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Mliq纯水

发布时间: 2021-01-01 14:45:27

1. 百度里人们提问用的LZ、HIV、IQ、ML、带表的是什么意思呀

LZ就是楼主。顶头发言的人。
HIV就是艾滋。
IQ就是智商。
ML就是做,爱。

第一个是拼音缩写,后面的是英文缩写。

我自己打的,不是复制和粘贴,记得加分

2. 纯化水设备的3Q(IQ OQ PQ)验证具体是哪些

净得瑞为您解答:
纯化水设备3Q有三点:
1.DQ设计确认
设计确认(DQ)在《药品专生产验证指南》中明确解属释为“预确认,即设计确认,通常指对待订购设备技术指标适应性的审查及对供应厂商的选定。”同时,在《药品生产质量管理规范实施指南》中认为“预确认:是对设备的设计与选型的确认。
2.IQ安装确认
安装确认(IQ)主要是通过设备安装后,确认设备安装符合设计要求,文件及附件齐全,通过检验并用文件的形式证明设备的存在。也就是说,通过检查文件和其它项目,来确认设备和系统是按照设计安装的,并符合设备和系统设计要求和标准,并且已经正确地安装了。
3.OQ运行确认
运行确认(OQ)是通过空载运行实验,检查和测试设备运行、操作和控制性能通过记录并以文件形式证实制药机械(设备)符合生产工艺的要求。在安装确认后有设备的制造方和使用方共同根据验证方案进行运行确认,对设备运行性能的符合性、协调性进行确认。

3. 纯化水设备系统验证内容有哪些呢

纯化水设备系统验证文件即4Q验证,包含IQ安装确认、OQ运行确认、PQ性能确认、DQ设计确认,以下是详细内容:(详细的系统验证流程可进入【carryclean科瑞】网站查看)
1.IQ安装确认
安装确认(IQ)主要是通过设备安装后,确认设备安装符合设计要求,文件及附件齐全,通过检验并用文件的形式证明设备的存在。也就是说,通过检查文件和其它项目,来确认设备和系统是按照设计安装的,并符合设备和系统设计要求和标准,并且已经正确地安装了。
IQ安装确认包括
•包装确认
•设备清单
•安装过程确认
•材料确认(与产品直接接触的)
•仪器部分确认
•润滑剂确认(与产品接触的润滑剂必须是食 品级的)
•各种技术图纸及操作指南确认
•公用系统确认
2.DQ设计确认
设计确认(DQ)在《药品生产验证指南》中明确解释为“预确认,即设计确认,通常指对待订购设备技术指标适应性的审查及对供应厂商的选定。”同时,在《药品生产质量管理规范实施指南》中认为“预确认:是对设备的设计与选型的确认
DQ设计确认包括
对设备的性能、材质、结构、零件、计量仪表和供应商等的确认
PID图确认
GAD图确认
部件清单
电路图

3.OQ运行确认
运行确认(OQ)是通过空载运行实验,检查和测试设备运行、操作和控制性能通过记录并以文件形式证实制药机械(设备)符合生产工艺的要求。在安装确认后有设备的制造方和使用方共同根据验证方案进行运行确认,对设备运行性能的符合性、协调性进行确认。
OQ运行确认包括
测试仪器校准
设备/系统各部分功能测试
指示器,互锁装置和安全控制检测
报警器检测
断电和修复

4.PQ性能确认
性能确认(PQ)性能确认是对设备实际运行效果的确认,性能确认应在完成运行确认并已得到认可 后进行。是在制药套工艺技术指导下进行工业性负载生产,用模拟生产的方法,通过观察、记录、取样检测等手段,搜集及分析数据证明制药机械(设备)运行的可靠性和对生产的适应性。
PQ是模拟生产的过程,由使用者按照药品生产的工艺要求进行实际生产运行, PQ需要按每套设施设备及其相关工艺程序制定个别的确认方案。

carryclean科瑞提供完整的系统验证服务,提供专业的DQ、IQ、OQ、PQ系统文件。行业首创超纯水设备三维模拟制造安装,客户全程参与,设备细节效果提前展示,全方位保障客户需求。

4. GMP医药纯化水设备系统

GMP卫生级不锈钢洁净管道工程

提供卫生级不锈钢洁净管道工程的设计、安装、调试、验证一条龙服务,可为客户提供从公用管线、工艺管网和卫生管线系统,包括有/无缝卫生级不锈钢管焊接的纯水、注射用水、洁净物料、洁净气体管线的设计和施工,并根据需要提供相应的DQ/IQ/OQ/PQ等验证文件,所有设计及施工符合FDA/cGMP要求。


纯化水系统PW(PurifiedWater)

根据用户水质,由资深水处理工程师进行专业设计,采用世界上先进的RO膜和其他工艺,出水水质稳定,完全符合世界各国药典纯化水标准。全套系统以模块化设计为指导思想,根据装置产能、配置情况,将反渗透、预处理设备、后处理设备等各单元进行模块化组合,全自动操作系统,系统高效自动冲洗,采用进口仪表,能对水质准确、连续分析、显示。


制药纯化水设备

三、纯化水设备工艺流程

典型医药纯化水设备制水工艺流程:

原水→原水增压泵→多介质过滤器→软化器→活性炭过滤器→精密过滤器→一级高压泵→一级反渗透→二级高压泵→二级反渗透→纯化水箱→纯化水输送泵→用水点→紫外线杀菌器→巴氏消毒装置


四、水质标准

1、符合中国药典2015版纯化水标准

2、电导率(25℃)<2μS/cm

3、TOC(总有机碳)<50ppb

4、细菌总数<10cfu/ml

5、符合新版GMP认证要求

5. 关于纯净水的英文文章

定义
Purified water is water from any source that is physically processed to remove impurities. Distilled water and deionized water have been the most common forms of purified water, but water can also be purified by other processes including reverse osmosis, carbon filtration, microporous filtration, ultrafiltration, ultraviolet oxidation, or electrodialysis. In recent decades, a combination of the above processes have come into use to proce water of such high purity that its trace contaminants are measured in parts per billion (ppb) or parts per trillion (ppt). Purified water has many uses, largely in science and engineering laboratories and instries, and is proced in a range of purities.

几种纯净水的方法形式Methods of water purifing
Distilled water has virtually all of its impurities removed through distillation. Distillation involves boiling the water and then condensing the steam into a clean container, leaving nearly all of the solid contaminants behind. Distillation proces very pure water but also leaves behind a leftover white or yellowish mineral scale on the distillation apparatus, which requires that the apparatus be frequently cleaned.
For many applications, cheaper alternatives such as deionized water are used in place of distilled water.
Double-distilled water (abbreviated "ddH2O", "Bidest. water" or "DDW") is prepared by double distillation of water. Historically, it was the de facto standard for highly purified laboratory water for biochemistry and trace analysis until combination methods of purification became widespread.
Deionized water which is also known as demineralized water (DI water or de-ionized water; can also be spelled deionised water, see spelling differences) is water that has had its mineral ions removed, such as cations from sodium, calcium, iron, copper and anions such as chloride and bromide. Deionization is a physical process which uses specially-manufactured ion exchange resins which bind to and filter out the mineral salts from water. Because the majority of water impurities are dissolved salts, deionization proces a high purity water that is generally similar to distilled water, and this process is quick and without scale builp. However, deionization does not significantly remove uncharged organic molecules, viruses or bacteria, except by incidental trapping in the resin. Specially made strong base anion resins can remove Gram-negative bacteria. Deionization can be done continuously and inexpensively using electrodeionization.
It should be noted that deionization does not remove the hydroxide or hydronium ions from water; as water self-ionizes to equilibrium, this would lead to the removal of the water itself.
Other processes are also used to purify water, including reverse osmosis, carbon filtration, microporous filtration, ultrafiltration, ultraviolet oxidation, or electrodialysis. These are used in place of, or in addition to the processes listed above.

饮用纯净水Drinking purified water
Many beverage manufacturers use distilled water to ensure a drink's purity and taste. Bottled distilled water is sold as well, and can usually be found in supermarkets. Water purification, such as distillation, is especially important in regions where water resources or tap water is not suitable for ingesting without boiling or chemical treatment.
Water filtration devices are becoming increasingly common in households. Most of these devices do not distill water, though there continues to be an increase in consumer-oriented water distillers and reverse osmosis machines being sold and used. Municipal water supplies often add or have trace impurities at levels which are regulated to be safe for consumption. Much of these additional impurities, such as volatile organic compounds, fluoride, and an estimated 75,000+ other chemical compounds[citation needed] are not removed through conventional filtration; however, distillation and reverse osmosis eliminate nearly all of these impurities.
The drinking of purified water has been both advocated and discouraged for health reasons. Purified water lacks minerals and ions, such as calcium, which are normally found in potable (drinking) water, and which have important biological functions such as in nervous system homeostasis. Some percentage of our daily consumption of these minerals and ions come from our drinking water, but most of them come from the food we eat, making DI water perfectly fine to drink if one has food in his or her system. The lack of naturally-occurring minerals in distilled water has raised some concerns. The Journal of General Internal Medicine[3] published a study on the mineral contents of different waters available in the US. The study concluded, "drinking water sources available to North Americans may contain high levels of Calcium, Magnesium, and Sodium and may provide clinically important portions of the recommended dietary intake of these minerals," and further encouraged indivials to "check the mineral content of their drinking water, whether tap or bottled, and choose water most appropriate for their needs." Since distilled water is devoid of minerals, supplemental mineral intake through diet is needed to maintain proper health.
It is often observed that consumption of "hard" water, or water that has some minerals, is associated with beneficial cardiovascular effects. As noted in the American Journal of Epidemiology, consumption of hard drinking water is negatively correlated with atherosclerotic heart disease.[4] Since distilled water is free of minerals, it will not have these potential benefits.
It has been suggested that because distilled water lacks fluoride ions that are added by a minority of governments (e.g., municipalities in the United States) at water treatment plants using sodium hexafluorosilicate or hexafluorosilicic acid for their effect on the inhibition of cavity formation: the drinking of distilled water may increase the risk of tooth decay.[citation needed] However, many medical authorities argue that the effects of fluoridation on teeth are topical (brushed on) rather than systemic (swallowed). Also the benefit of fluoride supplementation, for any purpose, should be cautioned e to potential negative effects to IQ and motor functions.
The costs associated with water distillation have generally been prohibitive. However, distilling water with solar water distillers is becoming increasingly popular around the world; they can be relatively simple to design and build.

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