符合GMP认证的纯化水设备
水质符合2000版药典标准和GMP中的各项规定
设备全自动运行和有条件的全自动处理程序（如反冲洗、再生、酸洗、消毒程序）
单体和管道设备符合GMP的要求（如后端处理设备如杀菌器、膜滤、终端水箱、管路均采用316L材料， 预处理设备的管路采用UPVC管材）
纯化水水质标准：
电阻率：≥0.5MΩ.CM，电导率：≤2μS
氨≤0.3μg/ml
硝酸盐≤0.06μg/ml
重金属≤0.5μg/ml
典型医药用纯水制备工艺流程
原水－原水加压泵－多介质过滤器－活性炭过滤器－软水器－精密过滤器－第一级反渗透－PH调节－中间水箱－第二级反渗透－纯化水箱－纯水泵－紫外线杀菌器－ 微孔过滤器－用水点 推荐新工艺
原水－原水加压泵－多介质过滤器－活性炭过滤器－软水器－精密过滤器－一级反渗透 设备－中间水箱－中间水泵－离子交换器－纯化水箱－纯水泵－紫外线杀菌器－微孔过滤器－用水点传统工艺
原水－原水加压泵－多介质过滤器－活性炭过滤器－软水器－精密过滤器－一级反渗透机－中间水箱－中间水泵－EDI系统－纯化水箱－纯水泵－紫外线杀菌器－微孔过滤器－用水点 新工艺
典型的纯化水制备系统
反渗透法：反渗透法制备纯水技术是60年代发展起来的新技术。由于它操作工艺简单，除盐和除热源效率高，又比较经济。《美国药典》从19版开始收载此法，为制备注射用水的法定方法之一。
机制：反渗透是渗透的逆过程，是指借助一定的推力（如压力差、温度差等）迫使溶液中溶剂组分通过适当的半透膜从而阻留某一溶质组分的过程。
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High purity water
Water purification equipment in line with the GMP certification
Water quality in line with the provisions of the 2000 version Pharmacopoeia standards and in GMP
Automatic processing program of automatic equipment operation and conditions (such asbackwash, regeneration, pickling, sterilization procedures)
The monomer and pipeline equipment to meet the requirements of GMP (such as the back-end processing equipment such as sterilization, membrane filtration, water tank, pipeline terminals are made of 316L material, pipe processing equipment using UPVC pipe)
Purification of water quality standards:
Resistivity: more than 0.5M Omega.CM, conductivity: less than or equal to 2 mu S
Ammonia is less than or equal to 0.3 g/ml
Nitrate is less than or equal to 0.06 g/ml
Heavy metal is less than or equal to 0.5 g/ml
Use of pure water for the typical pharmaceutical preparation process
Water - raw water pump - more medium filter activated carbon filter water softener - precision filter - first stage reverse osmosis PH adjustment and intermediate water tank second stage reverse osmosis purified water tank - - pure water pump - ultraviolet sterilizer - microporous filter - waterpoints to recommend new technology
Water - raw water pump - more medium filter activated carbon filter water softener - precision filter -a reverse osmosis equipment of middle water tank - the middle water pump - ion exchanger -purification tank - pure water pump - ultraviolet sterilizer - microporous filter - water point of traditional craft
Water - raw wa, ter pump - more medium filter activated carbon filter water softener - precision filter -a stage reverse osmosis machine intermediate water tank - the middle water pump EDI system -purification tank - pure water pump - ultraviolet sterilizer microwell filter water new process
Purified water prepared by the typical system
Ro: reverse osmosis water technology is the preparation of a new technology developed in the 60.Because of its simple operation process, removing salt and in addition to heat efficiency is high,and the economic comparison. "USA Pharmacopoeia" began to collect the set from the 19 edition ofthis method, one of the legal methods for the preparation of water for injection.
Mechanism: reverse osmosis is a reverse process of osmosis, refers to the use of certain thrust(such as pressure difference, temperature difference and so on) forced solution solvent componentprocess through appropriate semipermeable membrane to detention of a solute components
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