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单效浓缩器工作原理
单效浓缩器是一种常见的蒸馏设备，它主要用于将溶液中的溶质浓缩至所需浓度。
其工作原理如下：
1. 溶液进入单效浓缩器：首先，待浓缩的溶液通过进料管道进入单效浓缩器。
溶液通常含有溶质和溶剂，溶液的浓度根据需求可以有所不同。
2. 加热器加热溶液：当溶液进入单效浓缩器后，溶液将被加热器加热。
加热的目的是通过提供热能使溶剂蒸发，而溶质则留在溶液中。
加热器可以使用各种热源，例如蒸汽或电加热。
3. 溶剂蒸发：在加热的作用下，溶剂开始蒸发。
通常情况下，热能会导致溶剂从液态状态转变为气态状态。
而溶质则保持在溶液中，并且其浓度会随着溶剂的蒸发而增加。
4. 蒸汽冷凝：蒸发的溶剂蒸汽会进入冷凝器，在那里通过降温而冷凝成液体。
通常情况下，所用冷却介质（如水）将从冷凝器底部进入，并在与蒸汽接触的过程中接收热量。
这将导致冷却介质升温并最终排出。
5. 浓缩液收集：经过蒸汽冷凝后，生成的液体称为浓缩液。
浓缩液中的溶质浓度较高，因为溶剂已经蒸发部分。
浓缩液将从单效浓缩器的底部收集，并可以进一步进行处理或使用。
通过以上步骤，单效浓缩器可以将溶液中的溶质浓缩至所需浓
度。
这种浓缩方法适用于许多工业和实验室应用，如制药、化工和食品加工等领域。
题目: 单效低温连续蒸发浓缩机组用户需求标准（URS）Title：User Requirements Specification for Single-effectlow-temperature continuous evaporatingconcentrator文件号:File Code：替代文件: 无Replaced File：总页数页Total pages：生效日期年月日Effective Date：目录一、目的3二、范围3三、参考文献3四、设备描述3五、技术要求41.单效低温连续蒸发浓缩系统技术规格说明4六、安全要求6七、GMP要求61.清洁要求62.材质焊接要求73.所需文件清单7一、目的对采购的单效低温连续蒸发浓缩机组的设计、材质、制造检查和测试制定标准，使其满足产品生产工艺及GMP法规要求。
二、范围本用户说明适用于XX制药有限公司新产品开发及生产用单效低温连续蒸发浓缩机组的采购制造及使用。
三、参考文献1)C E安全及噪音标准2)E N 61010-1 电气设计3)E N-ISO 12100-1, -2: 2003 / EN-ISO 14121-1, -2: 2007 机械设计4)E N 61326-15)c GMP规范：------中国《药品生产质量管理规范》2015年修订版------欧盟GMP------ CGAMP 5（良好自动化生产实践指南）------FDA - 21 CFR Part 11: 电子记录和电子签名四、设备描述单效低温连续蒸发浓缩机组是一套低温循环浓缩系统，用于对温度比较敏感五、技术要求七、GMP要求。
乙醇回收浓缩器操作指导书
（ISO9001-2015）
一、参数
1.1设计：蒸汽压力≤0.09Mpa蒸发能力300—600Kg/h
1.2实际：蒸汽压力≤0.09Mpa蒸发能力400—500Kg/h
二、检查准备
2.1检查各阀门电器、仪表是否处于良好状态。
2.2检查清场合格证、设备完好证。
2.3填写并挂上状态卡。
三、设备操作
3.1打开低压视镜灯，打开真空系统，开启阀门（五、6、7），关闭阀门（8、1
三、9、10、1四、1五、三、16、17、四、2）使机内真空度达到0.04Mpa时，开启阀门（三、6），将料液抽至蒸发室第二视镜中间部位关闭（三、16）然后破坏真空，关闭（16）打开（8）。
3.2打开阀门（一、11），进蒸汽加热料液，同时开启冷却水阀门（12），开始浓缩。
3.3当冷却器贮罐冷却液达到视镜一半时，关闭阀门（7）打开阀门（9），开启JN-2泵排到JC-1贮罐后复原。
3.4收膏结束时，关闭阀门（一、12），开阀门（4）进水，按该设备清洁规程清洁至合格后关闭全部阀门，关闭低压视镜灯。
四、维护保养
4.1经常检查视镜孔、灯孔、维修孔各连接管处的密封，必要时更换密封圈，经常检查各阀门是否是否漏气、漏水。
4.2经常检查压力表、真空表、温度表的灵敏度、精密度，每周至少一次。
4.3电机定期加注润滑油。
4.4大修期为一年，大修时对保温层应检查，损坏和失效者应更换或替补。
五、注意事项
5.1出膏时用真空混匀，再测比重，合格后放料，料液必须用300目筛绢过滤。
5.2如操作中机件损坏或出现断水故障，应立即停止使用，先关闭蒸汽阀门，然后关冷却水阀。
JM系列降膜浓缩器产品说明书河南天浩机械设备有限公司目录一、机组简介 (2)二、机组组成及特点 (2)三、工作原理 (4)四、型号规格及技术参数 (4)五、安装及使用 (6)六、清洗 (8)七、常见故障及排除 (8)八、注意事项 (9)一、机组简介机组用于中药、西药、食品、饮料、化工、轻工等液体物料的浓缩，能满足热敏性中药、西药及热敏性类其它物料浓缩的要求，能回收溶媒。
机组加热室与蒸发室分开，不仅易于清洗更换，同时物料在加热室与蒸发室间不停的快速循环，加热面附近的溶液浓度梯度差较小，有利于减轻结垢。
机组采用微真空浓缩，这样可降低溶液的沸点。
真空浓缩具有下列优点：1.因为溶液在真空下的沸点比在常压下低，当加热蒸汽的压力一定时，采用真空浓缩可降低溶液的沸点，从而提高传热有效温度差，增加推动力，强化了蒸发操作。
当热流量一定时，传热面积可减小。
2.对加热源的要求可降低，提供了可利用低压蒸汽或废热蒸汽作热源的可能性。
3.由于操作压力低于常压，溶液沸点下降可减少或防止热敏性物料的分解，可以浓缩不耐高温的溶液，宜用于处理热敏性溶液。
另外物料自上而下气液分离器速度在3-5秒中完成。
4.由于降低了溶液沸点，可减少热损失。
5.蒸发量（清水）与一次蒸汽（饱和水蒸汽）耗量比为1∶1～1.1。
二、机组组成及特点机组组成（详见总装图）机组由加热室、蒸发室、除沫器、冷凝器、冷却器、受液罐及连接管件等构成，整套设备由不锈钢SUS304或SUS316L制造。
加热室：加热室为双层结构，隔热保温，内部为列管式，物料通过布膜器均匀分不到列管当中、弯头连通蒸发室，打开加热室上、下盖即可清洗列管；加热室蒸汽管道上应装蒸汽压力表、安全阀，以确保生产安全。
蒸发室：蒸发室为双层结构，隔热保温，正面设有视镜，顶端设有视孔灯，配有真空表、温度表，方便操作者观察、掌握蒸发室内真空度、液料温度及液料的蒸发情况。
除沫器：除沫器内装不锈钢波纹填料，减少物料的损失，有利于汽液分离。
用户需求标准（URS）单效浓缩器XXXXXX有限公司2014年05月文件审批：目录1、简述2、目的3、范围4、缩写列表5、设备标准6、项目描述7、用户及系统要求1 简述为实施清洁生产、提高生产效率，达到节能减排的目的，XXXXXX有限公司计划新采购一台DJN-2000L/h型单效浓缩器。
2 目的本用户需求文件旨在从项目和系统的角度阐述用户的需求，概括了用户对浓缩设备单效浓缩器的质量要求，描述了用户对该设备的工作过程及功能的期望，主要包括相关法规符合度和用户的具体需求。
这份文件是构建起项目和系统的文件体系的基础，同时也是系统设计和验证的可接受标准的依据。
设备生产商应在规定的时间内完成并达到本用户需求的设计目标和可接受的质量标准。
在本URS中用户仅提出基本的技术要求和设备的基本要求，并未涵盖和限制卖方设备具有更高的设计与制造标准和更加完善的功能、更完善的配置和性能、更优异的部件和更高水平的控制系统。
供应商应在满足本URS的前提下提供卖方能够达到的更高标准和功能的高质量设备及其相关服务。
卖方的设备应满足中国有关设计、制造、安全、环保等规程、规范和强制性标准要求。
本文件中未列出的具体要求，以最新相关版本的法律或行业标准为依据。
如遇与卖方所执行的标准发生矛盾时，应按较高标准执行（强制性标准除外）。
3 范围该文件为荣昌制药（淄博）有限公司新购单效浓缩器的用户需求文件，该文件是对单效浓缩器的设计、生产、安装、检查和测试、文件、交付的说明和最低要求。
该URS在移交给供应商之后，意味着所有指定的要求被涵盖在供应商的供应范围之内。
4 缩写列表5 设备标准：设备必须符合以下标准、规范5.1法规5.1.1《药品生产质量管理规范》（2010年修订）及附录GMP（2010）5.1.2《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》5.2 国家、行业标准5.2.1 ISO 146445.2.2《中国药典》2010年版行业标准5.2.3 GBZ 1-2010 工业企业设计卫生标准5.2.4 GB20021-2004中华人民共和国制药机械行业标准5.2.5 药品生产自动化管理规范（GAMP）5.2.6 工业自动化仪表工程施工验收规范GBJ—93—865.2.7 电气装置安装工程低压电器施工质量验收规范GB50245-965.2.8 所有电气设备的电线和电缆必须依据ICE标准5.2.9 GB/T4735-1997 钢制常压容器制造标准5.2.10 GB151-1999 管壳式换热器国家标准5.3 安全：达到以下标准5.3.1 GB-52261-2002 机械安全机械电气设备第一部分：通用技术条件5.3.2 GB-8196-87 机械设计防护罩安全要求6 项目描述根据荣昌制药（淄博）有限公司中药提取浓缩生产工艺要求，新购进1台蒸发量为2000L/h的浓缩设备，用于醇沉后药液的浓缩。
Service provided by:Oxygen Concentrators A User Guide02Oxygen Concentrators. A User Guide.Contents3 The Basics4 Airsep Newlife Elite and Intensity5 Everflo6 Sysmed M507 VisionAire V3 and V58 Millennium9 After Use10 Fixed Installation11 Dos and Don’ts14 Troubleshooting15 Power Failure/Concentrator Breakdown16 Electricity Refund17 Home Oxygen Portal03Oxygen Concentrators. A User Guide.Important: Please ensure you read all accompanying literature supplied by your BOC Homecare Technician (HT) prior to usingyour home oxygen equipment. In particular, please pay attentionto the section on not smoking or allowing others to smoke nearyour equipment.The BasicsThe atmosphere is made up of 21% Oxygen, 78% Nitrogen and 1% trace gases. Oxygen therapy works by providing the patient with enriched oxygen of a far greater percentage. Oxygen is colourless, odourless and heavier than air.Oxygen concentrators draw in air and separate the oxygen from the other gases by absorption, leaving almost pure oxygen being delivered by tubing that connects to a canula or mask, enabling you to breathe more easily. Tubing length can be varied but the maximum length that can be provided is 15 metres. The tubing can become a trip hazard so we suggest considering something called a Fixed Installation. This means keeping the concentrator in a fixed position and having outlet points in several rooms, shortening the tubing length and reducing the risk of trips and falls. Your homecare technician can explain this in more detail and carry out a survey to see if it is suitable for you.The concentrator plugs into the mains electricity supply in your home and uses about 350 Watts per hour (which is relatively low).You will be supplied with a model of concentrator, dependent on your condition and individual needs.If you have any questions please ask your homecare technician.04Oxygen Concentrators. A User Guide.Airsep Newlife Elite and IntensityUsing your concentrator1. Connect the tubing and cannula to the oxygen outlet2. Insert the power cord plug into the electrical outlet3. Set the power switch to ON4. Turn the flowmeter adjustment knob to the flow line prescribed by your physician5. The concentrator is now ready for use6.When not using the machine always turn the power switch to OFFImportant parts of your concentratorFlow meter Flow meter hour meter Oxygen outletCircuit breaker reset buttonON/OFF05Oxygen Concentrators. A User Guide.EverfloUsing your concentrator1. Connect your nasal cannula to the oxygen outlet port2. Press the power switch to the ON position. Initially, all the LEDs will illuminate and the audible alarm will beep for a few seconds. After that time, only the green LED should remain lit. You can begin breathing from the device immediately even though it typically takes 10 minutes to reach oxygen purity specifications3. Adjust the flow to the prescribed setting by turning the knob on top of the flow meter until the ball is centred on the line marking the specific flow rate4. Put the cannula on as directed by your homecare technician5. When not using oxygen, always press the power switch to the OFF position Note: Everflo and V3 machines do not have filters that require cleaning.Important parts of your concentrator06Oxygen Concentrators. A User Guide.Sysmed M50Using your concentrator1. Connect the tubing and cannula to the oxygen outlet2. Insert the power cord plug into the electrical outlet3. Set the power switch to ON4. Turn the flowmeter adjustment knob to the flow line prescribed by your physician5. The concentrator is now ready for use6.When not using the machine always turn the power switch to OFFImportant parts of your concentrator07Oxygen Concentrators. A User Guide.VisionAire V3 and V5Using your concentrator1. Connect the tubing and cannula to the oxygen outlet2. Insert the power cord plug into the electrical outlet3. Set the power switch to ON4. Turn the flowmeter adjustment knob to the flow line prescribed by your physician5. The concentrator is now ready for use6.When not using the machine always turn the power switch to OFFNote: Everflo and V3 machines do not have filters that require cleaning.Important parts of your concentratorON/OFF switch Flow meter knob Flow meter knob ON/OFF switch08Oxygen Concentrators. A User Guide.MillenniumImportant parts of your concentratorFlow meter knobUsing your concentrator1. Connect the tubing and cannula to the oxygen outlet2. Insert the power cord plug into the electrical outlet3. Set the power switch to ON4. Turn the flowmeter adjustment knob to the flow line prescribed by your physician5. The concentrator is now ready for use6. When not using the machine always turn the power switch to OFF09Oxygen Concentrators. A User Guide. After UseTurn off the concentrator if you are not using it. The concentrator will only produce oxygen if it is plugged in and switched on. It will continue to do this until it is switched off.1. Press the ON/OFF switch on the front panelto the off position2. If you do not intend to use yourconcentrator for a number of hours, switch off at the mains socket.Looking after your concentratorRead the Safety information section carefully before carrying out the following simple maintenance tasks.1. Clean the cabinet occasionally with adamp cloth and wipe dry. Avoid gettingwater into the internals of the unit.Do not use any form of cleaner ordetergent when cleaning the concentrator 2. Wash the filter from the unit once a week.Your homecare technician will show youwhere the filter is located as this depends on the concentrator installed.• Remove the filter and replace with the spare filter• Hand wash in warm water• Rinse thoroughly and remove excess water with a clean absorbent towel • Allow filter to dry naturallyNote:Everflo and V3 machines do not have filters that require cleaning Oxygen suppliesThe oxygen concentrator can provide you with oxygen continuously for up to 24 hours per day every day of the year to meet your prescription.Our technician will visit every six months to carry out regular maintenance checks on the oxygen concentrator. The technician will go through how to use your equipment with you again and check that the concentrator is set at the prescribed flow rate.During the visit the technician will also check the tubing is in good condition and that the back-up cylinder (used for emergency use only such as power cuts) is full and operates correctly. The technician will also supply you with sufficient new cannulae or masks for use until your next scheduled visit, and any other consumable items which need replacing, for instance a spare filter for the concentrator.If further spares are required please contact our Patient Service Centre on 0800 136 603.If you have any questions or concerns, please raise these with your homecare technician or call the helpline.10Oxygen Concentrators. A User Guide. Fixed InstallationWhen your homecare technician first installs your oxygen equipment, you will be offered a fixed installation. This involves connecting clear plastic tubing from your concentratorto convenient points around your home.The advantage is you will be able to access oxygen in different rooms without havingto move the concentrator or have cylinders placed around your home or have long lengths of tubing dragging around the floor.A fixed installation will reduce the risk of trips and falls. We may need to supply you with portable cylinders, to get you from one room to another or back to the switch. Long lines will not be supplied on a piped install as this in itself will create a trip hazard.• Your homecare technician will complete a survey and risk assessment to ensure a piped installation is possible, then talk to youabout the best location for the concentrator.Please note we will be unable to install units in the kitchen, as this is a fire risk.• A wall tap will be placed in a suitable location to direct oxygen to the roomswhere you need it. Please ensure that you are going to turn the switch to the desired room which you would like to occupy• Tubing will be attached to skirting boards and door frames• For safety, fire breaks will be fitted in the tubing• A length of loose tubing will be left so you can move around each room• A hole 0.4 inch (10 mm) wide may need to be drilled through walls to access roomswhere you want the oxygen outlet• Due to health and safety reasons your homecare technician will NOT be ableto install fixed oxygen outlet in yourbathroom or kitchenFree line installationYour BOC homecare technician will advise you of the safest place for your concentrator to be located in your home.The technician will then attach a length of tubing with fire breaks to the concentrator that will allow you to walk around your home whilst using the oxygen.If you decide after having a free line installation that this is not right for you,we are happy to re-visit and install a piped oxygen system.CautionAs the tubing is free to move as you walk,we advise patients who are frail or at an increased risk of tripping to make sure they are happy to have the tubing move freely around them.1Outlet, 2Outlet, 3Concentrator Typical piped installationShould you require your free standing cylinders secured within your home we are able to offer that service. This is highly recommended if there are children around or visiting the home.These cylinders can be secured to your wall if required using a specialist fixing device. This will prevent the cylinders from falling or being pulled over in your home.General• On installation the homecare technician will set the concentrator to the prescribed flowrate setting. This is not to be adjusted.Never use a different flowrate unlessadvised to do so by your healthcareprofessional. Adjustments to flowrate areto be done by the homecare technician • Follow the advice we have given you about where to safely position your concentrator when it is in use• Keep your concentrator upright• Do not alter the original installation in any way without first contacting us• Position the concentrator at least 12 inches(30 cm) away from walls or otherobstructions to ensure the air intake is not obstructed• Position the concentrator at least 10 feet (three metres) away from naked flames such as open fires, gas fires and cookers and atleast five feet (1.5 metres) away from other heat sources or electrical appliances. • Always report any incidents, near misses or general safety concerns with regard to your oxygen supply.Dos and Don’tsIMPORTANT: Smoking guidance• Smoking around oxygen is extremelydangerous and may cause clothing,hair and skin to catch fire and burnmuch more vigorously than in air.• Never smoke or allow someoneelse to smoke whilst using youroxygen equipment.• Make sure you ventilate your clothingin the open air for at least 20 minutesbefore smoking or going nearanopen flame or source of ignition.• You should follow these same safetyprinciples with electronic cigarettes12Oxygen Concentrators. A User Guide.Back-up cylinder• You will be supplied with a high capacity back-up cylinder for use in an EMERGENCY ONLY (such as a power cut). To ensure you have sufficient oxygen in an emergencysituation, please do not use this cylinderfor any other use.Power lead• Always use the electrical socket identified as suitable during installation.• Allow enough slack on the power cord to prevent accidental unplugging.• Do not use extension cables, unless instructed to do so.• Do not move or pull the concentrator by the power lead as this may damage theinternal connections.Power• Never leave your oxygen concentrator running when it is not in use.• Never open or remove the concentrator cover at any time.• Only authorised personnel should carry out any repairs on your oxygen concentrator. Cleaning• Switch off and un-plug your concentrator from the mains supply when removing orreplacing the filter.• Regularly clean the air inlet filter of your concentrator as instructed in the Lookingafter your concentrator section of this guide.• After rinsing allow your filter to dry naturally. Please ensure that it is completely dry before replacing in machine• Do not apply heat to the filter.If you have been supplied a Respironics Everflo machine there are no filters for you to clean. All filters are internal and will be replaced during your routine service every six months. There is a grill at the air inlet which needs to be cleaned with a vacuum cleaner weekly – your homecare technician will show you how to do this.13Oxygen Concentrators. A User Guide.Face masks and cannulaeNasal cannulaA nasal cannula is a narrow, flexible plastic tube used to deliver oxygen through the nostrils. It connects to an oxygen source on one end and has a loop at the other end with dual pronged extended openings at the top of the loop. The prongs are slightly curvedto fit readily into the front portion of the nostrils. The tubing of the loop is fitted over the ears and is brought together under the chin by a sliding connector that holds the cannula in place.Face masksAn oxygen face mask is a plastic device that is shaped to fit over your nose and mouth.It is used to deliver oxygen as you breathe through either the nose or the mouth. An oxygen mask has holes either side which allows air to enter the mask and dilute the oxygen, as well as allowing exhaled carbon dioxide to leave the mask. It has narrow oxygen tubing fixed to the nozzle on the mask, the other end is then connected to the oxygen supply. An adjustable elastic band is connected to each side of the mask and slides over the head and above the ears to hold the mask firmly in place.HygieneUse a soft damp cloth to regularly clean face masks and nasal cannulas in accordance with the manufacturer’s instructions. Do not use cleaning agents.Suggested replacement frequencyThe cannula condition can deteriorate with age and it is recommended that the cannula is changed every month.Cannulas can become blocked with nasal fluids. Where this is a problem more frequent replacement may be required.14Oxygen Concentrators. A User Guide. Troubleshooting.15Oxygen Concentrators. A User Guide. Power Failure/Concentrator BreakdownWhat to do if your oxygen concentrator breaks down or you have a power failure.Switch to your back-up cylinder and call the Patient Service Centre on0800 136 603 to explain what the problem is. They will ask you a series of questions to determine what the problem might be. It is crucial that you give them as much information as you can. They will then give you advice on how to fix the problem or if this is not possible, they will arrange for one of our homecare technician’s to visit you. Our free phone line 0800 136 603 is open 24 hours a day every day of the year to respond to emergencies.For more information on power cuts, please contact on of the following:East of EnglandUK Power Network tel ***********East MidlandsWestern Power tel ***********Northern IrelandNorthern Ireland Electricity tel ***********If you feel unwell then it is important that you contact your doctor so that he/she can provide guidance.Back-up cylindersThese cylinders are provided for use in case of power failure or breakdown of theconcentrator.16Oxygen Concentrators. A User Guide.What is an electricity refund?As part of our service we will refund thecost of electricity used by the oxygen concentrator on a quarterly basis. After you have been using the oxygen concentratorfor approximately three months, a BOC patient service advisor will ring you to advise that a service is due on the equipment. It is important that you are available for this visit as the homecare technician will take the first reading of the concentrator hours meter. The meter reading will be entered into the BOC computer system.This will issue a refund paid by bank transfer Unless on a prepaid meter, BOCwill reimburse the electricity used by your concentrator at a standard regional rate defined by the NHS. You may benefit from lower electricity rates in your area, advice can be obtained from uSwitch on ***********. The service visitIt is very important your concentrator is first serviced after three months and then every six months after so that we can ensure it is in full working order. During these visits we can also check that you have enough cannulae/ masks.The ongoing processFuture concentrator service visits will be planned at six monthly intervals when a meter reading will be taken by our technician and a refund will be issued. In between these visits we will arrange to send you an estimated refund. Therefore three months after the concentrator service visit you will receive a further refund which is based on an estimate calculated by our computer system. How do we calculate theestimated refund?The computer is able to estimate the hours the concentrator has been used based on the readings taken at installation and also at the first service. If your oxygen usage has changedElectricity Refund17Oxygen Concentrators. A User Guide.Other features include:• Replenish your liquid unit • Arranging holiday oxygen • Re-ordering cannulas/masks• Add/update your bank details for electricity refunds • Electricity reimbursement queries •General queriesHome Oxygen PortalBOC now offers an online ordering system for your home oxygen cylinder prescription needs. This will enable you to place an order via our user-friendly portal, save you time and give you peace of mind. Registration is quick and easy and you can access the portal from your computer, smartphone, tablet or any internet enabled device.If you are visually impaired and require a large print copy, please contact us on0800 136 603Our normal working hours are Monday to Friday 8am until 6pm. We are open 24 hours for emergencies only.H L C /406720/C S T /0123BOC Healthcare is the trading name of BOC Limited registered office, Forge, 43 Church Street West, Woking, Surrey GU21 6HT, England. Company number 337663 – English Register. Authorised and regulated by the Financial Conduct Authority, register number 715528. BOC is a company name used by Linde plc and its affiliates. The BOC logo and the BOC word are trademarks or registered trademarks of Linde plc or its affiliates. Copyright © 2010–2023. BOC Ltd.BOC HealthcarePatient Service Centre, Priestley Road, Worsley, Manchester M28 2UT, United Kingdom Tel 0800 136603,**************************,。
单效真空浓缩器用户需求标准编制：审核：审批：目录1 总则 (3)3 缩写和定义 (4)4 设备系统描述 (5)5 技术要求 (5)7 参考条件 (12)8 相关系统 (12)1 总则1.1 目的本URS所列技术要求适用于提取车间“浓缩设备”的采购，包含单效真空浓缩器及其配套设备。
新引进的设备在设计、制造技术及性能上达到国内先进水平，符合中国2010年修订版GMP要求。
1.2 范围要求1.2.1 本URS描述了该设备的基本需求，包括：工作性能需求、关键技术参数要求、安全要求、符合中国GMP要求和安装及其他要求。
同时，这份用户要求文件也是开展后续相关验证工作的基础，包括：FAT草案和报告、DQ草案和报告、SAT草案和报告、IQ草案和报告、OQ草案和报告、PQ草案和报告。
1.2.2 在本URS中用户仅提出基本的技术要求和设备的基本要求，并未涵盖和限制卖方设备具有更高的设计与制造标准和更加完善的功能、更完善的配置和性能、更优异的部件和更高水平的控制系统。
卖方应在满足本URS的前提下提供卖方能够达到的更高标准和功能的高质量设备及其相关服务。
卖方的设备应满足中国有关设计、制造、安全、环保等规程、规范和强制性标准要求。
如遇与卖方所执行的标准发生矛盾时，应按较高标准执行（强制性标准除外）。
1.3 供货范围1.3.1包含以下设备：2000Kg/h的单效真空浓缩器1台1.3.2提供上述设备的独立报价。
2 适用的法规和指南制造过程使用的法规和指南以现行版为准，以下为在本用户需求标准URS中所参考的文献标准（仅供参考）：（1）EN292–1&2 Safety of Machinery –Basic Concepts, General Principles for Design. EN 292–1&2 机械安全-基本概念，设计的一般理论（2）EN 60204-1 Safety of Machinery - Electrical Equipment of Machinery. EN 60204-1 机械安全-机械电气设备（3）ASME Code. 美国机械工程师协会标准（4）GAMP4–Good Automated Manufacturing Practice Guide for Validation of Automated Systems in Pharmaceutical Manufacture生产自动化管理规范第4版（5）GEP–Good Engineering Practice. 良好工程管理规范（6）21CFR Part 11 Electronic Records; Electronic Signatures, 21CFR Part 11 电子记录；电子签名（7）中国药品生产质量管理规范（2010年修订版）（8）中国药典（2020版）（9）自动化仪表工程施工及验收规范（GB50093-2002）（10）钢制压力容器（GB150-2011）（11）钢制压力容器焊接规范（JB/T4709-2007）（12）钢制焊接常压容器（NB/T 47003.1—2009）（13）钢制焊接常压容器技术条件(JB2880-1981)（14）流体输送用不锈钢无缝钢管（GB/T14976-2002）（15）固定式压力容器安全技术监查规程（TSG R0004-2009)3 缩写和定义4 设备系统描述4.1基本描述本提取设备主要用于中药材乙醇回流液、渗漉液、醇沉上清液等的浓缩，收膏密度为1.10-1.30左右，回收药液中的乙醇。
单效浓缩器工作原理
单效浓缩器是一种常用的用于液体混合物浓缩的设备，它的工作原理如下：
1. 混合物进料：混合物首先从进料管道进入浓缩器的进料设备，如喷嘴或旋流器。
在进料设备中，混合物会在高速旋转或喷射的作用下形成薄层，并尽可能均匀地分布在传热表面上。
2. 传热：蒸汽或加热介质通过浓缩器的传热管道流动，与混合物接触并传递热量。
在这个过程中，混合物中的溶剂会逐渐蒸发，而溶质则在液体中浓缩。
3. 蒸汽回收：蒸汽在传热过程中与溶剂发生蒸发，成为含有溶剂的蒸汽。
蒸汽会从浓缩器的顶部或侧面排出，并进入蒸汽回收系统。
4. 浓缩物收集：浓缩后的液体通过液体排出装置，如放置在浓缩器底部的收集槽或离心机。
这样，溶质浓缩物和较少蒸发的溶剂就可以分离出来。
值得注意的是，单效浓缩器的效率较低，因为它只进行一次蒸发传热。
为了进一步提高浓缩效率，可以采用多效浓缩器，它是由多个浓缩器级联而成，利用多次蒸发传热来提高浓缩效果。
目录一、产品介绍 (3)二、产品特点 (3)三、重要技术参数 (3)四、结构及性能 (4)五、工作原理 (4)六、操作规程 (4)七、设备清洗 (5)八、注意事项 (6)九、设备的维护与保养 (6)十、合格证 (6)十一、随机附件 (7)一、产品介绍：刮板式浓缩罐是我公司最新研制开发用于中药提取液浓缩制备大比重浸膏的专用设备，浸膏最终浓度比重可达到约1.4（80℃测量），根据压力可以分为常压浓缩、真空、加压浓缩。
二、产品特点：1、采用刮壁式旋转刮板，使浓缩罐的传热面积及时更新，保证物料不会长时间的粘附在传热面上，使设备保持较高的传热系数、蒸发强度高。
2、旋转刮板使浓缩罐内的物料不停的搅拌翻动，物料受热均匀，避免了物料局部长时间受热而焦糊、碳化，保证了药品质量。
3、刮板式真空浓缩罐结构合理，有较大的蒸发分离空间，减少了汽液夹带现象，成品收率高，且低温下完成蒸发全过程，浸膏的色泽好，质量好。
4、出料时旋转刮起板能将附着在罐壁上的浸膏完全清理干净，降低了消耗，保证了出膏率。
5、旋转刮板使真空浓缩罐的清洗更方便、快捷、彻底。
三、重要技术参数：四、结构及性能：1、本设备由浓缩罐、搅拌系统组成。
加热采用夹套简介加热。
2、筒盖采用半开式，易清洗，易投料。
3、设备易损件：A、四氟刮板；五、工作原理：生蒸汽进入浓缩罐夹套，将料液加热沸腾，物料中水分或其它有机物体汽化，从而达到汽液分离，蒸发室蒸发出来的蒸汽经除沫器消除泡沫后由冷凝器与冷却器冷却成液体进入贮液桶，最后不凝气体排入大气或真空泵带走，该设备没有冷凝系统及真空系统，其它直接排出。
六、操作规程：1、操作前必备工作：⑴.操作前应检查设备、阀门、仪表是否正常，管路是否畅通，是否有漏。
无异常，方可清洗设备。
⑵.检查罐体是否清洗干净。
⑶.检查各阀门是否处于正确的启闭位置。
复检无误后，方可操作使用。
2、开车：⑴.开启搅拌电源；⑵.开启进料阀进料，待液面到达筒体高度的2/3处，即关闭进料阀；（3）.缓缓开启蒸汽阀门。
单效浓缩器工作原理
单效浓缩器是一种常用的热力设备，它通过蒸汽的加热作用将液体中的溶质浓缩，是化工生产中不可或缺的设备之一。
那么，单效浓缩器是如何工作的呢？接下来，我们将详细介绍单效浓缩器的工作原理。
首先，让我们来了解一下单效浓缩器的结构。
单效浓缩器通常由加热器、蒸发器、冷凝器和真空泵等部件组成。
在工作时，首先将待浓缩的液体物料送入蒸发器中，然后通过加热器提供的热能，使液体物料受热蒸发，产生蒸汽。
接着，将产生的蒸汽送入冷凝器中，通过冷凝器的冷却作用，将蒸汽冷凝成液体，最后通过真空泵将浓缩后的液体物料抽出，完成整个浓缩过程。
在单效浓缩器的工作过程中，主要依靠蒸汽的传热和传质作用来实现浓缩效果。
蒸汽在蒸发器中通过传热作用使液体物料蒸发，而蒸汽在冷凝器中通过传质作用将热量释放出来，使蒸汽冷凝成液体。
这样一来，液体物料中的溶质随着蒸汽的蒸发和冷凝不断浓缩，最终实现了浓缩的目的。
此外，单效浓缩器在工作过程中还需要借助真空泵来维持系统的负压状态，以
促进蒸汽的流动和提高蒸发效率。
同时，单效浓缩器的加热器也需要提供足够的热能，以保证蒸发过程的顺利进行。
因此，在实际运行中，需要对单效浓缩器的各个部件进行合理的调节和控制，以确保其正常、高效地工作。
总的来说，单效浓缩器通过蒸汽的传热和传质作用，实现了液体物料的浓缩。
在工作过程中，各个部件需要协调配合，确保整个系统能够稳定、高效地运行。
希望通过本文的介绍，能够使大家对单效浓缩器的工作原理有一个更加深入的了解。
