符合GMP認證的純化水設備
水質符合2000版藥典標準和GMP中的各項規定
設備全自動運行和有條件的全自動處理程序（如反沖洗、再生、酸洗、消毒程序）
單體和管道設備符合GMP的要求（如后端處理設備如殺菌器、膜濾、終端水箱、管路均采用316L材料， 預處理設備的管路采用UPVC管材）
純化水水質標準：
電阻率：≥0.5MΩ.CM，電導率：≤2μS
氨≤0.3μg/ml
硝酸鹽≤0.06μg/ml
重金屬≤0.5μg/ml
典型醫藥用純水制備工藝流程
原水－原水加壓泵－多介質過濾器－活性炭過濾器－軟水器－精密過濾器－第一級反滲透－PH調節－中間水箱－第二級反滲透－純化水箱－純水泵－紫外線殺菌器－ 微孔過濾器－用水點 推薦新工藝
原水－原水加壓泵－多介質過濾器－活性炭過濾器－軟水器－精密過濾器－一級反滲透 設備－中間水箱－中間水泵－離子交換器－純化水箱－純水泵－紫外線殺菌器－微孔過濾器－用水點傳統工藝
原水－原水加壓泵－多介質過濾器－活性炭過濾器－軟水器－精密過濾器－一級反滲透機－中間水箱－中間水泵－EDI系統－純化水箱－純水泵－紫外線殺菌器－微孔過濾器－用水點 新工藝
典型的純化水制備系統
反滲透法：反滲透法制備純水技術是60年代發展起來的新技術。由于它操作工藝簡單，除鹽和除熱源效率高，又比較經濟。《美國藥典》從19版開始收載此法，為制備注射用水的法定方法之一。
機制：反滲透是滲透的逆過程，是指借助一定的推力（如壓力差、溫度差等）迫使溶液中溶劑組分通過適當的半透膜從而阻留某一溶質組分的過程。
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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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