蒸馏水机多效及热压式蒸馏技术课件

1、生产WFI的多效及热压式蒸馏技术TEST 项目LIMIT 限度Conductivity 电导USP: 1.3 S/cm at 25CEu Ph: 1.1 S/cm at 20CpHUSP/EuPh: 5.0 to 7.0Aerobic Bacteria 需氧菌USP/EuPh: 10 CFU/100 mlTOC 总有机碳USP/EuPh: 500 ppmC Bacterial Endotoxin 细菌内毒素USP: EU/ml 0.25 Eu Ph: IU/ml 0.25 Nitrate (NO2) 硝酸盐USP: -Eu Ph: 0.2 ppmHeavy Metals 水重金属USP: -E

2、u Ph: 0.1 ppm as PbThe water for injections didnt always held the same characteristics over the time and countries. Some countries still use PW (from “cold” systems such as RO). Other countries changed this norm recently, understanding that the thermal treatments are absolutely crucial; for chemical

3、s cut, but overall for deep bacteriological fall. The bacteriological content in PW is 10 times higher than the WFI one, for both USP and EuPh. It should be emphasized that: USP (USA) : just from ed. 27th defined the WFI as water purified by Distillation or () superior in distillation in removal of

4、chemicals and microorganisms.EUPh (EU): Always considered W.F.I. as DISTILLED WATER注射用水的标准和定义许多年以来，在不同国家，WFI的特性及标准并不完全相同，有些国家仍采用反渗透类技术所制的纯化水。有些国家近来改变了标准，他们认识到，热处理对去除化学，尤其是微生物相关的杂质至关重要。美国药典及欧洲药典，在纯化水中，微生物类杂质比注射用水高10倍以上。应当强调：美国药典：只是从27版起才优先采用蒸馏作为将水纯化，去除化学及微生物，得到WFI的手段欧洲药典，注射用水只能由蒸馏制得Which technologies

5、 can produce W.F.I.?ISPE (International Society for Pharmaceutical Engineering), indicates 3 possible technologies to produce WFI:Single-Effect (SE)Multiple-Effect (ME)Vapor Compression (VC)IN LPH4 - 40095 11.000400 22.000 (*)WFI Temperature range/Options, C80-10037 100- Ambient- 80 100- Combination

6、 Ambient/hot(*) NOTE: For productions over 10.000 lph is suggested to split the capacities, not overpassing the 10 tons each machine, in order to have a safer job: Having the possibility to work with one VC, in case of lower production required; with consequent lower consumption. No taking risks of

7、complete production stop, in case maintenance, as it will be possible to work with the other autonomous machine/s. 采用什么技术可以生产注射用水？ ISPE指出：有三种制备方法单效蒸馏；多效蒸馏及蒸汽热压法注射用水温度可选范围环境温度；80-100，热的环境温度能力：L/时产量超过1万升时，要考虑能力的划分，为保证安全运行，每个设备不要超过10吨。如果生产量比较的低时，可采用热压式蒸馏水机，它的消耗量也比较小。如因维修要避免停产的风险，也可使用其它独立的设备。VC Distilla

8、tion Technology; History:The WATER DISTILLATION TECHNOLOGY WAS IN INVENTED IN 1908 IN ITALY, and was based on VAPOR COMPRESSION, the use was mainly for desalination purposes; just after WWII, VC found application in pharmaceutical field too. Until the end of the 80s, in Europe the VC technology was

9、not subjected to developments, as the old firms were unable to meet the improved quality requirements of the market; indeed, the VC production were stopped for several years.In the 90s, BRAM-COR spa, improved the old VC technology, with the creation of a new patented multistage compressor, reaching

10、the title of “LABORATORY OF RESEARCH FOR WATER TREATMENT SYSTEMS” given by the Italian Ministry Of Instruction, University and Research. The highest technology on the market, allowed the achievement For BRAM-COR of the European leadership in this technology.VC is currently taking market shares again

11、st the ME in the Pharmaceutical and Biotech companies, in the world, thanks to its low operational cost.热压式蒸馏水技术的历史此技术1908年发明于意大利；它基于蒸汽的压缩，主要用于脱盐；后来发现它还可用于制药行业。在欧洲，热压式蒸馏水技术没有怎么发展，因为一些老的公司无法满足市场对质量的要求，这一情况直到80年代末：热压式蒸馏水技术确实有好几年没有发展在90年代，我们公司改善了热压式蒸馏水技术，有了多步压缩机的专利，获得了意大利建设、大学及研究部颁发的“水处理系统研究实验室”的头衔。.这一

12、技术投放市场，使我们公司在欧洲获得了领先的地位。由于运行费用低，热压式蒸馏水在制药及生物技术领域取得了多效蒸馏水机的市场份额。Some old firms try to get benefit from BRAM-COR success, re-entering the market with just marketing operations, declaring “NEW VC” stills, when are nothing more than a MIX OF ANTIQUATED AND INEFFICIENT VC machines, re-assembled without a

13、ny added value.Other VCs are NOT BORN TO BE “PHARMACEUTICAL”, as the HORIZONTAL (knotty, not natural and not green), born for desalinization in the sea-boats. Its structure is in fact the FORCING OF THE CIRCULATION, so it requires many AVOIDABLE DEVICES as; sprays, re-circulations pumps, etc. (subje

14、cted to breakages, as all mechanisms), consequently this type needs more frequent interventions, spares changes, and VERY PURE FEED WATER (in contrast with the benefit that vc technology allows against me stills).Some VCs use VERY FAST COMPRESSOR ROTATION (OVER 10.000 RPM) with the consequent STRESS

15、 OF THE IMPELLER AND SHAFT, that become subjected to criticism, breakages and reduced life. In the worst cases VCs also use the DIRECT COUPLING with LUBRICATING OIL CIRCUIT (DIRTY) AT THE SAME LEVEL OF THE CIRCUIT OF THE PS (CLEAN-PHARMACEUTICAL) causing risk of CROSS CONTAMINATION, especially when

16、the VCs are designed in the ARCHAIC VACUUM CONFIGURATION (In these machines is visible a “conduit” in the shaft area, closed to the impeller, to discharge the oil arrived to the WFI circuit)VC Distillation Technology. Varieties & Types:热压式蒸馏水技术：种类和类型 有些老的公司力求从Bram公司的成功中获益，依靠市场运作再次进入市场，他们声称”新的热压式蒸馏水机

17、“，只不过是将陈旧及无效的热压式蒸馏水机混合组装，并无新意。有些热压式蒸馏水机不是药用级的，是用于出海船只非同一级别的 它的结构重点是循环，它需要许多可省的部件，如喷雾、循环泵等（因全是机械性的，易损），经常要干预，更换部件，（与多效蒸馏水机相比）供水要求高。 有些热压式蒸馏水机采用高速压缩机（超过1万/分），对叶轮及轴造成很大负荷，易成为致命点，损坏/停车及缩短寿命。在极糟糕情况下，热压式蒸馏水机连接器与润滑的回路（脏的）及药用级回路处同一水平上，导致交叉污染的风险，设计采用老式的真空结构，尤其严重。这类设备在轴的位置，靠近叶轮处，油会进入蒸馏水回路。Why the distillers p

18、re-treatment is needed?Extracts by ISPE:All distillation units are susceptible to scaling (Hardness, Silica), corrosion (Chlorine), if the appropriate feed water pre-treatment is not provided. VC operate slightly above atmospheric pressure, and the removal of calcium and magnesium, by way of water s

19、oftening, is normally required. ME stills operate at a much higher pressure and temperature, and require higher quality feed water in order to prevent scaling and corrosion. Distiller feeding through Double Pass RO (or RO+EDI)? Or just through Softening (or single RO)?OR为什么蒸馏水机需预处理？ ISPE摘录的内容：热压式蒸馏水

20、机运行稍高于大气压，通常需要通过软化来去除镁、钙。所有的蒸馏水机易结垢（硬度及硅），氯对它有腐蚀。多效蒸馏水机运行的温度和压力要高得多，对水的质量要求也高，以防止结垢及腐蚀。供水通过二级反渗透（或RO+EDI）或只是软化（或一级反渗透I）Multiple Effect pre-treatment:General pre-treatment characteristics requirements for Multiple-Effect: TDS: 5 - 10 mg/l, Silica 1 mg/l, Hardness: 0, Chlorine: 0, Ammonia: 0.NOTE: To

21、reach this kind of result it is always recommended to use water treated by RO/RO or RO/EDI.Softened water is not possible.RO/EDI (DI)Multiple Effect StillRO/ROSource 源水orTypical pre-treatment for Multiple Effect Still (ME) 多效蒸馏水机典型的处理Softening, Ca, Mg Removal多效蒸馏水机预处理多效蒸馏水机预处理的一般项目总有机碳硅硬度氯氨要达到这一要求始终

22、建议采用反渗透/反渗透或反渗透/电去离子，软化水是不可能达到要求的。软化，去钙镁多效蒸馏水机反渗透/电去离子或反渗透/反渗透General pre-treatment characteristics requirements for Vapor Compression (VERTICAL TYPES for Horizontals is suggested the complete one as per Multiple Effects): TDS: Not Considered- Silica 75 mg/l, Hardness: 2 ppm (CaCO3), Chlorine: 0, Am

23、monia: 0.NOTE: To reach this result it is possible, depending from the raw water analysis, to use tap water removed from the Chlorine (Sodium Meta Bi-Sulphite dosage) and softened (Softeners) as base; in any case a basic single pass RO is normally enough for VC feeding.Softened water or Single Pass

24、RO only, is possible (Money Saving!) Vapor Compression pre-treatment :Softening, Ca, Mg RemovalVapor Compression StillSourceChlorine RemovalPossible pre-treatment for Vapor Compression Still (VC) 热压式蒸馏水机可选的水处理程序热压式蒸馏水机的预处理直立式热压式蒸馏水机对水的预处理要求如下：（水平热压式蒸馏水机则完全与多效蒸馏水机一样）不考虑硅硬度：指折碳酸钙氯铵 根据所用源水检验的结果，自来水去氯（焦

25、亚硫酸钠）和软化（软化剂）有可能达到这个结果；在许多情况下，一个单一的反渗透处理，足以向热压式蒸馏水机供水为节约费用，可用软水及一级反渗透源水去钙镁软水脱氯热压式蒸馏水机Vapour Compression StillVC is a distillation method where water is evaporated inside, or outside, a bank of tubes arranged in vertical (NATURAL CIRCUIT), or horizontal (FORCED CIRCUIT) configuration. The VERTICAL de

26、sign is of the NATURAL CIRCULATION TYPE (the vertical configuration consents a first natural separation between steam and particles by gravity).The HORIZONTAL design is the FORCED CIRCULATION TYPE WITH RE-CIRCULATION PUMPS AND SPRAY NOZZLES (the horizontal configuration doesnt consent an optimized n

27、atural gravity separation).VC operate with plant steam at only 3 Bar (or less).VC can be heated by: Steam, Electricity or both.No need any cooling water (no Chiller/Tower investment, no operational costs).The WFI came out in pressure (ab. 1,2 barg).热压式蒸馏法有水在内部或外部蒸馏，设置一立式（自然循环）或水平式（强制循环）的多管贮罐直立式设计是自然

28、循环型（粒子与蒸汽之间由重力实现分离） 直立式设计是自然循环型（粒子与蒸汽之间由重力实现分离）；水平型是强制循环，有循环泵及喷嘴，难以实现最佳的重力分离热压式蒸馏水机的运行通常的只要3巴（或还可更低些）热压式蒸馏水机的加热方式：蒸汽、电或二者热压式蒸馏水机不需要冷却水及或冷却塔的投资，无此运行成本注射用水的出水压力（绝对压为1.2巴）ADVANTAGES:Low industrial steam consumptionLow industrial pressure (only 3 bar or less)No cooling water Max flexibility (WFI at any

29、temperature / Heating by steam and/or electricity)Efficient elimination of incondensable gasesWFI pressurized output (around 1,2 bar)Low feed water pressure (from 0,5 to 1 bar)Possibility to feed the machine with softened or single RO water (Depending from raw water)Safe design (in pressure, no risk

30、s of cross contamination, as in the old vacuum design)DISADVANTAGES:No Pure Steam production in pressure 121C (Not completely true: BRAM-COR, UNIQUE COMPANY IN THE WORLD TO PROVIDE PS 121C IN PRESSURE FROM VC. Currently available on lab. mod).Little maintenance (every 8-9.000 of work, 2 shaft bearin

31、gs w/ their seals should be changed. Total: 4 hours of job every ab.2/3 years, depending from shifts number per day).Vapor Compression热压式蒸馏水机优点 工业蒸汽消耗低压力低：3巴或更低压力无冷却水灵活性好：任何温度/蒸汽加热或电加热有效去除冷凝水 注射用水压出时，约1-2巴 进水压力0.5-1巴根据源水情况，可用软水或一级反渗透水 安全设计（压力、无老设计中有的无交叉污染）缺点 纯蒸汽不要在121度下生产（不完全是这样：BRAM也有世界上独一无二的公司，用热压

32、式蒸馏水机，在121度下生产实验室纯蒸汽的设备，在市场可供选用。Example of VC able to produce also COLD WFIVapor Compression Still热压式蒸馏水机注射用水出进水源水进排放排放工业蒸汽回收冷凝水能生产冷注射用水的热压式蒸馏水机示意.DISCHARGEINCONDENSABLE GASESRAW WATER INLETINDUSTRIAL STEAM / ELECTRICITYCONDENSATE RECOVERY / ELECTRICITYFEED WATER INLETWFI OUTLETDISCHARGEVapor Compre

33、ssion StillWET STEAM DRY PURE STEAM1 THERMAL EXCHANGE2 THERMAL EXCHANGE3 THERMAL EXCHANGECOMPRESSOR ROTATIONINCONDENSABLE GASES STRIPPING OUT PUMPVC蒸馏水机WFI出进水原水进排水不凝性气体湿蒸汽干蒸汽压缩机工业蒸汽/电冷凝水回收电/蒸汽热交换1热交换2热交换3NEW BRAM-COR COMPRESSORThe heart of the VC technology is the Compressor. BRAM-COR has currently

34、the most developed compressor technology for pharmaceutical applications in Europe. This Top Quality Level, recognized by the Italian government, was reached mixing the knowledge of our old engineers generation, that created the first VC technology in the world, together with the energy and the mode

35、rn attitude of our new engineers age group, both cooperating with two of the main Italian Universities in this field.The obtained result is the most advanced VC technology, that consented to BRAM-COR to earn the title of:新的BRAM压缩机压缩机是热压式蒸馏水机的核心BRAM最近开发了压缩机是热压式蒸馏水机的压缩机它的高水平由意大利政府认可，是热压式蒸馏水机老一代工程师及新一代

36、工程师创新精神与这个领域中二个意大利大学合作的结晶。最现代化的热压式蒸馏技术的获得，使BRAM公司获得了“工业研究实验室”的荣誉证书。Vapor Compression: Compressors GearingCURRENT IMPROVED DESIGN:BELTS TRANSMISSIONEFFICIENT & CLEANOutmoded OLD Design:DIRECT COUPLINGSHAFT STRESS, RISK OF CROSS CONTAMINATIONThe BELTS TRANSMISSION benefits are: Easy maintenance (simpl

37、e access to seals and bearings). Strongest (bearings on both the shafts edge). Less shaft solicitations (the shaft is held in both the sides). Littler occupied space (the motor can be placed under the compressor). Littler compressor (possibility to set mechanically the rotation speed). Lower consump

38、tion (littler compressor and speed setting). Clean Pharmaceutical system (motor and compressor circuits are in separated levels NO RISK OF CROSS CONTAMINATION. NO OIL CLOSED TO THE PURE STEAM CIRCUIT.Belt Transmission Detail热压式蒸馏水机：压缩机的齿轮现行改进设计：皮带传动，有效干净老的设计：直接连接，轴负荷大，有交叉污染风险皮带传动细节易维修，方便处理密封及轴承轴承的二边

39、牢固轴的二侧承负荷占地方小小压缩机（能机械设定转速）接近蒸汽处没有油清洁制药系统，马达及压缩机回路水平分开低消耗（机小，可调速）Control Systems - SCADAPharmaceutical control SCADA SUPERVISOR. SCADA, that is the acronym for Supervisory Control And Data Acquisition, refers to a large-scale, distributed measurement (and control) system. SCADA systems is used, in th

40、e pharmaceuticals process to monitor, to control, manage, print and RECORD water supply systems, or other lines. This SUPERVISOR is conform to US FDA and CFR 21 chapter 11.A SCADA system includes input/output signal hardware, controllers, HMI, networks, communication, database and software.Host cont

41、rol functions are almost always restricted to basic site over-ride or supervisory level capability (Passwords Levels).SCADA foresees statistical pages as historical trends of conductivity/pressure/T and to record and display bar graph, histograms and alarms控制系统supervisory control and data acquisitio

42、n （system） ） 制药控制监控与数据采集（系统） 此系统用于制药工艺控制、管理和打印供水系统及其它生产线的情况 符合FDA及CFR 21 11的要求 制药控制监控与数据采集（系统）包括输入/出，硬件、数据库及软件等有主机功能控制管理，密码级别设置等此系统可作统计分析，以不同方式方式显示结果SCADA SUPERVISOR on Stills:On the TOUCH SCREEN the software shows and record, for example, the following data of the line:- pressures,- levels ,- condu

43、ctivities,- pharmaceutical water T,- possible faults,T of the feed water, feed water pumps control ,- sanitary valves control,- heating steam temperatures,- effective hours of operation,- date and time of beginning/end of sanitation stage,- date and time of starting/stopping of the plant,- capabilit

44、y to adjust the parameter printing pauses,- capability to adjust the plant s sanitation cycle time,- printing all the alarms, with relative date and time.VC StillME Still热压式蒸馏水机的监控与数据采集（系统）屏上的在线数据：压力水平电导制药用水可能故障进水温度卫生阀控制加热蒸汽温度有效运行时间清洁开始的日期、时间加热蒸汽温度系统起止时间PARAMETERS 参数MULTIPLE 显著 多效EFFECTVAPOUR 热压式蒸馏水

45、COMPRESSIONOUPUT FLEXIBILITYfixed output capacitycapacity ranging from 0 to max. cap of the stillTEMPERATURE FLEXIBILITYWFI output 90/95CWFI output from feed water T + 10C till 85/90CHEATING MEDIA FLEXIBILITYindustrial steamindustrial Steam and/or electricityCOOLING WATERhigh consumption depending on qty of columnsno cooling water requiredFEED WATERSIO2 1 ppm, amines free