Mliq純水
1. 百度里人們提問用的LZ、HIV、IQ、ML、帶表的是什麼意思呀
LZ就是樓主。頂頭發言的人。
HIV就是艾滋。
IQ就是智商。
ML就是做,愛。
第一個是拼音縮寫,後面的是英文縮寫。
我自己打的,不是復制和粘貼,記得加分
2. 純化水設備的3Q(IQ OQ PQ)驗證具體是哪些
凈得瑞為您解答:
純化水設備3Q有三點:
1.DQ設計確認
設計確認(DQ)在《葯品專生產驗證指南》中明確解屬釋為「預確認,即設計確認,通常指對待訂購設備技術指標適應性的審查及對供應廠商的選定。」同時,在《葯品生產質量管理規范實施指南》中認為「預確認:是對設備的設計與選型的確認。
2.IQ安裝確認
安裝確認(IQ)主要是通過設備安裝後,確認設備安裝符合設計要求,文件及附件齊全,通過檢驗並用文件的形式證明設備的存在。也就是說,通過檢查文件和其它項目,來確認設備和系統是按照設計安裝的,並符合設備和系統設計要求和標准,並且已經正確地安裝了。
3.OQ運行確認
運行確認(OQ)是通過空載運行實驗,檢查和測試設備運行、操作和控制性能通過記錄並以文件形式證實制葯機械(設備)符合生產工藝的要求。在安裝確認後有設備的製造方和使用方共同根據驗證方案進行運行確認,對設備運行性能的符合性、協調性進行確認。
3. 純化水設備系統驗證內容有哪些呢
純化水設備系統驗證文件即4Q驗證,包含IQ安裝確認、OQ運行確認、PQ性能確認、DQ設計確認,以下是詳細內容:(詳細的系統驗證流程可進入【carryclean科瑞】網站查看)
1.IQ安裝確認
安裝確認(IQ)主要是通過設備安裝後,確認設備安裝符合設計要求,文件及附件齊全,通過檢驗並用文件的形式證明設備的存在。也就是說,通過檢查文件和其它項目,來確認設備和系統是按照設計安裝的,並符合設備和系統設計要求和標准,並且已經正確地安裝了。
IQ安裝確認包括
•包裝確認
•設備清單
•安裝過程確認
•材料確認(與產品直接接觸的)
•儀器部分確認
•潤滑劑確認(與產品接觸的潤滑劑必須是食 品級的)
•各種技術圖紙及操作指南確認
•公用系統確認
2.DQ設計確認
設計確認(DQ)在《葯品生產驗證指南》中明確解釋為「預確認,即設計確認,通常指對待訂購設備技術指標適應性的審查及對供應廠商的選定。」同時,在《葯品生產質量管理規范實施指南》中認為「預確認:是對設備的設計與選型的確認
DQ設計確認包括
對設備的性能、材質、結構、零件、計量儀表和供應商等的確認
PID圖確認
GAD圖確認
部件清單
電路圖
3.OQ運行確認
運行確認(OQ)是通過空載運行實驗,檢查和測試設備運行、操作和控制性能通過記錄並以文件形式證實制葯機械(設備)符合生產工藝的要求。在安裝確認後有設備的製造方和使用方共同根據驗證方案進行運行確認,對設備運行性能的符合性、協調性進行確認。
OQ運行確認包括
測試儀器校準
設備/系統各部分功能測試
指示器,互鎖裝置和安全控制檢測
報警器檢測
斷電和修復
4.PQ性能確認
性能確認(PQ)性能確認是對設備實際運行效果的確認,性能確認應在完成運行確認並已得到認可 後進行。是在制葯套工藝技術指導下進行工業性負載生產,用模擬生產的方法,通過觀察、記錄、取樣檢測等手段,搜集及分析數據證明制葯機械(設備)運行的可靠性和對生產的適應性。
PQ是模擬生產的過程,由使用者按照葯品生產的工藝要求進行實際生產運行, PQ需要按每套設施設備及其相關工藝程序制定個別的確認方案。
carryclean科瑞提供完整的系統驗證服務,提供專業的DQ、IQ、OQ、PQ系統文件。行業首創超純水設備三維模擬製造安裝,客戶全程參與,設備細節效果提前展示,全方位保障客戶需求。
4. GMP醫葯純化水設備系統
GMP衛生級不銹鋼潔凈管道工程
提供衛生級不銹鋼潔凈管道工程的設計、安裝、調試、驗證一條龍服務,可為客戶提供從公用管線、工藝管網和衛生管線系統,包括有/無縫衛生級不銹鋼管焊接的純水、注射用水、潔凈物料、潔凈氣體管線的設計和施工,並根據需要提供相應的DQ/IQ/OQ/PQ等驗證文件,所有設計及施工符合FDA/cGMP要求。
純化水系統PW(PurifiedWater)
根據用戶水質,由資深水處理工程師進行專業設計,採用世界上先進的RO膜和其他工藝,出水水質穩定,完全符合世界各國葯典純化水標准。全套系統以模塊化設計為指導思想,根據裝置產能、配置情況,將反滲透、預處理設備、後處理設備等各單元進行模塊化組合,全自動操作系統,系統高效自動沖洗,採用進口儀表,能對水質准確、連續分析、顯示。
制葯純化水設備
三、純化水設備工藝流程
典型醫葯純化水設備制水工藝流程:
原水→原水增壓泵→多介質過濾器→軟化器→活性炭過濾器→精密過濾器→一級高壓泵→一級反滲透→二級高壓泵→二級反滲透→純化水箱→純化水輸送泵→用水點→紫外線殺菌器→巴氏消毒裝置
四、水質標准
1、符合中國葯典2015版純化水標准
2、電導率(25℃)<2μS/cm
3、TOC(總有機碳)<50ppb
4、細菌總數<10cfu/ml
5、符合新版GMP認證要求
5. 關於純凈水的英文文章
定義
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.
幾種純凈水的方法形式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.
飲用純凈水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.