一文了解纯化水系统
<div style="max-width:100%;overflow:hidden;"><p style="margin: 0px 0px 0em;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;clear: both;min-height: 1em;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;font-weight: 400;letter-spacing: 0.544px;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;word-spacing: 0px;-webkit-text-stroke-width: 0px;background-color: rgb(255, 255, 255);text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 17px;white-space: normal;widows: 2;visibility: visible;"><br></p><section data-support="96编辑器" data-style-id="39497" style="margin-bottom: unset;"><section data-align="title" style="margin:10px 0px;"><section style="display:flex;justify-content:center;align-items:center;"><section style="width:3px;"></section><section style="background-color: rgb(75, 138, 226);padding: 8px 10px;color: rgb(255, 255, 255);font-size: 18px;letter-spacing: 2px;margin: 0px 5px;box-sizing: border-box;"><p>典型的纯化水&注射用水制备系统</p></section><section style="width:3px;"></section></section></section></section><p><br></p><p><strong><span style="font-size: 14px;color: rgb(0, 82, 255);">1.纯化水制备系统</span></strong></p><p><span style="font-size: 14px;">典型的纯化水制备系统流程</span><span style="text-align: center;"></span></p><p><span style="font-size: 14px;"></span></p><p style="text-align: center;margin-bottom: 0em;"></p><p style="text-align: center;"><span style="font-size: 14px;">图1典型的纯化水制备系统流程</span></p><p style="text-align: center;"><span style="font-size: 14px;"><br></span></p><p><span style="font-size: 14px;">纯化水的制备应以饮用水作为原水，并采用合适的单元操作或组合的方法。常用的纯化水制备方法包括膜过滤、离子交换、电去离子（EDI）、蒸馏等，其中膜过滤法又可细分为微滤、超滤、纳滤、和反渗透（RO）等。</span></p><p><span style="font-size: 14px;"><br></span></p><p><span style="font-size: 14px;">纯化水制备工艺流程的选择需要考虑到以下因素：原水（一般为市政供水）的水质、业主对水质的要求、预防微生物污染措施和消毒措施、设备运行及操作人员的专业素质、不同季节原水水质变化的适应能力和可靠性、设备日常维护的方便性、设备的产水回收率及废液排放的处理、日常的运行维护成本、系统的监控能力。</span></p><p><span style="font-size: 14px;"><br></span></p><p><span style="font-size: 14px;">预处理单元一般包括多介质过滤器 、活性炭过滤器、软化器等多个单元。预处理单元主要目的是去除原水中的不溶性杂质、可溶性杂质、有机物与微生物，使其主要水质参数达到后续纯化系统的进水要求，从而有效减轻后续纯化系统的工作负荷，防止对于纯化系统造成污染或不可修复性损害。</span></p><p><span style="font-size: 14px;"><br></span></p><p><strong><span style="font-size: 14px;">多介质过滤器</span></strong><span style="font-size: 14px;">大多填充石英砂，石英砂应当根据粒径由大至小由下至上依次填充。石英砂层上面填充无烟煤或者绿砂。其主要作用是去处水中的大颗粒杂质、悬浮物。</span></p><p><span style="font-size: 14px;"><br></span></p><p><strong><span style="font-size: 14px;">活性炭过滤器</span></strong><span style="font-size: 14px;">主要是利用填充的活性炭的吸附和活性自由基除去水中的游离氯、色度、有机物以及部分重金属等有害物质。</span></p><p><span style="font-size: 14px;"><br></span></p><p><strong><span style="font-size: 14px;">软化器</span></strong><span style="font-size: 14px;">主要功能是通过钠型的软化树脂去除水中的硬度，如钙离子、镁离子，以防止钙、镁等离子在RO膜表面结垢。软化树脂需要通过再生才能恢复其交换能力，因此在是设计上通常采用双级串联软化系统以保证纯化水机连续运行。</span></p><p><span style="font-size: 14px;"><br></span></p><p><span style="font-size: 14px;">纯化系统一般有RO/RO/EDI，RO/RO，RO/EDI等多种工艺。纯化系统是经过关键的去离子、降低有机物、微生物与内毒素的过程，将预处理水“净化”为符合药典及药厂内控要求的纯化水。对余氯的去除能力是考察活性炭的主要指标。</span></p><p><span style="font-size: 14px;"><br></span></p><p><strong><span style="font-size: 14px;">反渗透装置</span></strong><span style="font-size: 14px;">（Reverse Osmosis，RO）采用反渗透这一最精密的膜法液体分离技术，它是一种只允许水分子通过而不允许溶质透过的半透膜。纯化水制备工艺中使用的膜材料主要为醋酸纤维素和芳香聚酰胺类。当预处理水进入反渗透系统后，可以除去大部分离子与细菌，同时有效去除微生物与TOC等，达到持续、稳定的低电导率、低细菌含量的高标准水质要求。</span></p><p><span style="font-size: 14px;"><br></span></p><p><span style="font-size: 14px;">典型的反渗透系统包括反渗透给水泵、阻垢剂加药装置、还原剂加药装置、5µm保安过滤装置、换热器、高压泵、反渗透装置、CO2脱气装置或NaOH加药装置以及反渗透清洗装置等。</span></p><p><span style="font-size: 14px;"><br></span></p><ul class="list-paddingleft-1" style="list-style-type: disc;"><li><p><span style="font-size: 14px;">给水泵：高压泵的作用是增加RO的进水压力使之高于水的渗透压。</span></p></li><li><p><span style="font-size: 14px;">阻垢剂、还原剂加药装置：纯化水制备系统中是否需要安装阻垢剂和还原剂加药装置，取决于原水水质、预处理的工艺选择与使用者要求等实际情况。</span></p></li><li><p><span style="font-size: 14px;">保安过滤器：防止大于5µm的颗粒物通过，保护RO膜免受伤害。</span></p></li><li><p><span style="font-size: 14px;">换热器：反渗透膜产水性能最高的工作温度是25℃，通常需要换热器对水温进行调节。</span></p></li></ul><p><br></p><p><span style="font-size: 14px;">CO2脱气装置：CO2气体几乎能完全透过RO膜，过多的CO2会导致产水电导率增高。</span></p><p><strong><span style="font-size: 14px;">电去离子装置</span></strong><span style="font-size: 14px;">（Electrodeionization，EDI）是一种电渗析工艺和离子交换工艺结合的系统。EDI工作原理是利用混合离子交换树脂吸附水中的阴、阳离子，同时这些被吸附的离子又在直流电场的作用下，分别透过阴、阳离子交换膜而被去除。</span></p><p><br></p><p><span style="color: rgb(0, 82, 255);"><strong><span style="color: rgb(0, 82, 255);font-size: 14px;">2.典型的注射用水制备流程</span></strong></span></p><p><span style="font-size: 14px;">《美国药典》规定：注射用水经蒸馏法，或比蒸馏法在移除化学物质和微生物水平方面相当或更优的纯化工艺制得。</span></p><p><span style="font-size: 14px;">《中国药典》规定：注射用水为纯化水经蒸馏所得的水。</span></p><p><span style="font-size: 14px;">《欧洲药典》规定：注射用水通过符合官方标准的饮用水制备，或者通过纯化水蒸馏制备，蒸馏设备接触水的材质是中性玻璃、石英或合适的金属，装有有效预防液滴夹带的设备。</span></p><p><br></p><p><span style="font-size: 14px;">因此在国内蒸馏法是我国药典认可的制取注射用水的唯一方法，源水必须采用符合《中国药典》标准的纯化水。</span></p><p><span style="font-size: 14px;"><br></span></p><p><span style="font-size: 14px;">未来随着我国制药用水系统产品的发展与技术成熟推动药典修订之后，超滤与纯化结合的方法制备注射用水等新型工艺也将得到应用和推广。</span></p><p><span style="font-size: 14px;">本文以制备注射用水最常见的多效蒸馏水机进行介绍。</span></p><p><span style="font-size: 14px;"><br></span></p><p><span style="font-size: 14px;">多效蒸馏水机的工作原理是让经充分预热的纯化水通过多级蒸发和冷凝，排除不凝性气体和杂质，从而获得高纯度的注射用水。</span></p><p><span style="font-size: 14px;"><br></span></p><p><span style="font-size: 14px;">多效蒸馏水机通常由多个蒸发换热器、分离装置、预热器、两个冷凝器、阀门、仪表和控制部分等组成。为防止系统发生交叉污染，多效蒸馏水机的第一效蒸发器、全部的预热器和冷凝器均需采用双端板管式设计。</span></p><p><span style="font-size: 14px;"><br></span></p><p><span style="font-size: 14px;">典型多效蒸馏水机的工作原理为原水在二效冷凝器被含纯蒸汽及蒸馏水的汽-液混合体加热，进入各效预热器被二次蒸汽及蒸馏水加热，然后在第一效柱蒸发器顶部经分配装置井去除不凝性气体，均匀地分布进入蒸发列管，在蒸发列管内形成均匀的液膜，同列管外壁流动的工业蒸汽进行热交换，迅速蒸发成为蒸汽，在压力差的作用下往柱体下部运动，未被蒸发的原水被输送到下一效，作为次效蒸发器的原水，以后各效与此类似，未被蒸发的进入下一效，直到最后一效仍未被蒸发的液体将作为废水排放。原水被蒸发为纯蒸汽，继续在蒸发器底部的汽-液分离装置进入纯蒸汽管路作为下一效的热源，蒸汽在下一效被吸收热量后凝结成注射用水，各效过程与此相似。注射用水和纯蒸汽混合物经过第二级冷却（纯化水为冷介质）和第一级冷却（冷却水为冷介质）后，成为设定温度的注射用水，经电导率仪在线检测合格的蒸馏水作为注射用水输出，不合格的蒸馏水将被自动排放。</span></p><p><o:p><span style="font-size: 14px;"> </span></o:p></p><p style="text-align: center;margin-bottom: 0em;"></p><p><o:p><span style="font-size: 14px;"></span></o:p></p><p style="text-align: center;"><span style="font-size: 14px;">图2多效蒸馏水机工作原理示意图</span></p><p><br></p><section data-support="96编辑器" data-style-id="39497" style="margin-bottom: unset;"><section data-align="title" style="margin:10px 0px;"><section style="display:flex;justify-content:center;align-items:center;"><section style="width:3px;"></section><section style="background-color: rgb(75, 138, 226);padding: 8px 10px;color: rgb(255, 255, 255);font-size: 18px;letter-spacing: 2px;margin: 0px 5px;box-sizing: border-box;"><p>典型的制药用水储存和分配系统</p></section><section style="width:3px;"></section></section></section></section><p><span style="font-size: 14px;"><br></span></p><p><span style="color: rgb(0, 82, 255);"><strong><span style="color: rgb(0, 82, 255);font-size: 14px;">1.储存和分配系统</span></strong></span></p><p><span style="font-size: 14px;">制药用水的储存与分配系统包括储存单元、分配单元和用水点管网单元。制药用水分配系统的设计形式多种多样，基本理念是在合理的成本下最大限度降低运行风险和微生物风险。</span></p><p><span style="font-size: 14px;"><br></span></p><p><strong><span style="font-size: 14px;">储存单元</span></strong><span style="font-size: 14px;">：储存单元用来储存符合药典要求的制药用水并满足系统的最大峰值用量要求。储存系统必须保持供水质量，以便保证产品终端使用的质量合格。</span></p><p><span style="font-size: 14px;">储存单元常见部件：</span></p><ul class="list-paddingleft-1" style="list-style-type: disc;"><li><p><span style="font-size: 14px;">储罐：储存制药用水；</span></p></li><li><p><span style="font-size: 14px;">压力表：安装于储罐上用于观察储罐内压力；</span></p></li><li><p><span style="font-size: 14px;">液位传感器：监测储罐中液位的高度（液位高度常与补水阀和输送泵联锁控制）；</span></p></li><li><p><span style="font-size: 14px;">温度传感器：监测储罐内液体温度；</span></p></li><li><p><span style="font-size: 14px;">呼吸器：用于保持储罐与外界压力平衡；</span></p></li><li><p><span style="font-size: 14px;">爆破片：罐体内部压力出现异常时的爆破保护装置。</span></p></li></ul><p><span style="font-size: 14px;"><br></span></p><p><strong><span style="font-size: 14px;">分配单元</span></strong><span style="font-size: 14px;">：大多数为循环管路式设计。分配系统的主要功能是将符合药典要求的制药用水输送到工艺用水点，并保证其压力、流量和温度符合工艺生产或清洗等的需求。</span></p><p><span style="font-size: 14px;">分配单元常见部件：</span></p><ul class="list-paddingleft-1" style="list-style-type: disc;"><li><p><span style="font-size: 14px;">输送管道：制药用水输送；</span></p></li><li><p><span style="font-size: 14px;">输送泵：常带变频控制；</span></p></li><li><p><span style="font-size: 14px;">压力传感器：监测循环管路中压力（常与输送泵联锁控制）；</span></p></li><li><p><span style="font-size: 14px;">温度传感器：监测循环管路制药用水的温度，常与换热器蒸汽或冷水阀联锁控制；</span></p></li><li><p><span style="font-size: 14px;">电导率仪：安装于回水位置，监测循环管路制药用水的电导率；</span></p></li><li><p><span style="font-size: 14px;">TOC仪：安装于回水位置，监测循环管路制药用水的TOC；</span></p></li><li><p><span style="font-size: 14px;">流量传感器：安装于回水位置，监测回水流量；</span></p></li><li><p><span style="font-size: 14px;">喷淋球：安装于储罐回水口，保证制药用水回流储罐时处于喷洒状态以润湿储罐。</span></p></li></ul><p><br></p><p><span style="color: rgb(0, 82, 255);"><strong><span style="color: rgb(0, 82, 255);font-size: 14px;">2.储存和分配单元消毒方式介绍</span></strong></span></p><p><span style="font-size: 14px;">对于储存和分配单元需要定期消毒以减少微生物滋生的可能。常见的消毒方法如下：</span></p><ul class="list-paddingleft-1" style="list-style-type: disc;"><li><p><span style="font-size: 14px;">化学品溶液消毒</span></p></li></ul><p><span style="font-size: 14px;">常用5%的双氧水或1%的过氧乙酸。市售的有多种不同混合液或其他化学品同样能达到消毒效果。化学消毒剂需要考虑到对管道的腐蚀以及消毒剂残留问题。</span></p><ul class="list-paddingleft-1" style="list-style-type: disc;"><li><p><span style="font-size: 14px;">臭氧消毒</span></p></li></ul><p><span style="font-size: 14px;">臭氧消毒分两种方式，连续型和间歇型。采用水电解法制备臭氧的连续型消毒中浓度很低的臭氧（0.05~0.1mg/L）就可以将微生物控制在很低的水平。采用水电解法制备臭氧的间歇型消毒可能需要0.1~0.2ppm的浓度，如果系统中滋生了微生物膜或制备臭氧的工艺为空气源/氧气源方法，则需要更高的臭氧浓度。消毒完成后水中的臭氧需要用紫外灯破除。</span></p><ul class="list-paddingleft-1" style="list-style-type: disc;"><li><p><span style="font-size: 14px;">热消毒</span></p></li></ul><p><span style="font-size: 14px;">将水处理系统加热来进行定期消毒是非常安全有效的。消毒周期取决于系统设计。</span></p><p><span style="font-size: 14px;">纯化水分配系统中的循环处理水加热到80±3℃, 并将此温度保持一段经过验证的时间。</span></p><p><span style="font-size: 14px;">注射用水可采用纯蒸汽灭菌与过热水灭菌两种工艺。因经济、安全等特征，采用过热水灭菌方式在逐渐增多，对此种方式要求系统是密闭压力系统，将系统中水加热至121℃仍不汽化而保持为液态水循环达到灭菌目的。</span></p><pre style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;font-size: 17px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;font-weight: 400;orphans: 2;text-align: justify;text-indent: 0px;text-transform: none;word-spacing: 0px;-webkit-text-stroke-width: 0px;text-decoration-style: initial;text-decoration-color: initial;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);line-height: 25.6px;widows: 1;visibility: visible;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word !important;line-height: 25.6px;white-space: normal;visibility: visible;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word !important;visibility: visible;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word !important;line-height: 25.6px;visibility: visible;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word !important;visibility: visible;"><section style="margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word 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