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         根据中华人民共和国药典对制药行业用水要求的说明,医药用水分主要分为三类:纯化水注射用水、灭菌注射用水;

纯化水:为符合最新版《生活饮用水卫生标准》的原水经蒸馏法、离子交换法、反渗透法或其他适宜的方法制得的制药用水,不含任何附加剂。纯化水可作为配制普通药物制剂的溶剂或试验用水,不得用于注射剂的配制。
注射用水为纯化水经蒸馏处理所得的水。
灭菌注射用水为注射用水依照注射剂生产工艺制备所得的水。
制药行业用水的首要目标是能够提供满足药典要求的优质纯化水。
 
纯化水的解决方案
漂软针对医药行业用水的要求及特点,提供符合GMP及中国药典要求的用于医用器具的精洗、医药制剂、医用大输液、生物制剂、基因工程、肾透析等方向的高品质纯化水处理设备,去除水中的杂质,并进一步采用膜分离和离子交换的多效组合的方式彻底去除病原细菌及热源等。
 
主要工艺流程:
原水、原水泵、多介质过滤器、活性碳过滤器、软化器、一级精密过滤器、一级反渗透、二级反渗透、混合离子交换器、紫外杀菌器、纯水箱、纯水泵、回流紫外杀菌器、用水点。 
 
 
  
 
纯化水的水质要求
经漂软医药用水处理系统处理后的纯水达到中华人民共和国药典中纯化水水质标准:
电导率: ≤5.1μS/cm@25℃;
总有机碳: ≤0.5mg/L;
   ≤0.3μg/ml
硝酸盐: ≤0.06μg/ml;
重金属: ≤0.1μg/ml。
 
 
漂软医药行业用水处理系统的优势
 
Purosoft的制药用水制备系统以模块化为设计理念,以预处理、RO反渗透、混合离子交换床、UV消毒和储存外输等功能单元为基础,在设计、制造、调试过程中将世界领先技术、膜及离子交换工艺和严格的质量控制贯彻到整个系统,采用先进的全自动控制软件、无人值守运行;最终产水装置根据其用水标准的不同,经由各功能模块优化组合而成,从而保证了整个系统的高性能与高质量,使产品水完全达到或超过纯化水的水质标准,为客户提供不间断的后续保障服务。
 
漂软提供符合GMP认证的医药水处理系统:
1】水质符合2010版药典标准和GMP中的各项规定;
2】 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);
3】单体设备和管道等符合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)。

 

 

 

 

Chinese Pharmaceuticals provides standards for the following grades of water:
Purified water: water for preparation of medical products other than those that require the use of water which is sterile. Purified water is prepared by distillation, by ion exchange, by reverse osmosis or by any other suitable method.
 
Water for injections: water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms.
 
Sterile water for injection: further purified injection water according to the injection water purification process.
 
Purified Water Solutions
Purosoft water treatment system provides water which complies with the standard in GMP certification and Chinese Pharmaceuticals which can be used as a cleaning agent for rinsing vessels, Medical preparation, injection, medical used transfusion, genetic engineering, kidney dialysis. It completely removes impurities and pathogenic bacteria by further separation with the combined technology of membranes and IER.
 
The Process
Tap water, tap water pump, Multi-media filter, Activated carbon filter, Softener, 
 First pass RO, Second pass RO, mixed bed IER filter, UV, pure water tank, pure water pump, counter flow UV, point of use
 
  
 
Purify water standard
Water purified from Purosoft system meets the purify water standard in Chinese Pharmaceuticals
Conductivity: ≤5.1μS/cm@25℃;
TOC: ≤0.5mg/L;
Ammonia   ≤0.3μg/ml
Nitrate: ≤0.06μg/ml;
Heavy metals: ≤0.1μg/ml。
 
 
Purosoft advantages on waterTreatment System for Pharmaceutical Use
 
Purosoft purification system is designed based on module functional units such as pre-treatment, RO membrane, mixed bed IER, UV sterile, storage and offloading, and adopted world leading technology and strict quality control into the system design, production and commission process. The system works perfectly with PLC control software to allow unattended (not watched) operation. Different grades of water quality can be achieved by various combinations of different functional units, which gives the system a high quality and excellent performance that guarantees the product water quality reaches or exceeds the pure water standard. Purosoft provides after service to ensure constant high quality of purified water.
 
Purosoft supplies water purification system which complies with GMP certification
1】Water quality complies with requirements in Chinese Pharmaceuticals 2010 version and GMP certification.
2】 Fully automatic operation and conditional automatic operation (such as back wash, regeneration, acid wash, disinfection program etc.)
3】The Equipments and pipes are GMP certified (equipments like sterilizer, membrane filters, storage tank and pipes all made from 316Lss and use UPVC pipes in pre-treatment equipments)

 

 

 
 
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