顯的狀態(tài)標(biāo)志，并定期維修、保養(yǎng)和驗(yàn)證。設(shè)備安裝、維修、保養(yǎng)的操作不得不影響產(chǎn)品的質(zhì)量。
u 對(duì)有特殊要求的儀器、儀表，應(yīng)安放在專門的儀器室內(nèi)，并有防止靜電、震動(dòng)、潮濕或其它外界因素影響的設(shè)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(yàn)與驗(yàn)證
可濾性和沉降速度是選型的主要依據(jù)。通過(guò)對(duì)固液相混合物的理化特性進(jìn)行分析、試驗(yàn)、確定分離工藝，進(jìn)行必要的技術(shù)經(jīng)濟(jì)分析（產(chǎn)品品質(zhì)、收率、能耗、產(chǎn)能、運(yùn)行安全），選擇合適的分離設(shè)備。在滿足分離工藝技術(shù)要求的前提下，進(jìn)行必要的參數(shù)優(yōu)化，達(dá)到更高的產(chǎn)量、收率，更小的能耗和消耗。
在進(jìn)行過(guò)濾試驗(yàn)時(shí)，選擇合適的過(guò)濾介質(zhì)、卸料方式、洗滌方式等；當(dāng)固液兩相密度差很小時(shí)，盡可能不要采用沉降方法進(jìn)行固液兩相分離，或者通過(guò)適當(dāng)?shù)墓に嚪椒ㄔ龃竺芏炔睿蛲ㄟ^(guò)離心力的作用來(lái)增加其分離動(dòng)力。
過(guò)濾與分離是一門實(shí)驗(yàn)技術(shù)，對(duì)于特定的物料和工況，通過(guò)積累的經(jīng)驗(yàn)和進(jìn)行必要的試驗(yàn)獲得過(guò)濾與分離數(shù)據(jù)，選擇適用的分離設(shè)備和分離工藝，達(dá)到預(yù)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.