GMP Water System(cGMP培训系列1)PPT.pptx

GMP Water System GMP水系统GMP Training Module 12DisclaimerThe following slides are copied from WHO presentation on water system in Shanghai on Feb 28 – March 4, 2005. 声明?根据世界卫生组织的有关培训材料改写而成Part IWater Pre-treatment水的预处理Water Introduction and treatment水的引入和处理Objectives目标Introduction to Water for Pharmaceutical UseReview WHO GMP guidance Sources and types of water for pharmaceutical useStorage of bulk, untreated raw waterPre-treatment of waterPrinciples (2)Potential for microbial growthSystems must be properly validatedWater for parenteral use could be contaminated with pyrogens or endotoxinsSpecifications and periodic testing is required?原则2微生物生长可能系统必须被论证注射用水可能被污染定期测试Types of water used in pharmaceutical processes Purified water Water for Injections – PFW WFI Softened Water Water for Final Rinse Pure, or clean Steam Water for cooling Autoclaves?原则2微生物生长可能系统必须被论证注射用水可能被污染定期测试Why purify raw water?水为什么要净化？Although reasonably pure, it is always variableSeasonal variations may occur in waterSome regions have very poor quality waterMust remove impurities to prevent product contamination.Control microbes to avoid contaminating productsContaminants of water (1)水的可能污染源There is no pure water in nature, as it can contain up to 90 possible unacceptable contaminantsContaminant groups:Inorganic compoundsOrganic compoundsSolids GasesMicro-organisms无机，有机，固体，液体，微生物Contaminants of water (2)水的污染源2Treatment depends on water’s chemistry and contaminants, influenced by: Rainfall Erosion Pollution Dissolution Evaporation Sedimentation Decomposition雨水，腐蚀，污染，水溶物，蒸发物，沉淀物及分解物Contaminants of water (3)Problem minerals 水的污染物 3 矿物质Calcium and magnesium Iron and manganeseSilicatesCarbon dioxideHydrogen sulfidePhosphatesContaminants of water (4)Further problem minerals 水的污染物4重金属CopperAluminiumHeavy metalsArsenic, lead, cadmiumNitratesContaminants of water (5)Micro-organisms – Biofilm水的污染物5 生物膜水草，原生动物，细菌AlgaeProtozoaCryptosporidiumGiardiaBacteriaPseudomonasGram negative, non-fermenting bacteriaEsch