制药用水系统介绍.pptx

Pharmaceutical Water Systems制药用水系统第1页 ? Alfa LavalSlide 2Water storage and distribution system水贮存和分派系统The most common and well known system in the pharmaceutical industry. 是最常规Still, many confusions on how to select the most suitable, hygienic and cost effective solution然而，在怎么选择最合适、卫生和成本、效能方面最困惑The key is to understand the basic principle关键是要懂得基本原理第2页 ? Alfa LavalSlide 3Feed waterReverseosmosisElectro-deionisationTankDistillation systemTankWater purification distribution loop纯化和分派Purification processDistribution loop第3页 ? Alfa LavalSlide 4Definitions定义ISPE differentiate between three types of water: ISPE辨别三种水：USP Purified Water (PW) 美国药典纯化水（PW）USP Water for Injection (WFI)注射水Non- compendial water (RO, DI, etc.)饮用水第4页 ? Alfa LavalSlide 5Sterile bulk API or BPCWFI PW, in practice WFI和PW使用Injectable dosage formWFINon-injectable dosage formPWBulk API or BPCSuitable non-compendialAPI = Active Pharmaceutical Ingredient活性药用成份（原料药）BPC = Bulk Pharmaceutical Chemical（医药中间体）Minimum water typeEquipment cleaning and rinsingISPE recommendation ISPE推荐第5页 ? Alfa LavalSlide 6USP Specifications定义: PW vs. WFI*In-line measurement, from equivalent values from USP table CFU=Colony Forming UnitsAll Pharmaceutical water must also meet the EPA standard for microbiological quality of potable waterPW (Purified Water)WFI (Water for Injection)Water conductivity and pH 1,3 μS/cm at 25°C* pH 5-7 1,3 μS/cm at 25°C* pH 5-7Total Organic Carbon (TOC) 0.5 ppm 0.5 ppmAerobic Microbial Contamination 100 CFU/ ml 10 CFU/100 ml (0.1 CFU/ml)Endotoxin contentNot Specified 0.25 EU/mlProduction MethodsObtained by suitable processObtained by suitable process and purified by distillation.第6页 ? Alfa LavalSlide 7Bacteria basics for water systems水系统中微生物基本知识Aerobic Bacteria 好氧菌Gram Negative 葛兰氏阴性菌Gram Positive 葛兰氏阳性菌Endotoxin 内毒素Biofilm 生物膜第7页 ? Alfa LavalSlide 8Bacteria basics for water systems水系统中微生物基本知识Most common bacteria in pharmaceutical water systems are Gram negative bacteria. Gram negative ba