Experimental Investigation of Production Behavior of Methane

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Experimental investigation on capillary force of composite wick structure by IR thermal imaging cameraYong Tang,Daxiang Deng *,Longsheng Lu,Minqiang Pan,Qinghui WangSchool of Mechanical and Automotive Engineering,South China University of Technology,Wushan Road,Guangzhou 510640,Chinaa r t i c l e i n f o Article history:Received 1January 2009Received in revised form 3October 2009Accepted 19October 2009Keywords:Composite wick Meniscus Heat pipes Capillary forceIR thermal imaginga b s t r a c tA novel sintered–grooved composite wick structures has been developed for two-phase heat transfer devices.With ethanol as the working fluid,risen meniscus test is conducted to study the capillary force of wick structures.Infrared (IR)thermal imaging is used to identify and locate the liquid meniscus.The effects of sintered layer,V-grooves and powder size on capillary force are explored.The results show that the capillary force of composite wick structures is larger than that of grooved and sintered ones.Interac-tion wetting between groove and sintered powder happens during the liquid rise in composite wick,which provides an additional source of capillary force.It exhibits a variation of capillary force of compos-ite wicks with different powder size due to the difference of open pore size and quantity in sintered por-ous matrix.Ó2009Elsevier Inc.All rights reserved.1.IntroductionDevelopment of heat pipes,vapor chambers and capillary pumped loops (CPL)is motivated by the thermal management of electronic components.These heat transfer devices work via two-phase flow.By evaporation and condensation,heat is transported from one end to the other or spread to a large area.Two-phase heat transfer devices consist of a number of components,such as evap-orator,wick and condenser.The wick shows great effects on the heat transfer performances of these devices.Wick structures are generally grooved or sintered.Sintered wicks have large capillary force but low permeability,while grooved wicks have high perme-ability but small capillary force [1].Capillary force and permeabil-ity are somehow contradictory in a single wick.However,composite wicks can balance these two competing factors and im-prove heat transfer performances.Currently,researches have been focused on composite wick structures [2–4].Hwang et al.[2]ob-tained modulated composite wicks by making grooves over a thin uniform porous layer.The modulated composite wick improved heat transfer performance by providing extra cross-sectional area for enhanced axial capillary liquid flow and extra evaporation sur-face area.Wang and Catton [3]investigated a composite structure with a thin porous layer on the triangular groove.It was found that evaporation heat transfer in the composite structure was three to six times higher than that in the groove without a porous layer.Capillary force of wick plays the driving force of the circulation of working liquid in two-phase heat transfer rge capil-lary force makes these devices work well.Capillary force of wick has been determined mainly through two methods.One is the bub-ble point test [5].Pressurized gas is applied to one end of a wick saturated with liquid.With the pressure gradually increasing,the point that bubbles appear on the opposite end of the wick is re-corded for the capillary force.The other method is the risen menis-cus test [6,7].One end of a wick is dipped into the working liquid.Then the liquid level rises in the wick sample until the pressure on both sides of the meniscus equilibrates.Nowadays,the latter method has been widely used due to its convenience.Chen et al.[8]observed the liquid fronts in the inclined wick by optical micro-scope (OM)and CCD camera.Holley and Faghri [9]obtained the closed form solution of effective pore radius and permeability of wicks by sight and weight change.Nevertheless,visualization of the meniscus by sight may be not accurate because most of the working liquid is colorless and transparent.In the case of micro grooved or sintered wick structures,it is difficult to locate the meniscus.This problem may be solved with the technique of infra-red (IR)thermal imaging.IR thermal imaging can provide accurate and non-contact measurement of temperature field [10].It has been used for the test of thermal performance and heated flow of liquid film of two-phase heat transfer devices [11–15].Due to the infrared emissivity difference between wick samples and working liquid,the meniscus can be accurately located by IR ther-mal imaging.Thus,the rising of the wetted height driven by capil-lary force can be investigated.0894-1777/$-see front matter Ó2009Elsevier Inc.All rights reserved.doi:10.1016/j.expthermflusci.2009.10.016*Corresponding author.Tel./fax:+862087114634.E-mail address:dengdaxiang88@ (D.Deng).Experimental Thermal and Fluid Science 34(2010)190–196Contents lists available at ScienceDirectExperimental Thermal and Fluid Sciencejournal homepage:www.else v i e r.c o m /l o c a t e /e t fsThe present study proposes a novel sintered–grooved compos-ite wick structure by covering a layer of sintered copper powderon micro V-grooves.With the risen meniscus test method,the cap-illary force of the wick is investigated by the visualization of IR thermal imaging camera.2.Experimental2.1.Fabrication of composite wick structureSintered–grooved composite wick structure is shown in Fig.1.Micro V-grooves were made in copper base with the thickness of 1.0mm.Then copper powders were sintered on the grooves.Dur-ing sintering,adhesion and mass transfer happened by the driving of surface tension.Different powder particles bonded together.Due to the same material of copper,powder particles and groove fins also partially bonded together,as seen in Fig.2.Thus,sintered–grooved composite wick formed.The copper powders (supplied by ACuPowder International,LLC,USA)are of irregular morphol-ogy,with purity of 99.3%,produced by water atomization method [16].To optimize the sintered powder size,four composite wick samples were made.A grooved sample without powder and a sin-tered sample without grooves were also studied for comparison.For the sintered sample,a 0.5mm thick powder layer was sintered on 1.0mm thick copper base .All the samples had the same dimen-sions,with length 100mm and width 10mm,as shown in Table 1.Copper powder layer was sintered at temperatures 950±10°C in a tube furnace for half an hour under a reduction stream of 10%hydrogen and 90%argon.2.2.Experimental apparatusAn apparatus of the risen meniscus test is set up to determine the capillary force of wick structures,as shown in Fig.3.It consists of vertically adjusting device,sample fixing device,reservoir,IR thermal imaging camera,glass cover with a hole for IR thermal imaging visualization,PLC controller and PC.The classical working liquid,ethanol,is used in the experiment.At first,test sample is fixed in vertical in the sample fixing device.Secondly,the sample moves down to dip into ethanol by the vertically adjusting device in a constant speed.The dipped length of samples in the liquid is 2mm.At last,IR camera records the meniscus rising process in 1min from the point that the sample just dips into ethanol.Ambi-ent temperature is 30°C.The glass cover is used to ensure the cir-cumstance airflow stable.The volatilization of ethanol is in a constant speed.Therefore,the difference between samples can be observed accurately.2.3.Meniscus locating method in IR thermal imagingA FLIR ThermaCAM SC3000IR camera was used with a thermal sensitivity of 0.02K at 30°C and an accuracy of 1%for tempera-tures below 150°C of the full scale.The back-side of the samples was painted black to provide a uniform emissivity.Due to the infrared emissivity difference between copper and ethanol,differ-ent temperature distributions between samples and ethanol were displayed in IR thermal images.The meniscus could be accurately located as follows.As shown in Fig.4,a measuring line was drawn along the sample from the fixing device to the dipping end.It stoodNomenclature D powder size,l mg gravity acceleration,m/s 2h capillary wetted height,mm h g depth of grooves,mmh t height of total grooves,mm K permeability,mm 2M mass of powder,gr eff effective pore radius,mms spacing interval of grooves,mm T thickness of wick,mm wwidth of grooves,mmGreek symbols4P capcapillary force,Pa 4P cap ,com capillary force of composite wicks,Pa4P cap ,sin capillary force provided by sintered porous zone,Pa 4P cap ,gro capillary force provided by groove bottom zone,Pa 4P cap ,int capillary force provided interaction wetting zone,Pa e porosity,dimensionless l dynamic viscosity,Pa s h liquid–solid contact angle,rad q density,kg/m 3r surface tension,N/mFig.1.Schematic of sintered–grooved composite wickstructure.Fig.2.Sintered bonding of composite wick structure.Y.Tang et al./Experimental Thermal and Fluid Science 34(2010)190–196191for the sample and its length had been measured before the sample dipped into ethanol.A locating point was added in the measuring line.As this point moved vertically along the measuring line,the vertical line moved along the temperature distribution curve until arriving at the inflection point.The position of this inflection point stood for the meniscus.The height result of the point could be cal-culated.Thus,the wetted height,h ,was obtained.Besides,the wet-ted height over time during the whole visualization process could be accurately obtained.Thus,the rising velocity of wetted height could be also studied.3.Analysis of liquid flow characteristic in composite wick structureDuring the risen meniscus test,working liquid rises in a wick.The following assumptions are given:(i)steady-state laminar flow in the wick,(ii)uniform saturation with liquid along the wetted length and (iii)neglecting inertial effects and evaporation of liquid.In the initial time after the composite wick dips into ethanol,the liquid rises along two channels,micro groove and sintered por-ous layer.In the groove channel,liquid flows along a straight line on the groove surface,whereas in the sintered porous channel,li-quid flows tortuously by the open pores in sintered porous layer.The friction resistance of liquid flow in groove is smaller than that in sintered porous layer.Therefore,the liquid rises faster in the groove channel than in the sintered porous layer.However,there are small voids which interconnect the groove and sintered porous layer (Fig.2).The liquid in the groove channel and sintered porous layer does not flow separately.There is an interaction effect be-tween these two rising channels,that is,the fast liquid in groove channel drags the slow liquid in sintered porous layer.By this interaction effect,the liquid in these two channels converges to-gether and a balanced rising velocity reaches between groove and sintered porous layer.We name this kind of flow in composite wick as interaction wetting.It is somewhat similar to the plate-particle interaction during water saturation in the channels with particles in contact with a plate of the same material,which was analyzed by Lechman [17].Due to the interaction wetting,the composite wick is completely saturated except the closed poresTable 1Samples code and specifications.Sample code Powder size,D mm Mass ofpowder,M g Thickness of wick,T mm Height of total grooves,h t mm Spacing interval of grooves,s mm Depth of grooves,h g mm Width of grooves,w mm Porosity,e (%)Grooved ––– 1.360.80.650.85–Sintered 80–110 2.00 1.5––––55C40–6040–60 2.00 1.5 1.360.80.650.8554C60–8060–80 2.00 1.5 1.360.80.650.8554C80–11080–110 2.00 1.5 1.360.80.650.8554C110–140110–1402.001.51.360.80.650.8554Fig.3.Schematic of the risen meniscus testapparatus.Fig.4.Meniscus locating method of wick structure in IR images (sample:C110–140).192Y.Tang et al./Experimental Thermal and Fluid Science 34(2010)190–196in sintered porous layer.The interaction wetting repeats as the li-quid rises in wicks until a final equilibrium height reaches.As shown in Fig.5,the composite wick can be mainly divided into three parts for liquid flow,sintered porous zone,groove bot-tom zone and interaction wetting zone.Each flow zone provides a source of capillary force.Thus,we can obtain:D P cap ;com ¼D P cap ;sin þD P cap ;gro þD P cap ;int ð1Þwhere D P cap ,com is the capillary force of composite wicks,D P cap ,sin ,D P cap ,gro ,and D P cap ,int is defined to be the capillary force provided by sintered porous zone,groove bottom zone and interaction wet-ting zone,respectively.It should be noted that D P cap ,int is induced by the drag force of the fast liquid in groove,which acts on the slow liquid in sintered porous layer.4.Results and discussionsFor the rise of liquid during the risen meniscus test,capillary force of the wicks,D P cap ,plays the driving force.The total pressure loss,D P total ,plays the flow resistance,which consists of two parts,friction pressure loss and hydrostatic pressure loss,as follows:D P total ¼l e K h d hd tþq ghð2Þwhere l is the viscosity of working liquid,e is the porosity of wick structure,K is the permeability of wick structure,h is the wettedheight,d his the rising velocity of the wetted height,q is the liquid density,g is the gravitational acceleration.Because of the neglect of inertial effects,these are the only source of pressure change dur-ing the liquid rise.Thus,capillary force is equal to the total pressure loss:D P cap ¼l e h d hþq ghð3Þtherefore,the capillary force of different wicks can be compared byh and d hof liquid rise.For different wicks during the same test time,the sample with larger wetted height and rising velocity has larger capillary force.4.1.Effect of sintered layer on capillary forceAs can be seen in Fig.6,the liquid in all samples rose quickly at the early time of the rise process.As the wetted height increased,the rising velocity of the wetted height reduced -pared with the composite samples,the grooved sample had higher rising velocity in the first 15s.Without sintered powder in grooves,the friction resistance of liquid flow was small.Ethanol rose very fast in the grooves.The wetted height reached 30mm at 15s and the equilibrium height was obtained at 30s.After that the meniscus did not rise.While in the composite samples,the meniscus rose continuously for a longer time than grooved wick.The equilibrium height had not yet been obtained at the end of one minute.Fig.7shows the meniscus rising process of a compos-ite wick by IR thermal images.At the end of the test time,the wet-ted heights of all the four composite samples were larger than grooved wick.It can be concluded that composite wicks had larger capillary force than grooved one.This can be attributed to the anal-ysis in Wang’s report [3].Capillary force can be also obtained by the Laplace–Young equation as defined below:D P cap ¼2r r effð4Þwhere r is the surface tension of liquid and r eff is the effective cap-illary radius.As the sintered layer covered the grooves,a lot of small menisci formed in the sintered layer.The effective capillary radius decreased from the radius of big meniscus of the groove in grooved wick to the radius of small menisci in the sintered layer in compos-ite wick.Thus,from Eq.(4),the capillary force of composite wicks was larger than that of grooved one.Meanwhile,as analyzed in Sec-tion 3,from Eq.(1),sintered powder layer and interaction wetting provided two additional important portions of capillary force for composite wick.Thus,composite wicks have larger capillary force than grooved one.4.2.Effect of V-grooves on capillary forceA sintered sample,which has the same powder size with com-posite sample (80–110l m),was tested for comparison.The result was shown in Fig.8.During the first 10s,the wetted height andtheFig.5.Schematic of three liquid flow zones in a compositewick.Fig.6.Effects of sintered layer and powder size on wetted height of wicks.Y.Tang et al./Experimental Thermal and Fluid Science 34(2010)190–196193rising velocity were almost equal for both sintered and composite sample.It is due to that the capillary force difference between these two samples was small.Sintered porous layer in both wicks provided large capillary force for liquid rise.As the wetted height grew,the rising velocity reduced gradually.During this time,the capillary force difference between these two samples played an important role in liquid rise.Results show that the wetted height and the rising velocity of composite sample were larger than thatof sintered sample after 10s.It resulted from that the groove bot-tom zone and interaction wetting zone provided additional sources of capillary force for composite wick.Besides of the capillary force provided by sintered porous layer,the driving force of groove bot-tom zone and the drag force in interaction wetting zone increased the total capillary force of composite wicks.Thus,the capillary force of composite wick is a little larger than that of sintered wick.4.3.Effect of powder size on capillary force of composite wicks Experimental results in Fig.6shows that the wetted height of sample C80–110is the largest.Following was C110–140and C40–60.The smallest was C60–80.The rising velocity generally fol-lowed a similar order.Thus,the composite sample with the 80–110l m powder had the largest capillary force.It could be found that the capillary force of composite samples with large powder size (C80–110and C110–140)was larger than that with small powder size (C40–60and C60–80).This is mainly due to the porous matrix difference of composite wicks.As shown in Table 1,identi-cal porosity was obtained for these four samples.According to the definition of porosity [18],the volume sum of open pores and closed pores equaled for the samples,due to the same volume of the sintered layer in these four composite wicks.However,as shown in Fig.9,the open pore size and quantity varied,which strongly affected the liquid flow in wick structures.In porous ma-trix,only open pores could provide channels for liquid flow.Closed pores can not be saturated.Due to the existence of closed pores,li-quid would turn to flow by the adjacent open pores.Thus,theflow-Fig.7.IR images of the meniscus rising process of composite wick structure during one minute (sample:C110–140).parison between composite wick and sintered wick with the same powder size (80–110l m),wetted height versus time.194Y.Tang et al./Experimental Thermal and Fluid Science 34(2010)190–196ing channels became longer and the friction resistance of liquid flow increased.For the samples with small powder size (samples C40–60,C60–80),the voids among powder particles were apt to be filled or covered by other particles during sintering.A lot of closed pores existed.While for the samples with large powder size (samples C80–110,C110–140),there were larger voids among dif-ferent particles than that with small powder size.They could not be filled or covered by other particles due to their large size.More open pores formed.The open pores were bigger and they were eas-ier to interconnect with each other.Thus,there were more flowing channels for the liquid rise in sintered porous layer.The friction resistance of liquid flow was smaller.The liquid rose higher and faster.As a result,composite samples with large powder size have larger capillary force than that with small powder size.However,it was found in the experiments that capillary force does not increase linearly with powder size.It may be attributed to the difference of the interaction wetting effect.For the sample with large powder size (C80–110,C110–140),the interaction effect in sample C80–110with comparatively smaller powder size may be a little stronger in the liquid rise process,and the liquid in grooves may provide a little larger drag force acting on liquid in sintered porous layer than sample C110–140.Thus,the capillary force of sample C80–110is a little larger than sample C110–140.Similarly for the sample with small powder size,sample C40–60has slightly larger capillary force than sample C60–80.Other stud-ies,such as theoretical verification of powder size and other parameters’effects on interaction wetting,are still required in the future work.5.ConclusionsSintered–grooved composite wick has been presented for two-phase heat transfer devices.IR thermal imaging camera was usedin the risen meniscus test of capillary parison of the wetted height and rising velocity among composite,grooved and sintered wicks was conducted.Four composite wicks with different powder size ranged from 40–60l m to 110–140l m were tested.The conclusion can be summarized as follows:(1)For the infrared emissivity difference between liquid andsolid at a given temperature,the liquid meniscus in a wick can be accurately located by IR thermal images,including grooved,sintered and composite wicks.(2)Interaction wetting between groove and sintered powderhappens during the liquid rise,and composite wick can be mainly divided into three parts for liquid flow,sintered por-ous zone,groove bottom zone and interaction wetting zone.Each flow zone provides a source of capillary pos-ite wicks have larger capillary force than grooved and sin-tered ones.(3)Composite wicks with large powder size provide larger cap-illary force than that with small powder size.Friction resis-tance difference of liquid flow exists due to the variation in open pore size and quantity in different porous matrix of composite wicks.But the capillary force varies nonlinearly with the powder size.The optimal powder size of composite wick is suggested to be 80–110l m.Future work is needed for theoretically modeling of the liquid flow in composite wicks.Besides,theoretical analysis of powder size and other parameters’effect on interaction wetting and capil-lary force will be carried out.AcknowledgementsThis work is financially supported by the National Natural Sci-ence Foundation of China,Project No.U0834002andNo.Fig.9.SEM photograph of sintered porous matrix of composite samples showing variation in open pore size and quantity:(a–d)correspond to samples C40–60to C110–140,respectively.Y.Tang et al./Experimental Thermal and Fluid Science 34(2010)190–19619550705031,50975092,and Guangdong Natural Science Foundation, Project No.07118064,and No.8151064101000058.References[1]I.Sauciuc,M.Mochizuki,K.Mashiko,Y.Saito,T.Nguyen,The design and testingof the superfiber heat pipes for electronics cooling applications,in: Proceedings of16th IEEE Semiconductor Thermal Measurement and Management Symposium,San Jose,USA,2000,pp.27–32.[2]G.S.Hwang,M.Kaviany,W.G.Anderson,J.Zuo,Modulated wick heat pipe,Int.J.Heat Mass Transfer50(7–8)(2007)1420–1434.[3]J.L.Wang,I.Catton,Enhanced evaporation heat transfer in triangular groovescovered with a thinfine porous layer,Appl.Therm.Eng.21(17)(2001)1721–1737.[4]G.Franchi,X.Huang,Development of composite wicks for heat pipeperformance enhancement,Heat Transfer Eng.29(10)(2008)873–884. [5]D.R.Adkins,R.C.Dykhuizen,Procedures for measuring the properties of heatpipe wick materials,in:Proceedings of the28th Intersociety Energy Conversion Engineering Conference,Washington DC,1993,pp.911–917. 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实验室OOS管理和案例分析做药品检验，会没有偏差吗？答案一定是否定的。

药品生产企业的检验偏差，说白了就是与检验相关的一些异常。

通常会涉及到检验的各个环节，比如进厂的物料（包括原料、辅药、包装材料等）、中间产品、待包装产品、成品、稳定性考察样品、市场投诉退货产品、环境监测、工艺用水、公用介质（如：氮气、蒸汽）、辅助生产用品（如：消毒液、手套）、辅助检验用品（如：色谱纯、鲎试剂）等。

一、检验偏差的分类1、OOS(超标）指检验结果超出设定质量标准，包括注册标准以及企业内控标准。

如果对于产品有多个接受标准，结果的评判采用严格的标准执行。

OOS是检验偏差的一种特例，说得是一种检验结果。

2、OOT（超趋势）指随时间的变化，产生的在质量标准限度内，但是超出预期期望的一个结果或一系列结果（比如稳定性降解产物的增加），或未能符合统计学控制标准。

如标准规定为5.5-7.5，测定结果通常是6.0-7.0，检验结果是5.8，则该数据构成OOT数据。

3、OOE（超预期）指实验结果超过历史的，预期的或先前的趋势/限度。

非期望结果有如下两种：一是对于同一制备的样品重复测定结果或重复制备的样品的结果显示不良的精密度，即精密度不符合规定；二是基于对实验物料、实验室样品或实验规程的了解，实验结果不正常(包括该结果虽符合质量标准，但不是正常的值)。

OOT是属于OOE的一种形式。

4、AD(异常数据)指检验数据本身可疑或来自异常测试过程的数据或事件。

结果出人意料，不规则，可疑，不正常。

如仪器设备停机，人为差错，色谱图产生意想不到的峰等产生的数据或事件。

5、检验偏差偏差指与已建立的质量标准、标准操作规程、及其他书面规程不相符合的，并与产品质量直接或间接相关的事项。

检验偏差如仪器校验过期、药品洒掉、样品成分未完全转移、样品存放条件不当、标化室温湿度超标等。

二、OOS调查（包括理化、微生物）1、OOS的由来OOS是指超出药品申请和审批文件、DMF文件 (药物主文件)、药典以及企业标准的所有检验结果，包括所有超出标准的中控过程检验数据。

Scientia Iranica B(2011)18(4),923–929Sharif University of TechnologyScientia IranicaTransactions B:Mechanical EngineeringExperimental investigation of air–water,two-phase flow regimes in vertical mini pipeP.Hanafizadeh,M.H.Saidi∗,A.Nouri Gheimasi,S.GhanbarzadehSchool of Mechanical Engineering,Sharif University of Technology,Tehran,P.O.Box11155-9567,IranReceived8November2010;revised28April2011;accepted12June2011KEYWORDSMini pipes;Two-phase flow; Flow pattern; Visualization; Flow pattern map.Abstract In this study,the flow patterns of air–water,two-phase flows have been investigated experimentally in a vertical mini pipe.The flow regimes were observed by a high speed video recorder in pipes with diameters of2,3and4mm and length27,31and25cm,respectively.The comprehensive visualization of air–water,two-phase flow in a vertical mini pipe has been performed to realize the physics of such a two-phase flow.Different flow patterns of air–water flow were observed simultaneously in the mini pipe at different values of air and water flow rates.Consequently,the flow pattern map was proposed for flow in the mini-pipe,in terms of superficial velocities of liquid and gas phases.The flow pattern maps are compared with those of other researchers in the existing literature,showing reasonable agreement.©2011Sharif University of Technology.Production and hosting by Elsevier B.V.All rights reserved.1.IntroductionGas–liquid,two-phase flow in micro structures has played an important role in several industrial and medical applications, such as micro heat exchangers,lab-on-chips,bio-MEMS and micro cooling electronics.Physical perception of micro flows is critical in order to optimize and develop the design of such devices.Two-phase flows at mini and micro scale have recently attracted the attention of scientists as a result of its wide usage in advanced science and technology,namely Micro-Electro-Mechanical Systems(MEMS),chemical engineering, bioengineering,medical devises,micro cooling systems,micro structures in computers,etc.The literature survey on this issue has been categorized into adiabatic and phase change work, which has been summarized in this paper.∗Corresponding author.E-mail address:saman@(M.H.Saidi).1.1.Adiabatic worksThe works of Suo and Griffith[1]were among the first studies concentrating on flow patterns in microchannels.They detected three different flow patterns,namely,bubbly/slug, slug and annular flow,in their studies,using channels with widths in the range of0.514–0.795mm.Sadatomi et al.[2] proposed flow regime maps in vertical rectangular channels and indicated that channel geometries have little influence in noncircular channels with large hydraulic diameters greater than10mm.Xu et al.[3]investigated concurrent vertical two-phase flow in a vertical rectangular channel with a narrow gap, experimentally.They reported that with a decrease in channel gap,the transition from one flow regime to another occurs at smaller gas flow rates.They developed a new criterion to predict transition from annular flow,as well.Hestroni et al.[4] performed experiments for air–water and steam–water flow in parallel triangular micro-channels,developed a practical modeling approach for two-phase micro-channel heat sinks and considered the discrepancy between flow patterns of air–water and steam–water flow in parallel micro-channels. Fukagata et al.[5]simulated an air–water two-phase flow in a20µm ID tube,numerically,with focus upon flow and heat transfer characteristics in the bubble train flows.He and Kasagi[6]simulated numerically adiabatic air water slug flow in a micro tube.They focused on pressure drop characteristics and their modeling.They found that the total pressure drop of a slug flow can be decomposed into a frictional pressure drop and a pressure drop over the bubble itself.Carlson et al.[7]1026-3098©2011Sharif University of Technology.Production and hosting by Elsevier B.V.All rights reserved.Peer review under responsibility of Sharif University of Technology.doi:10.1016/j.scient.2011.07.003924P.Hanafizadeh et al./Scientia Iranica,Transactions B:Mechanical Engineering18(2011)923–929investigated characteristics of multiphase dynamics,especially two-phase gas–liquid flow,by means of advanced numerical simulations.They compared two Computational Multi-Fluid Dynamic(CMFD)codes,Fluent and TransAT,and reported a prediction of recirculating flow in the bubbly flow case using TransAT,while significant recirculation was not observed in the solution using Fluent.Saison and Wongwises[8]performed a series of experiments in a horizontal circular micro channel with an inner diameter of0.15mm.They presented a flow pattern map in terms of the phase superficial velocities, and proposed a new pressure drop correlation for practical application.1.2.Phase change worksThe pool boiling heat transfer,in a vertical narrow annular with closed bottoms,was observed through a transparent quartz shroud by Yao and Chang[9],and stages of evolving boiling phenomena with an increase in heat flux were reported. Several researchers observed three basic flow patterns,namely, bubbly,slug and annular flow,in the mini pipe and channel. Damianides and Westwater[10]performed experiments with a1mm tube,and Mertz et al.[11]and Kasza et al.[12] studied the flow visualization of water nucleation in a single rectangular channel of2.5mm by6mm.Lin et al.[13]used a single round tube with2.1mm inside diameter for their experiments,and compared the flow transitions with those predicted by Bernea et al.[14].Sheng and Palm[15]performed their experiments with1–4mm diameter tubes.Cornwell and Kew[16]found three different flow patterns for R-113, namely,isolated bubbles confined bubbles and slug/annular flow,in rectangular channels with cross sectional areas of 1.2–0.9mm and3.5–1.1mm.Ory et al.[17]considered the effects of capillary,inertia,friction and gravity forces on the velocity distribution and temperature field along a single capillary two-phase flow in a heated micro-channel.Research dealing with gas–liquid,two-phase flow in micro-channels,in situations where fluid inertia was significant in comparison with surface tension,was reviewed by Ghiaasiaan and Abdel-Khalik[18].Jiang et al.[19]studied the boiling of water in triangular micro-channels,having widths of50and100µm. They observed individual bubbles at low heat fluxes,and an abrupt change in flow pattern to an unstable slug flow with increasing heat flux.Chedester and Ghiaasiaan[20]addressed the hydro-dynamically controlled Onset of a Significant Void (OSV)in heated micro tubes.They derived a simple semi-empirical correlation for the radius of departing bubbles at the OSV point to show the accuracy of their hypothesis.Some experimental studies have been reported on gas liquid two-phase flow in mini and micro conduits by Kandlikar[21],Lee and Mudawar[22]and Serizawa et al.[23].The three zone boiling heat transfer model was developed by Thome et al.[24]. Revellin and Thome[25]used an optical measurement method for two-phase characteristics of R-134a and R-245fa,in0.5mm and0.8mm diameter channels,to determine the frequency of bubbles existing in the microevaporator.They detected four flow patterns,namely,bubbly,slug,semi-annular and annular flow,whose transitions were not well compatible with neither the macroscale map of refrigerants nor the microscale map of air–water flow.Sobierska et al.[26] experimentally investigated the water boiling phenomena in a vertical rectangular microchannel,with a hydraulic diameter of0.48mm.They observed three main flow patterns,namely, bubbly,slug and annularflow.Figure1:Schematic of test apparatus.Due to the effects of surface tension,two-phase flows at mini and micro scale have different behavior in comparison with the macro scale.The aim of the present work is to visualize flow regimes in air–water two-phase flows and propose a flow regime map for such flows in vertical mini pipes.The neural network technique is implemented to recognize and predict a gas–liquid,two-phase flow pattern in mini tubes,having diameters of2,3and4mm.2.Experimental setupThis study is carried out by experimental apparatus schematically shown in Figure1.Air and water are used as gas and liquid phases in the experiments.The water flow rates are regulated by the needle valves and are measured by the cali-brated rotameter.Air and water are mixed together in a mixer made of acrylic glass and placed at the bottom of the riser pipe. The compressed air is fed by the compressor via an air injec-tor,which is schematically depicted in Figure2.The water flows from the center hole of a mixer,with a diameter of2mm,while air is injected into the holes around the center hole,each having 1mm diameter.The air flow rates are set by the regulator valve and are continuously measured by the calibrated gas rotameter. The overall height and inside diameter of the riser pipe are sum-marized in Table1.In order to have the opportunity to visually observe the two-phase flow patterns,the riser pipe was made of transparent glass.The air water mixture was directed upward through the riser,separated in the separation tank at the top of the riser and the air was discharged into the atmosphere.Differ-ent flow regime images were captured by a digital high speed camera,with a frame rate of1200fps,from the test section of the upriser.The test section is placed after the entrance section to diminish the effect of the entrance region.The length of the entrance section is about500mm.The superficial air and water velocities are0.5–10m/s and0.05–1m/s,respectively.P.Hanafizadeh et al./Scientia Iranica,Transactions B:Mechanical Engineering 18(2011)923–929925Figure 2:Schematic of air and watermixer.Figure 3:(a)RGB picture;(b)gray picture;and (c)subtracting and median process of flow in the pipe (3mm diameter).3.Experimental results 3.1.Image processingImage processing techniques must be performed in order to extract features from the images of the two-phase flow.Each picture has 8bit RGB (red,green and blue)color format,being converted from RGB to a grey scale mode.The output image has 256grey levels from 0(black)to 255(white).It is difficult to extract the bubbles directly from an original digital image and therefore preprocessing procedures must be undertaken to reduce noise and improve the quality of the images.An image-subtracted algorithm was used to reduce background noise by subtracting the background image from each dynamic image.In order to smooth the image border,a median filter was also used.A sliding window (3×3)was used in this process,and the median gray level of the pixels in the window was ter,the gray level of the pixels located at the center of the window was replaced by the median.The result of these processes is shown in Figure 3.3.1.1.Inverting binary imageThe images were converted from grayscale to binary mode by threshold segmentation,and an iterative procedure was used to calculate the optimizing threshold as follows [27]:Figure 4:Binary image of two-phase flow in the mini pipe.(a)The minimum and maximum of the gray level,namely Z land Z k ,are found in the image,and the initial value of the threshold is derived from their arithmetic average as:T 0=(Z k +Z l )/2.(1)(b)According to the initial value of threshold T K ,the imageis divided into two parts,namely,object and background,and the average value of the gray level in each part is calculated as:Z O =−Z (i ,j )<T kZ (i ,j )N O,(2)Z B =−Z (i ,j )>T kZ (i ,j )N B,(3)where Z (i ,j )is the gray level of the pixel (i ,j )in the image,N O is the number of the pixels in which Z (i ,j )is less than T K ,and N B is the number of pixels in which Z (i ,j )is more than T K .(c)The new threshold is calculated based on the arithmeticaverage of the object and background segments of the image as:T k +1=(Z O +Z B )/2.(4)If T K =T K +1,then the algorithm is finished,else K ≪=K +1,and turn to step (b).The binary image of the bubbles in the vertical pipe,which is the result of the above procedure,is shown in Figure 4.3.1.2.Image morphology processingSome morphological functions,such as dilation,erosion,opening and closing operations,were applied to modify the shapes of bubbles.Dilation adds pixels to the boundaries of the objects in an image,while erosion removes pixels on the object boundaries.The definition of a morphological opening of an image is erosion followed by dilation,using the same structuring element for both operations.The related operation,morphological closing of an image,is the reverse.It consists of dilation followed by erosion,with the same structuring element.Both of them do not significantly alter the area or shape of objects.The opening operation removes small objects and smoothes boundaries.Borders removed by erosion are restored by dilation,but small objects that were absorbed during erosion do not reappear after dilation.The closing operation was used to fill tiny holes and smooth boundaries.Objects were expanded by dilation and then reduced by erosion,so borders were smoothed and holes were filled [28,29].After926P.Hanafizadeh et al./Scientia Iranica,Transactions B:Mechanical Engineering 18(2011)923–929Figure 5:Final image of two-phase flow in the mini pipe.these operations,the result of image processing is shown in Figure 5.Bubble images of two-phase flow were clear using the above image processing,and it prepared bubbles for quantitative analysis,such as measuring area,perimeter and diameter.3.2.Flow pattern mapIn the experimental procedure while varying gas or liquid mass flow rate,a 10s film was recorded from the flow regime at a speed of 1200fps.The recorded film was replayed in slow motion for recognition of flow regimes.Each film converted to separate frames in a picture format using Adobe Premiere software.The achieved pictures were used as inputs of image processing techniques.The final binary pictures were used for the mentioned post processing procedure,such as flow regimedetection,void fraction and bubble velocity calculation,etc.Figure 6shows those typical flow regimes observed in the vertical,co-current,air–water,two-phase flows,in the 3mm mini pipe.Four basic flow patterns,namely,bubbly,slug,churn and annular,accompanied by their transitions,are illustrated in these figures.The visualization shows that air–water two-phase flows in mini pipes do not have three dimensional behaviors,especially in bubbly and slug flows.The final processed images of different flow regimes in air–water,two-phase flow in mini pipes have been presented in Figure 7.Figures 8–10show the flow pattern map for a vertical round tube with inner diameters of 2,3and 4mm,respectively.The proposed maps are in terms of superficial velocities of phases,and the four main flow patterns are depicted in these maps.In Figure 11,the achieved flow pattern for the pipe with 2mm ID was compared to the work of Ide et al.[30],shown by a solid line.They divided the flow pattern map into the four main regions,namely,dispersed bubbly flow,intermittent flow,churn flow and annular flow.The comparison shows that the bubbly and annular flows in the present work are not well in accordance with those of Ide et al.In the present work,the dispersed bubbles were not seen,because the air bubble injector did not have very thin holes.As a result,the created bubbles mostly have diameters in the range of the pipe diameter.Even the existence of air injectors with thin holes cannot guarantee the creation of bubbly flow.In the case of small bubbles occurring,as a result of thin holes in the air injector and the developed two-phase flow,they would collapse,resulting in large bubbles know as intermittent flow.Bubbly flows are mainly promoted by bubble breaking mechanisms,due to turbulence effects.It seems that in small diameter pipes,the formation of a specific flowpatterns(a)Bubbly.(b)Bubbly-slug.(c)Slug.(d)Messy-slug.(e)Churn.(f)Wispy-annular.(g)Ring.(h)Wavy-annular.(i)Annular.Figure 6:Different flow patterns in a vertical pipe with 2mm diameter.P.Hanafizadeh et al./Scientia Iranica,Transactions B:Mechanical Engineering18(2011)923–929927(a)Bubbly.(b)Slug.(c)Messy-slug.(d)Churn.(e)Ring.(f)Wavy-annular.Figure7:Final processed image of different two-phase flow regimes in the minipipe.Figure8:Flow patterns for2mm innerdiameter.Figure9:Flow patterns for3mm inner diameter.mainly depends on mixer configuration.The radial air supplierused in this study makes intermittent flow patterns,such asslug and churn flows,while the air supply in the tube centerfavors annular flow.This can be the reason for an absence ofannular flow in the proposed flow patterns.The comparison offlow patterns also reveals that the slug,messy slug andsemi-Figure10:Flow patterns for4mm inner diameter.annular flows in the proposed map are in accordance with theintermittent flow of Ide et al.[30].In the present study,a noticeable difference between flowpattern maps for vertical pipes with various diameters of2,3and4mm is not seen.This can be justified in regard tothe fact that the dominant forces acting on the air–watermixture in the small diameter pipes,namely,gravitation,inertia,surface tension and buoyancy forces,are in the sameorder of magnitude.This concept clearly indicates that thesethree flow patterns can be combined to form a new flow patternfor the gas–liquid,two-phase flow in small diameter pipes.A combination of these three flow patterns results in a newflow pattern map,which is illustrated in Figure12.A FuzzyC-Means clustering technique(FCM)was used to classify theflow patterns.The solid lines in the figure show the transitionregion of the flow patterns.This figure shows the achieved flowmap for mini pipes with diameters in the range of2–4mm.4.ConclusionIn this paper,air–water,two-phase flow patterns wereinvestigated experimentally for mini pipes with diameters of2,3and4mm.An image processing technique was used fordetection of flow patterns from pictures derived from filmsrecorded with a high speed camcorder.The obtained flowpatterns reveal that there is no noticeable difference between928P.Hanafizadeh et al./Scientia Iranica,Transactions B:Mechanical Engineering 18(2011)923–929Figure 11:Comparison between the achieved flow patterns with the work of Ide et al.[30]for a pipe with diameter of 2mm.Figure 12:Proposed two-phase vertical upward flow pattern map.two-phase,upward flow patterns in this range of diameters.A new flow pattern map was achieved for vertical mini pipes,due to a comparison of the flow patterns of these three diameters of pipe.The proposed map was compared with existing research.A comparison of the present work and previous research shows that the flow patterns of slug,messy slug and semi-annular in the present work are compatible with the intermittent flow pattern of Ide et al.[30].However,in the present study,the annular flow is seen at a lower superficial air velocity than that in the work of Ide et al.[30].AcknowledgmentsThis research was funded by Iran Supplying Petrochemical Industries,Parts,Equipment and Chemical Design Corporation (SPEC),as a joint research project with Sharif University of Technology (project No.KPR-8628077).References[1]Suo,M.and Griffith,P.‘‘Two-phase flow in capillary tubes’’,Int.J.Basic Eng.,86,pp.576–582(1964).[2]Sadatomi,Y.,Sato,Y.and Saruwatari,S.‘‘Two-phase flow in verticalnoncircular channels’’,Int.J.Multiphase Flow ,8,pp.641–655(1982).[3]Xu,J.L.,Cheng,P.and Zhao,T.S.‘‘Gas–liquid two-phase flow regimes inrectangular channels with mini/micro gaps’’,Int.J.Multiphase Flow ,25,pp.411–432(1999).[4]Hetsroni,G.,Mosyak, A.,Segal,Z.and Pogrebnyak, E.‘‘Two-phaseflow patterns in parallel micro-channels’’,Int.J.Multiphase Flow ,29,pp.341–360(2003).[5]Fugakata,K.,Kasagi,N.,Ua-arayaporn,P.and Himeno,T.‘‘Numericalsimulation of gas liquid two-phase flow and convective heat transfer in a micro tube’’,Int.J.Heat and Fluid Flow ,28,pp.72–82(2007).[6]He,Q.and Kasagi,N.‘‘Numerical investigation on flow pattern andpressure drop characteristics of slug flow in a micro tube’’,6th Int.ASME Conf.on Nanochannels,Microchannels and Minichannels ,Darmstadt,Germany,pp.24–35(2008).[7]Carlson,A.,Kudinov,P.and Narayanan,C.‘‘Prediction of two-phase flowin small tubes:a systematic comparison of state-of-the-art CMFD codes’’,5th Europe Thermal-Sci.Conf.,The Netherlands,pp.138–150(2008).[8]Saisorn,S.and Wongwises,S.‘‘An experimental investigation of two-phaseair–water flow through a horizontal circular micro-channel’’,Exp.Thermal Fluid Sci.,33,pp.306–315(2009).[9]Yao,S.C.and Chang,Y.‘‘Pool boiling heat transfer in a confined space’’,Int.J.Heat Mass Transf.,26,pp.841–848(1983).[10]Damianides,D.A.and Westwater,J.W.‘‘Two-phase flow patterns in acompact heat exchanger and in small tubes’’,2nd UK National Conf.on Heat Transf.,11,United Kingdom,London,pp.1257–1268(1988).[11]Mertz,R.,Wein,A.and Groll,C.‘‘Experimental investigation of flow boilingheat transfer in narrow channels’’,Calore e Technologia ,14(2),pp.47–54(1996).[12]Kasza,K.E.,Didascalou,T.and Wambsganss,M.W.‘‘Microscale flow visu-alization of nucleate boiling in small channels:mechanisms influencing heat transfer’’,Int.Conf.on Compact Heat Exchanges for the Process Indus-tries ,New York,USA,pp.343–352(1997).[13]Lin,S.,Kew,P.A.and Cornwell,K.‘‘Two-phase flow regimes and heattransfer in small tubes and channels’’,11th Int.Heat Transf.Conf.,Kyongju,Korea,2,pp.45–50(1998).[14]Barnea,D.,Luninsky,Y.and Taitel,Y.‘‘Flow pattern in horizontal andvertical two-phase flow in small diameter pipes’’,Canadian J.Chem.Eng.,61,pp.617–620(1983).[15]Sheng, C.H.and Palm, B.‘‘The visualization of boiling in small-diameter tubes’’,Int.Conf.on Heat Transport and Transport Phenomena in Microsystems ,Banff,Canada,pp.44–53(2001).[16]Cornwell,K.and Kew,P.A.‘‘Boiling in small parallel channels’’,CEC Conf.on Energy Eff.in Process Tech.,Athens,Greece,pp.624–638(1992).[17]Ory, E.,Yuan,H.,Prosperetti, A.,Popinet,S.and Zaleski,S.‘‘Growthand collapse of a vapor bubble in a narrow tube’’,Phys.Fluids ,12,pp.1268–1277(2000).[18]Ghiaasiaan,S.M.and Abdel-Khalik,S.I.‘‘Two-phase flow in micro-channels’’,Adv.Heat Transf.,34,pp.145–253(2001).[19]Jiang,L.,Wong,M.and Zohar,Y.‘‘Forced convection boiling in a micro-channel heat sink’’,Int.J.Micro-Electro-Mech.Sys.,10,pp.80–87(2000).[20]Chedester,R.C.and Ghiaasiaan,S.M.‘‘A proposed mechanism for hydrodynamically-controlled onset of significant void in microtubes’’,Int.J.Heat Fluid Flow ,23,pp.769–775(2002).[21]Kandlikar,S.G.‘‘Fundamental issues related to flow boiling in minichan-nels and microchannels’’,Exp.Therm.Fluid Sci.,26,pp.389–407(2002).[22]Lee,J.and Mudawar,I.‘‘Two phase flow in high heat flux micro channelheat sink for refrigeration cooling applications’’,Int.J.Heat Mass Transf.,48,pp.928–955(2005).[23]Serizawa,A.‘‘Gas liquid two-phase flow in microchannels’’,In MultiphaseFlow Handbook ,C.T.Crowe,Ed.,2nd ed.,pp.830–887,CRC Press (2006).[24]Thome,J.R.,Dupont,V.and Jacobi, A.M.‘‘Heat transfer model forevaporation in micro channels’’,Int.J.Heat Mass Transf.,47,pp.3375–3385(2004).P.Hanafizadeh et al./Scientia Iranica,Transactions B:Mechanical Engineering18(2011)923–929929[25]Revellin,R.and Thome,J.R.‘‘Experimental investigation of R-134a andR-245fa two-phase flow in microchannels for different flow conditions’’, Int.J.Heat Fluid Flow,28,pp.63–71(2007).[26]Sobierska, E.,Kulenovic,R.and Mertz,R.‘‘Heat transfer mechanismand flow pattern during flow boiling of water in a vertical narrow channel experimental results’’,Int.J.Thermal Sci.,46,pp.1172–1181 (2007).[27]Shi,L.‘‘Fuzzy recognition for gas–liquid two-phase flow pattern based onimage processing’’,Proc.of13rd IEEE Int.Conf.on Control and Automation, pp.1424–1427(2007).[28]Heijmans,H.J.A.M.,Morphological Image Operators,Academic Press,NewYork(1994).[29]/help/toolbox/images/index.html.[30]Ide,H.,Kariyasaki,A.and Fukano,T.‘‘Fundamental data on the gas–liquidtwo-phase flow in minichannels’’,Int.J.Thermal Sci.,46,pp.519–530 (2007).Pedram Hanafizadeh received his M.S.and Ph.D.Degrees in Mechanical Engineering from the Centre of Excellence in Energy Conversion at Sharif University of Technology,Tehran,Iran,in2005and2010,respectively.His work is mainly concentrated on the field of Multiphase Flow,Experimentally, Numerically and Analytically.His research interests include Characteristics of Multiphase Flow,Heat Transfer,Boiling and Condensation,Instrumentation in Fluid Flow,Image Processing for Flow Field Analysis,and Industrial and Applicable Usage of Multiphase Flow.Mohammad Hassan Saidi is Professor and Chairman of the School of Mechanical Engineering at Sharif University of Technology,Tehran,Iran. His current research interests include Multiphase Flows,Heat Transfer Enhancement in Boiling and Condensation,Modelling of Pulse Refrigeration, Vortex Tube Refrigerator,Indoor Air Quality and Clean Room Technology, Energy Efficiency in Home Appliances and Desiccant Cooling Systems.Arash Nouri Gheimasi obtained his B.S.Degree in Mechanical Engineering in2010,and is currently an M.S.student at the Centre of Excellence in Energy Conversion at the School of Mechanical Engineering,Sharif University of Technology,Tehran,Iran,under the supervision of Professor Saidi.His B.S. thesis involved work on the Characteristics of Gas-Liquid Two-Phase Flow in Mini Pipes and he is now working on Application of Visual Techniques in Two-Phase Flow.His research interests include the area of Two Phase Flow and Its Industrial Applications.Soheil Ghanbarzade received his B.S.and M.S.Degrees in Mechanical Engineering from the Centre of Excellence in Energy Conversion at Sharif University of Technology in2008and2010,respectively.Since then he has worked under the supervision of Professor M.H.Saidi as research staff in the Multiphase Group.His research interests include:Analytical,Numerical and Experimental Methods to Study Characteristics of Large Scale and Mini Scale Air-Water,Two-Phase Flows.He holds a Gold medal from the13th National Olympiad of Mechanical Engineering in Iran,and is currently a Ph.D.student of Petroleum Engineering at the University of Texas,Austin,USA.。

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ICH协调指导原则分析方法验证Q2ICH共识指导原则目录1引言 (1)2范围 (2)3分析方法验证研究 (2)3.1分析方法生命周期中的验证 (4)3.2可报告范围 (5)3.3稳定性指示特性的证明 (6)3.4多变量分析方法的考虑 (6)3.4.1参比分析方法 (6)4验证试验、方法学和评价 (7)4.1专属性/选择性 (7)4.1.1无干扰 (7)4.1.2正交方法比较 (7)4.1.3技术固有合理性 (7)4.1.4数据要求 (8)4.1.4.1鉴别 (8)4.1.4.2含量测定、纯度和杂质检查 (8)4.2工作范围 (9)4.2.1响应 (9)4.2.1.1线性响应 (9)4.2.1.2非线性响应 (10)4.2.1.3多变量校正 (10)4.2.2范围下限验证 (10)4.2.2.1根据信噪比 (10)4.2.2.2根据线性响应值的标准偏差和标准曲线斜率 (11)4.2.2.3根据范围下限的准确度和精密度 (12)i4.2.2.4数据要求 (12)4.3准确度和精密度 (12)4.3.1准确度 (12)4.3.1.1参比物比较 (13)4.3.1.2加标研究 (13)4.3.1.3正交方法比较 (13)4.3.1.4数据要求 (13)4.3.2精密度 (14)4.3.2.1重复性 (14)4.3.2.2中间精密度 (14)4.3.2.3重现性 (14)4.3.2.4数据要求 (14)4.3.3准确度和精密度的合并评价方式 (15)4.3.3.1数据要求 (15)4.4耐用性 (15)5术语 (16)6参考文献 (24)7附件1验证试验选择 (24)8附件2分析技术例证 (25)ii1引言12本指导原则是讨论药物在ICH成员监管机构注册申请时，递交的分析方法验证所3需考虑的要素。

J. Chem. Chem. Eng. 5 (2011) 246-249Effect of Alkali-NaOH Solution on the Nature of Synthesized Zeolite from 2:1 Tunisian Clays: XRD and MAS-NMR InvestigationMahdi Meftah1, Walid Oueslati1, 2 and Abdesslem Ben Haj Amara11. Laboratoire de Physique des Matériaux Lamellaires et Nanomatériaux Hybrides, UR05/13-01 (PMLNMH) Faculté des Sciences de Bizerte, 7021 Zarzouna, Tunisia2. Faculté des Sciences de Gafsa, Département de Physique, Campus Universiatire Sidi Ahmed Zarrouk, 2112 Gafsa, Tunisia Received: October 12, 2010 / Accepted: November 17, 2010 / Published: March 30, 2011.Abstract: This work focuses the effect of alkali-NaOH solution on the nature of synthesized zeolite from 2:1 Tunisian clays. This study was achieved using correlation between results obtained from X-ray diffraction (XRD) and MAS-NMR analysis. Preliminary treatment was adopted to prepare the starting sample that is placed in contact with NaOH solution at variable concentration. A specific hydrothermal reactor, allowing the control of pH > 9, temperature and a continuous stirring of the sample in the NaOH solution, was used to achieve these syntheses. The obtained results showed that, for concentration value ≈1N, the final complex presented characteristic XRD and MAS-NMR line of zeolite P. For 3N solution concentration we obtained zeolite HS. All synthesize process are controlled by XRD and MAS-NMR investigation.Key words: Alkali-NaOH solution, hydrothermal reactor, zeolite P, HS.1. IntroductionZeolites are crystalline aluminosilicates with a 3-dimensional and open anion framework consisting of oxygen-sharing TO4 tetrahedral, where T is Si or Al. Their framework contains interconnected voids which can be occupied with adsorbed molecules or cations. The general empirical formula is M x/n Al x Si(2-x)O4·mH2O where n is the valence of the exchangeable cation M, m water content and 0 ≤ x ≤ 1. The flexibility of the zeolite Si-O-Si bond explains the fact that more than 200 structures have been determined. The synthesized process of zeolite from natural clay minerals (i.e. 1:1 and 2:1 clay) was studied by several authors [1, 2]. In 1948, the first confirmation of zeolite synthesis had been traced by Barrer who reported the synthesis of the modernite [3].Corresponding author:Mahdi Meftah, Ph.D., research fields: materiel sciences, zeolite synthesize, spectroscopic methods, condensed matter. E-mail:********************.At the same time Milton and Back succeeded in synthesizing other zeolite, using lower temperature (≈100 ℃) and higher alkalinity [4]. Later, great successful progress is recorded by discovering one of the most commercially zeolite type Linde A (LTA) [5]. After that, the applied zeolite field was integrated in all industry aspect with the use of zeolite A: (1) to substitute the phosphate in detergent. Later zeolite P and X, AX (80% A, 20% X) were also introduced into the marked for detergent [6, 7], (2) in catalysis, ion exchange, molecular sieves, photochemistry and solar energy conversion [8]. In other way, zeolite type HS was synthesized using well and poorly ordered kaolinites and metakaolinites [9]. Indeed, the experimental protocol adopted on zeolite synthesis process does not be considered like novelty but some experimental parameters as the starting material, the particle size and the preparation mode influence the resulting material andcrystallisation rate. The main objective of this workAll Rights Reserved.Effect of Alkali-NaOH Solution on the Nature of Synthesized Zeolite from 2:1 Tunisian Clays: XRD andMAS-NMR Investigation247consists of characterizing zeolite synthesis process from 2:1 Tunisian clay and demonstrating the effect of alkali-NaOH concentration on the final obtained product.2. Materials and Methods2.1 Starting MaterialsThe starting materials are originated from the region Bir El Hfay (southern Tunisia). It is an irregular interstratified illite-smectite. The < 2 µm fraction was prepared according to the classic protocol of extraction which was developed by Tessier et al. [10]. The obtained structural formula per half unit cell is: (Si 4.00)(Al 1.10, Fe 0.50, Mg 0.40)O10(OH)2(M+ 0.4) with M+ is a monovalent cation. Preliminary treatment consisted of preparing an amorphous phase by heating the host mineral. This process is assured by heating ~50 g of solid at T > 800 ℃ [11].2.2 Experimental ProtocolA total of 100 mL of a given NaOH solution was heated to 100 ℃ in 250 mL reactor provided with a refrigerant system. A total of 10 g of clay was introduced. Reaction was maintained with magnetic stirring for periods of time ranging from 2 to 24 h. The final mixture was centrifuged to 10,000 rpm. The solid phase was washed several times with distilled water until pH 9.5-10, dialyzed with distilled water and dried at 80 ℃.2.3 Characterizing Method2.3.1 XRD AnalysisPowder X-ray diffraction patterns were obtained by a BRUKER D8 Advance diffractometer using Cu-Kαradiation and the 2θ range between 5-50° and operating at 40 KV and 30 mA. The determination of the lattice parameters from the XRD patterns requires identification of the peak positions, which can normally be achieved using a peak-search process, provided that all systematic errors have been eliminated by careful measurements of the zero-point detector position. The pattern indexing was performed using the indexing software TOPAS.2.3.2 MAS-NMR AnalysisThe Magic Angle Spinning Nuclear Magnetic Resonance (MAS-NMR) spectra were recorded on a BRUKER-300 MHz Ulrashield spectrometer. Experiments were performed using a 7.1 T magnetic field intensity corresponding to resonance frequencies 78.22 MHz and 59.62 MHz respectively for the core 27Al and 29Si. Impulse period has been optimized for each signal and does not exceed some μs. The numberof accumulation is higher than 500 in the case of the core 29Si (4.6% of abundance) and about 200 for the core 27Al (100% of abundance) for the two cores (27Al and 29Si).3. Results and Discussion3.1 XRD InvestigationWe reported in Fig. 1 that the XRD spectra of the solids obtained after reaction of clay with 1N NaOH solutions during different periods of time (i.e. 2 h, 4 h and 24 h). We noted that little change is observed for reaction times (Fig. 1) of 2 and 4 h. After 24 h, new peaks appeared, the most intense ones were situated at 12.44, 17.67, 21.62, 27.97 and 33.30° 2θ (Cu-Kα). They correspond to the P-zeolite as it was described by Ref. [2]. After a reaction time of 24 h the diffraction peaks of clay became very weak.Fig. 1 Experimental XRD patterns of heated illite-smectite and 1N NaOH treated at T = 100 ℃ during (a) 2 h; (b) 4 h; (c) 24 h, phases of zeolite P.All Rights Reserved.Effect of Alkali-NaOH Solution on the Nature of Synthesized Zeolite from 2:1 Tunisian Clays: XRD andMAS-NMR Investigation248When 3N NaOH solutions were used, changesappeared after a reaction time of 4 hours (Fig. 2). A newphase appeared having the following XRD peaks, 14,24.3, 27.99, 33.28 and 34.65° 2θ (Cu-Kα), according toRefs. [12, 13], this corresponds to the HS zeolite. Fromthe comparison of the patterns reported in Fig. 2, wenoted that after 24 h of reaction, it is clear that the peaksintensity related to the HS phase increase. This is in linewith the increasing amount of the zeolite phase.3.2 MAS-NMR AnalysisAccording to the NMR study of zeolite [14], the 29Sisignal of the sample obtained from treated startingmateriel with 1N NaOH solution. Fig. 3a presents achemical shifts observed at 79.82, 86.52, 91.36, and102.97 ppm with a low intensity corresponding tozeolite P. After 24 h of alkaline treatment, the 27AlMAS-RMN spectrum in Fig. 3b shows a line ofresonance at 58.21 ppm which can be attributed totetrahedral aluminium.The 29Si MAS-NMR and 27Al MAS-NMR spectra ofHS zeolite obtained by 3N NaOH solution treatmentare reported respectively in Figs. 4a and 4b. After 24 htreatment, we obtained five lines of chemical shiftlocated at -107.35, -106.92, -97.28, -91.87, -87.25 ppmfor 29Si and -58.32 ppm for 27Al. These shifts arerelated to zeolite HS [14, 15].Fig. 2 Experimental XRD patterns of heated illite-smectite and 1.5N NaOH treated at T = 100 ℃ during (a) 2 h; (b) 4 h;(c) 24 h, phases of zeolite HS. Fig. 3 (a) 29Si MAS-NMR spectrum of zeolite P obtained from heated illite-smectites. (b) 27Al MAS-NMR spectrum of zeolite P obtained from heated illite-smectites.These results demonstrate that the concentration of alkaline NaOH solution affect the final product nature (i.e synthesized zeolite). Indeed, zeolite can be synthesized using respectively low and high concentration value of NaOH solution.The characteristics and structural parameters for all synthesized phases are summarised in Table 1.4. ConclusionsIn this work we demonstrate that zeolite P is the main crystalline products obtained when heated interstratified illite-smectite is used as a starting materials with a low value of NaOH concentration.(a)(b)All Rights Reserved.Effect of Alkali-NaOH Solution on the Nature of Synthesized Zeolite from 2:1 Tunisian Clays: XRD andMAS-NMR Investigation249Fig. 4 (a) 29Si MAS-NMR spectrum of zeolite HS obtainedfrom heated illite-smectites. (b) 27Al MAS-NMR spectrumof zeolite HS obtained from heated illite-smectites.Table 1 Characteristics and structural parameters for allsynthesized phases.Sample heated illite-smectite T > 800 ℃NaOH solution 1.5N 3NTemp (℃) 100 100Time reaction (h) 24 24XRD analysis zeolite P zeolite HSComposition of material Na6(H2O)12[Si10Al6O32]Na6(H2O)8|[Si6Al6O24]Cell parameters a = b = c = 10.043 Åα = β = γ = 90°a =b =c = 8.848 Åα = β = γ = 90°NMR spectroscopy Si/Al ratio ≈1= 1Whereas zeolite HS is obtained by increasing the amount of NaOH solution.AcknowledgmentsThe manuscript was much improved by the constructive reviews of two anonymous reviewers. The editorial assistance of the editorial staff of the Journal of Chemistry and Chemical Engineering is acknowledged.References[1]M. Murat, A. Amokrane, J.P. Bastide, L. Montanaro,Synthesis of zeolites from thermally activated kaolinite,Some observations on nucleation and growth, Clay Miner.27 (1992) 119-130.[2] D.W. Breck, Zeolite Molecular Sieves: Structure,Chemistry and Uses, Wiley, New York, 1974.[3]R.M. Barrer, Syntheses and reactions of mordenite, J.Chem. Soc. 23(1948) 2158- 2163.[4]R.M. Milton, U.S. Patent 2 882 244, 1959.[5] A. Carlos, R. Ríos, D.W. Craig, M.C. Oscar, Synthesis ofzeolite LTA from thermally treated kaolinite, Rev. Fac. Ing.Univ. Antioquia 53 (2010) 30-41.[6]R.C. Adams, L. Xu, K. Moller, T. Bein, W.N. Delgass,Zeolite encapsulated vanadium oxo species for the catalyticreduction of NO by NH3, Catalysis and Photocatalysis onMetal Oxides 33 (1-3) (1997) 263-278.[7]H.G. Hautal, Laundry, Detergent Zeolites in anEcobalance Spotligt-Sepawa, Tagung Bad Diirkheim, 1996.[8] A. Corma, C. Corell, J. Perez-Pariente, Synthesis andcharacterization of the MCM-22 zeolite, Zeolites 15 (1995)2-8.[9] D.S. Coombs, T. Whetten, Geological society of americacomposition of 4-analcime from sedimentary and burialmetamorphic rocks, GSA Bulletin 78 (2) (1967) 269-282.[10]H.B. Rhaim, D. Tessier, A.B.H. Amara, Mineralogy of the< 2 µm fraction of three mixed-layer clays from southernand central Tunisia, Clay Mineral 35 (2) (2000) 375-381.[11]M. Meftah, W. Oueslati, A.B.H. Amara, Synthesis processof zeolite P using a poorly crystallized kaolinite, PhysicsProcedia (2009) 1081-1086.[12]R.M. Barrer, E.A.D. White, The hydrothermal chemistryof silicates, part I: Synthesis lithium aluminosilicates, J.Chem. Soc. (1951) 1267.[13]I. Hassan, H.D. Grundy, The crystal structures ofsodalite-group minerals, Acta Cryst. B 40 (1984) 6-13. [14] A. Madani, A. Aznar, J. Sanz, J.M. Serratosa, 29Si and27Al NMR study of zeolite formation from alkali-leachedkaolinites: Influence of thermal preactivation, J. Phys.Chem. 94 (1990) 760-765.[15]N. Benharrats, M. Belbachir, A.P. Legrand, J.B.D’Espinose de la Caillerie, 29Si and 27Al MAS NMR studyof the zeolitization of kaolin by alkali leaching, ClayMiner. 38 (2003) 49-61.(a)(b) All Rights Reserved.。

全文分为作者个人简介和正文两个部分：作者个人简介：Hello everyone, I am an author dedicated to creating and sharing high-quality document templates. In this era of information overload, accurate and efficient communication has become especially important. I firmly believe that good communication can build bridges between people, playing an indispensable role in academia, career, and daily life. Therefore, I decided to invest my knowledge and skills into creating valuable documents to help people find inspiration and direction when needed.正文：探究物体在斜面上的运动实验英语作文全文共3篇示例，供读者参考篇1An Experimental Investigation into the Motion of Objects on an Inclined PlaneIntroductionIn our physics class, we were tasked with conducting an experiment to explore the motion of objects on an inclined plane. This concept is not only fascinating from a scientific standpoint but also has numerous real-world applications, from understanding the dynamics of vehicles on slopes to designing efficient ramps and conveyor belts. As a student passionate about understanding the natural world, I was excited to delve into this hands-on learning experience.Theoretical BackgroundBefore diving into the experiment, it was essential to understand the theoretical principles underpinning the motion of objects on an inclined plane. According to Newton's laws of motion, when an object is placed on an inclined surface, it experiences two primary forces: the force of gravity acting vertically downward, and the normal force exerted by the surface perpendicular to the plane.The component of the gravitational force acting parallel to the inclined surface is responsible for causing the object's acceleration down the plane. This component, known as the parallel force, is proportional to the sine of the angle of inclination (θ) m ultiplied by the object's mass (m) and theacceleration due to gravity (g). The equation governing this relationship is:Parallel Force = m × g × sin(θ)Additionally, the acceleration of the object down the inclined plane is independent of its mass and solely depends on the angle of inclination and the acceleration due to gravity. This acceleration can be calculated using the following equation:Acceleration = g × sin(θ)These fundamental principles provided the theoretical foundation for our experiment, allowing us to formulate hypotheses and design an appropriate methodology.Experimental SetupTo conduct the experiment, we assembled the following materials:A sturdy wooden plankVarious objects of different masses (e.g., wooden blocks, metal cylinders)A protractor to measure the angle of inclinationA stopwatch or timerMeter sticks or measuring tapesNotebook and pen for recording observationsThe experimental setup involved positioning the wooden plank on a flat surface and adjusting its angle of inclination using books or blocks as supports. We measured the angle using the protractor and ensured that the surface was smooth and free from obstructions.ProcedureWe started by setting the plank at a specific angle, let's say 30 degrees.One team member held the object at the top of the inclined plane, while another prepared to time its descent using the stopwatch.Upon releasing the object, we recorded the time it took to travel a predetermined distance along the inclined plane.We repeated this process multiple times for the same object and angle, calculating the average time and velocity.Next, we varied the angle of inclination, keeping the same object, and repeated the timing measurements.Finally, we swapped objects of different masses and repeated the entire process for each new object.Data Collection and AnalysisThroughout the experiment, we meticulously recorded our observations, including the angle of inclination, object mass, distance traveled, and time taken for each trial. We then computed the average velocities and accelerations for each combination of angle and mass.To analyze the data, we plotted graphs of velocity versus time and acceleration versus the sine of the angle of inclination. These visual representations allowed us to identify patterns and evaluate the validity of the theoretical equations.Results and DiscussionOur experimental results largely aligned with the theoretical predictions. We observed that the acceleration of an object down the inclined plane was indeed independent of its mass, as predicted by the equation Acceleration = g × sin(θ). The grap hs of acceleration versus sine of the angle followed a linear trend, further confirming this relationship.Moreover, we noted that objects with larger masses experienced greater parallel forces, as expected from theequation Parallel Force = m × g × sin(θ). However, their accelerations remained constant for a given angle, aligning with the theoretical principles.Interestingly, we encountered some minor discrepancies between our experimental data and the theoretical values, which could be attributed to factors such as air resistance, friction, and measurement uncertainties. These deviations highlighted the importance of controlling experimental conditions and accounting for potential sources of error.ConclusionThrough this hands-on experiment, we gained valuable insights into the motion of objects on an inclined plane. We observed firsthand the relationships between acceleration, mass, and the angle of inclination, solidifying our understanding of the theoretical concepts.The experimental process also taught us essential skills in data collection, analysis, and critical thinking. We learned to design controlled experiments, record precise measurements, and interpret results in the context of scientific theories.Moving forward, we can apply the knowledge gained from this experiment to various real-world scenarios, such asanalyzing the motion of vehicles on slopes, optimizing the design of ramps and conveyor belts, or even understanding the dynamics of certain sports and recreational activities.Overall, this experimental investigation into the motion of objects on an inclined plane was an enriching and rewarding experience. It not only deepened our comprehension of physics principles but also cultivated our scientific curiosity and problem-solving abilities, preparing us for future scientific endeavors.篇2Investigating the Motion of Objects on an Inclined PlaneIt was just another typical day in physics class when Mr. Davis announced we would be doing a hands-on experiment to explore the motion of objects on inclined planes. I have to admit, I wasn't exactly thrilled at first. Physics experiments can sometimes be tedious and dull. However, as Mr. Davis explained what we'd be doing, I became more intrigued and even a little excited.The core idea was straightforward enough – we'd be rolling objects down ramps set at different angles and measuring their speeds and acceleration. But Mr. Davis hinted there would besome twists that would make it more engaging than just watching things roll down slopes. He divided us into groups of four, and each group received a plastic ramp, a stopwatch, a meterstick, some masking tape, and two objects – a hollow plastic cylinder and a solid aluminum cylinder of the same size.Once we had our materials, Mr. Davis went over the procedure. First, we would use the masking tape to make evenly spaced lines every 20 cm along the ramp to mark intervals. Then, for each angle we tested, we'd release the hollow cylinder from rest at the top and use the stopwatch to measure its time over each 20 cm interval to determine its speed at different points. We'd repeat this three times and average the results.The first angle seemed fairly tame – just 10 degrees from horizontal. I figured the cylinder would trickle down slowly in that case. But I was in for a surprise! Even at that modest angle, the cylinder quickly built up pretty good speed about halfway down the ramp. Clearly, the old saying "objects in motion tend to stay in motion" wasn't kidding around.After recording temps for the 10 degree trials, we had to tilt the ramp to 20 degrees and repeat. This time, I could definitely notice some serious acceleration happening as the cylinder rolled along. Mr. Davis then went around and checked our data,offering suggestions on techniques like when to start and stop the stopwatch.Once we had successfully timed the hollow cylinder, the real fun began. We switched over to the solid aluminum cylinder of the same diameter and mass. In theory, it should have accelerated at the same rate, assuming we neglected air resistance. However, pretty much every group noticed clear disparities between the hollow and solid cylinders.No matter how carefully we performed the timings, the solid cylinder consistently traveled slower than its hollow counterpart. At first, I figured we must be doing something wrong with our methods. But Mr. Davis assured us this discrepancy was exactly what he expected to see emerge. He then launched into an explanation about rotational inertia and how objects need to expend energy to set spinning motions in addition to linear motions.With the aluminum cylinder's mass concentrated toward its outer edges, it experienced greater resistance to rotation compared to the hollow cylinder. Thus, more of the cylinder's kinetic energy went into overcoming rotational inertia rather than just linear motion, resulting in slower overall speeds. Mind officially blown!Mr. Davis then had us ramp things up further by tilting the ramp to 30 degrees to accentuate the acceleration. Sure enough, the speed disparities between the solid and hollow cylinders became even more pronounced. As we timing technicians sweated through running trials, I realized this experiment had transformed into an engaging exploration of some pretty profound physics concepts.After completing all the ramp angles, Mr. Davis had us process our data into velocity vs time graphs. Seeing the curved lines vividly depict the accelerated motion helped solidify the concepts in a visual way. We analyzed our graphs and used the velocity and position data to calculate the accelerations of the cylinders down the ramps.While Newton's second law specifies that acceleration should depend only on mass and force, not shape or distribution, our numbers confirmed that rotational inertia created real disparities between the hollow and solid cylinders. The temperature was rising in that physics room as our brains worked to connect the experiments to the core concepts!For the finale, Mr. Davis had us investigate how changing the mass affected the acceleration by adding weights to the hollow cylinder. As expected, increasing the mass did reduce theacceleration compared to the unweighted trials, beautifully confirming the force to mass ratio relationship.What started as a seemingly simple experiment turned into an engrossing journey hitting on key topics like kinematics, Newton's laws, energy, rotational dynamics, and data visualization. My eyes were opened to how deceivingly simple setups can provide profound insights when you start plugging in the physics. I'll never look at a hollow cylinder the same way again!As I walked out of class, surprisingly energized instead of drained like after many labs, I felt grateful for a professor committed to creating engaging hands-on experiences. Too often, physics can get bogged down in dry equations disconnected from reality. But Dr. Davis's inclined plane experiment brilliantly revealed how the world actually works through a deceptively simple scenario.I don't know if I'll become a physicist, but I gained an appreciation for the mindset of uncovering truths about nature through well-designed experiments and modeling. Looking back, I'm really glad I didn't just dismiss this as "another lame physics lab." Sometimes the most valuable lessons come from unexpected places if you're willing to lean in with an open mind.Now if you'll excuse me, I need to go roll myself down a few inclined planes to verify some newly sparked inquiries!篇3Investigating the Motion of Objects on an Inclined PlaneAs a high school physics student, one of the most intriguing experiments we conducted was exploring the motion of objects on an inclined plane. This hands-on activity allowed us to witness firsthand the principles of mechanics and gain a deeper understanding of the interplay between forces, acceleration, and motion.The setup was deceptively simple: a long, smooth ramp propped at various angles, a selection of objects with different masses and materials, and a set of timers and rulers to measure distances and durations. However, behind this straightforward apparatus lay a world of fascinating observations and revelations waiting to be uncovered.Our first task was to release a small wooden block from the top of the ramp and observe its behavior. At a shallow angle, the block sluggishly crept down the incline, its motion seemingly defying the laws of gravity. As we increased the angle, the block's descent accelerated, gathering speed with each passing second.This stark contrast piqued our curiosity, prompting us to delve deeper into the underlying principles governing this phenomenon.Through our teacher's guidance and supplementary readings, we learned about the intricate interplay between the forces acting on the block. The weight of the object, represented by its mass and the acceleration due to gravity, pulled it downward. Simultaneously, the normal force exerted by the ramp surface counteracted this downward pull, resolving into components parallel and perpendicular to the incline.The parallel component of the normal force, commonly referred to as the "force of friction," opposed the block's motion, acting as a resistive force. Conversely, the component of the weight force parallel to the ramp provided the driving force, propelling the block forward. As we increased the angle, the driving force grew stronger relative to the frictional force, resulting in the observed acceleration.Armed with this newfound knowledge, we eagerly dove into our next set of experiments. We systematically varied the ramp's angle, meticulously measuring the block's displacement over fixed time intervals. By plotting these data points on graphs, weunveiled the remarkable relationship between the angle of incline and the acceleration of the object.Our findings corroborated the theoretical predictions: the acceleration increased proportionally with the sine of the angle, a direct consequence of the geometric resolution of forces. This validation of mathematical models through empirical evidence filled us with a profound sense of awe and appreciation for the predictive power of physics.Undeterred by our initial success, we pushed our investigation further by introducing objects of varying masses and materials. We observed that while the acceleration remained consistent for objects of the same mass and material, it varied across different compositions. Heavier objects experienced slower accelerations due to the increased frictional forces, while lighter ones zipped down the ramp with greater ease.The concept of friction took on a new dimension when we experimented with different surface materials on the ramp. Rough surfaces, such as sandpaper, significantly impeded the motion, while smoother surfaces facilitated faster accelerations. This revelatory insight highlighted the crucial role of surface properties in determining frictional forces and their impact on motion.As we progressed through our experiments, we encountered instances where our results deviated from theoretical predictions. Rather than being discouraged, these discrepancies fueled our curiosity and sparked lively discussions within our group. We hypothesized potential sources of error, such as imperfections in the ramp surface, air resistance, or measurement inaccuracies, and devised strategies to minimize their impact.One particularly thought-provoking observation emerged when we attempted to release the block from different heights along the ramp. Contrary to our initial expectations, the acceleration remained unaffected by the starting position, as long as the angle of incline remained constant. This counterintuitive finding challenged our intuitive notions and prompted us to reevaluate our understanding of the principles governing motion on inclined planes.Throughout our investigations, we encountered moments of triumph and frustration, successes and setbacks. However, each experience served as a invaluable learning opportunity, sharpening our critical thinking skills, fostering teamwork, and instilling in us a deep appreciation for the scientific method.As we concluded our experiments, we couldn't help but reflect on the broader implications of our findings. The principlesgoverning motion on inclined planes extend far beyond the confines of our classroom, manifesting in diverse natural phenomena and engineering applications. From the design of roller coasters and ski slopes to the construction of ramps and conveyor belts, a thorough understanding of these principles is crucial for optimizing efficiency and ensuring safety.Moreover, our investigation highlighted the importance of empirical observation and experimentation in validating theoretical models. While mathematical equations and simulations provide invaluable insights, their true power lies in their ability to accurately describe and predict real-world phenomena. By bridging the gap between theory and practice, we gained a deeper appreciation for the iterative nature of scientific inquiry and the continuous quest for knowledge.As I look back on this transformative experience, I am filled with a sense of gratitude for the opportunity to engage in hands-on learning and exploratory investigations. The lessons learned transcended the confines of physics, instilling in me a passion for lifelong learning, a commitment to intellectual curiosity, and a profound respect for the elegance and complexity of the natural world.。

美国FDA《联邦规章典集》（CFR）第21篇目录中文版发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：美国《联邦规章典集》（Code of Federal Regulations，CFR）第21篇“食品与药品”（Title 21―Food and Drugs）共有9卷（Volume）、3章（Chapter）、1499部（Parts）。

其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（Food and Drug Administration，Department of Health and Human Services）的规章；第9卷第2章第1300―1399部，为司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）的规章；第9卷第3章第1400―1499部，为毒品控制政策办公室（Office of National Drug Control Policy）的规章。

第21篇“食品与药品”（Tit le 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）1 Ⅰ1-99 健康与人类服务部食品与药品管理局（FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）2 100-1693 170-1994 200-2995 300-4996 500-5997 600-7998 800-12999 Ⅱ1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）Ⅲ1400-1499 毒品控制政策办公室（Office of National Drug Control Policy）第21篇“食品与药品”（Title 21―Food and Drugs）的章、部目录部(Part) 中译文原英文第Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINIST RATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）第A分章―总则（SUBCHAPTER A―GENERAL）1 一般强制执行规章GENERAL ENFORCEMENT REGULATIONS2 一般行政规则与决定GENERAL ADMINISTRATIVE RULINGS AND DECISIONS3 产品管辖权PRODUCT JURISDICTION5 组织ORGANIZATION7 强制执行政策ENFORCEMENT POLICY10 行政规范与程序ADMINISTRATIVE PRACTICES AND PROCEDURES11 电子化记录；电子化签名ELECTRONIC RECORDS; ELECTRONIC SIGNATURES12 正式证据的公众听证FORMAL EVIDENTIARY PUBLIC HEARING13 在公众质询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY14 在公众咨询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE15 在FDA局长前的公众听证PUBLIC HEARING BEFORE THE COMMISSIONER16 在FDA前的规制性听证REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION17 行政罚款听证CIVIL MONEY PENALTIES HEARINGS19 行为标准与利益冲突STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST20 公共信息PUBLIC INFORMATION21 隐私保护PROTECTION OF PRIVACY25 环境影响考虑ENVIRONMENTAL IMPACT CONSIDERATIONS26 药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY50 人类受试者的保护PROTECTION OF HUMAN SUBJECTS54 临床试验者的财务公开FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS56 机构审查委员会INSTITUTIONAL REVIEW BOARDS58 对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES60 专利期恢复PATENT TERM RESTORATION70 色素添加剂COLOR ADDITIVES71 色素添加剂申请COLOR ADDITIVE PETITIONS73 免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION74 适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION80 色素添加剂认证COLOR ADDITIVE CERTIFICATION81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS82 经认证的临时性列表的色素和规范的列表LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS83-98 [预留的] [Reserved]99 已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES第B分章―用于人类消费的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）100 总则GENERAL101 食品标识FOOD LABELING102 非标准化食品的普通的或者通常的名称COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS104 食品的营养质量指南NUTRITIONAL QUALITY GUIDELINES FOR FOODS105 特殊膳食用途的食品FOODS FOR SPECIAL DIETARY USE106 婴儿配方母乳替代食品质量控制程序INFANT FORMULA QUALITY CONTROL PROCEDURES107 婴儿配方母乳替代食品INFANT FORMULA108 紧急许可控制EMERGENCY PERMIT CONTROL109 在人类食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL110 在制造、包装或者保存人类食品中的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD113 装在密封容器中的热加工低酸食品THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS114 酸化食品ACIDIFIED FOODS115 带壳蛋SHELL EGGS119 存在显著或者不合理风险的膳食补充剂DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK120 危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS123 鱼与渔业产品FISH AND FISHERY PRODUCTS129 饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER130 食品标准：总则FOOD STANDARDS: GENERAL131 乳与奶油MILK AND CREAM133 乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS135 冷冻点心FROZEN DESSERTS136 烘焙产品BAKERY PRODUCTS137 谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS139 通心粉与面条产品MACARONI AND NOODLE PRODUCTS145 罐装水果CANNED FRUITS146 罐装水果汁CANNED FRUIT JUICES150 水果黄油、果冻、防腐剂以及相关产品FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS152 水果馅饼FRUIT PIES155 罐装蔬菜CANNED VEGETABLES156 蔬菜汁VEGETABLE JUICES158 冷冻蔬菜FROZEN VEGETABLES160 蛋与蛋制品EGGS AND EGG PRODUCTS161 鱼与有壳的水生动物FISH AND SHELLFISH163 可可制品CACAO PRODUCTS164 树坚果与花生制品TREE NUT AND PEANUT PRODUCTS165 饮料BEVERAGES166 人造黄油MARGARINE168 增甜剂与餐桌糖浆SWEETENERS AND TABLE SIRUPS169 食品敷料与调味料FOOD DRESSINGS AND FLAVORINGS170 食品添加剂FOOD ADDITIVES171 食品添加剂申请FOOD ADDITIVE PETITIONS172 允许直接加入用于人类消费食品的食品添加剂FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION173 在用于人类消费的食品中允许的次直接的食品添加剂SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION174 间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL175 间接食品添加剂：胶粘剂与涂层的组分INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS176 间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS177 间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: POLYMERS178 间接食品添加剂：辅剂、生产助剂和消毒剂INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS 179 在食品生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY181 先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS182 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE184 被确认为一般认为安全的直接食品物质DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 186 被确认为一般认为安全的间接食品物质INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 189 禁止用于人类食品的物质SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD190 膳食补充剂DIETARY SUPPLEMENTS191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）200 总则GENERAL201 标识LABELING202 处方药广告PRESCRIPTION DRUG ADVERTISING203 处方药销售PRESCRIPTION DRUG MARKETING205 对批发处方药销售商颁发州执照的指南GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS206 人用固体口服剂型药品的印码IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE207 药品生产者的登记与商业销售的药品的列表REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION208 处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS210 制造、加工、包装或者保存药品的现行良好制造规范；总则CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL211 对完成的药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS216 药房配药PHARMACY COMPOUNDING225 对含药饲料的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS226 对A型含药物品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES 250 对特殊人用药品的特殊要求SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS290 管制的药品CONTROLLED DRUGS299 药品；正式名称与已确定的名称DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES第D分章―人用药品（SUBCHAPTER D―DRUGS FOR HUMAN USE）300 总则GENERAL310 新药NEW DRUGS312 试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS316 罕见病药ORPHAN DRUGS320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS328 含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL330 一般认为安全与有效以及不错误标识的非处方人用药品OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED331 用于非处方的人类使用的抗酸产品ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE332 用于非处方的人类使用的抗胃肠气胀产品ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE333 用于非处方的人类使用的局部抗菌药品TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE335 用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE336 用于非处方的人类使用的止吐药品ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE338 用于非处方的人类使用的帮助夜间睡眠的药品NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE340 用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE341 用于非处方的人类使用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE343 用于非处方的人类使用的内服的止痛、退热以及抗风湿药品INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE344 用于非处方的人类使用的局部的耳部药品TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE346 用于非处方的人类使用的肛肠药品ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE347 用于非处方的人类使用的皮肤保护药品SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE349 用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE350 用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE352 用于非处方的人类使用的遮光药品SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]355 用于非处方的人类使用的防龋药品ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE357 用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE358 用于非处方的人类使用的其他外用药品MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE361 一般认为安全与有效以及不错误标识的处方人用药品：用于研究的药品PRESCRIPTION DRUGS FOR HUMAN USE GENERALLYRECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH369 在用于非处方销售的药品与器械上关于警告的解释性声明INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE370-499 [预留的] [Reserved]第E分章―动物药品、饮料和相关产品（SUB CHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）500 总则GENERAL501 动物食品标识ANIMAL FOOD LABELING502 非标准化的动物食品的普通的或通常的名称COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS509 在动物食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL510 新动物药NEW ANIMAL DRUGS511 作为试验用途的新动物药NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE514 新动物药申请NEW ANIMAL DRUG APPLICATIONS515 含药饲料厂执照MEDICATED FEED MILL LICENSE520 口服剂型的新动物药ORAL DOSAGE FORM NEW ANIMAL DRUGS522 植入或者注射剂型的新动物药IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS524 眼科和局部剂型的新动物药OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS526 乳房内的剂型INTRAMAMMARY DOSAGE FORMS529 某些其他剂型的新动物药CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS530 在动物中的特别标签药品使用EXTRALABEL DRUG USE IN ANIMALS556 在食品中新动物药残留的容许量TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD558 用于动物饲料的新动物药NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS564 [预留的] [Reserved]570 食品添加剂FOOD ADDITIVES571 食品添加剂申请FOOD ADDITIVE PETITIONS573 在动物饲料与饮用水中允许的食品添加剂FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS579 在动物饲料和宠物食品的生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD582 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE584 在动物饲料与饮用水中被确认为一般认为安全的食品物质FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS589 禁止用于动物食品或者饲料的物质SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED590-599 [预留的] [Reserved]第F分章―生物制品（SUB CHAPTER F―BIOLOGICS）600 生物制品：总则BIOLOGICAL PRODUCTS: GENERAL601 颁发执照LICENSING606 对血液与血液组分的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS610 普通生物制品标准GENERAL BIOLOGICAL PRODUCTS STANDARDS630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES640 对人类血液和血液制品的附加标准ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS660 对用于实验室检测的诊断物质的附加标准ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS680 对其他产品的附加标准ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS第G分章―化妆品（SUBCHAPTER G―COSMETICS）700 总则GENERAL701 化妆品标识COSMETIC LABELING710 化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS720 化妆品配料构成声明的自愿存档VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS740 化妆品警告声明COSMETIC PRODUCT WARNING STATEMENTS741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）800 总则GENERAL801 标识LABELING803 医疗器械报告MEDICAL DEVICE REPORTING806 医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS807 对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES808 对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS809 人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE810 医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY812 试验用器械豁免INVESTIGATIONAL DEVICE EXEMPTIONS813 [预留的] [Reserved]814 医疗器械的上市前批准PREMARKET APPROVAL OF MEDICAL DEVICES820 质量体系规章QUALITY SYSTEM REGULATION821 医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS822 上市后监视POSTMARKET SURVEILLANCE860 医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURES861 性能标准制定程序PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT862 临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES864 血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES866 免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES868 麻醉学器械ANESTHESIOLOGY DEVICES870 心血管器械CARDIOVASCULAR DEVICES872 牙科器械DENTAL DEVICES874 耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES876 胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES878 普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES880 普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES882 神经学器械NEUROLOGICAL DEVICES884 产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES886 眼科器械OPHTHALMIC DEVICES888 矫形外科器械ORTHOPEDIC DEVICES890 内科学器械PHYSICAL MEDICINE DEVICES892 放射学器械RADIOLOGY DEVICES895 禁止的器械BANNED DEVICES898 电极铅线与患者电缆的性能标准PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDA RDS ACT）900 乳房造影法MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）1000 总则GENERAL1002 记录与报告RECORDS AND REPORTS1003 缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY1004 电子产品的回购、修理或者置换REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS1005 电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS1010 电子产品的性能标准：总则PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL1020 电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS1030 微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS1040 发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS1050 声波、次声波和超声波发生产品的性能标准PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS第K分章―[预留的]（SUBCHAPTER K―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）1210 根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT1240 传染病的控制CONTROL OF COMMUNICABLE DISEASES1250 州际运输卫生INTERSTATE CONVEYANCE SANITATION1251-1269 [预留的] [Reserved]1270 预期用于移植的人体组织HUMAN TISSUE INTENDED FOR TRANSPLANTATION1271 人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299 [预留的] [Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）1300 定义DEFINITIONS1301 管制物质的制造者、分销者和调剂者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES1303 定额QUOTAS1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS1305 令的格式ORDER FORMS1306 处方PRESCRIPTIONS1307 杂项MISCELLANEOUS1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS1310 列入表的化学品和某些机器的记录与报告RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved]1312 管制物质的进口与出口IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES1313 前体与必要化学品的进口与出口IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS1314-1315 [预留的] [Reserved]1316 行政职能、规范和程序ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）1400 [预留的] [Reserved]1401 信息的公众可及性PUBLIC AVAILABILITY OF INFORMATION1402 强制性解密审查MANDATORY DECLASSIFICATION REVIEW1403 对给予州和地方政府资金和合作协议的统一行政要求UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS1404 政府范围的排除与暂停（非获得）GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)1405 对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)1406-1499 [预留的] [Reserved]。

FDA临床试验常见词汇中译文对照Aaction letter 决定通知active comparator 活性药物对照组active control = AC 阳性对照，活性对照active ingredient 有效成分Active Substance Master File (ASMF) 欧洲药物主文件acute myocardial infarction 急性心肌梗死acute tibial fractures 急性胫骨骨折adalimumab (Humira) 阿达木单抗adaptive design 自适应设计adaptive randomization 自适应随机ADE = adverse drug event 药物不良事件Adenoviral Vectors 腺病毒载体adequate and well-controlled studies 充分严格的对照研究ADHD = Attention-deficit hyperactivity disorder注意力缺陷多动障碍; 注意力不足过动症; 多动症adhesion barrier product 防黏著产品adjuvant 助剂; 佐剂auxiliary;adjuvant therapy 佐药疗法，辅助疗法ADL = activities of daily living 日常生活活动能力ADME = absorption, distribution, metabolism, and excretion(药物)吸收、分配、代谢和排除ADR = adverse drug reaction 药物不良反应adrenal cortex 肾上腺皮质adrenal cortical hormone 肾上腺皮质激素adrenal gland 肾上腺adrenaline 肾上腺素adulterated devices 掺假器械adverse drug reaction = ADR药物不良反应adverse effect 副作用adverse event = AE 不良事件adverse medical events 不良医学事件adverse reaction (adverse event) 药物不良反应advisory 提醒advocacy and support groups 倡导和支持团体AE = adverse event 不良事件AERS = Adverse Event Reporting System 不良事件报告系统BBIMO Bioresearch Monitoring Program 生物研究监测bioavailability (F) 生物利用度biochemical drugs 生化药品biocides 生物杀灭剂; 杀生物剂biocompatibility 生物相容性biodegradable 生物分解bio-engineered, transgenic food 转基因食物bioequivalence; bioequivalent 生物等效应biofilm 细菌薄膜, 生物膜biologic 生物制品biological response modifiers BRM 生物应答调节剂biological therapeutic agents 生物治疗药剂biomarker 生物标志物biometrics 生物统计; 生物识别技术bion stimulator 生物体刺激器bionic knee 仿生膝关节biopharma: biopharmaceutical products 生物药物产品bipolar 双相燥郁症birth defect 出生缺陷, 新生儿缺陷, 先天缺陷BLA = biologic license application 生物制品许可申请blank control 空白对照blend uniformity analysis 混合均匀度分析blind 盲法blind codes 编制盲底blind review 盲态审核blinding method 盲法blinding/ masking 盲法，设盲blister packaging 泡罩包装; 水泡眼block 分段;层block size 每段的长度blocked randomization 区组随机Ccase history 病历case record form = CRF病例报告表/病例记录表case report form 病例报告表cash curve 现金曲线cash trap 现金陷阱; 现金套牢categorical variable 分类变量CLIA Clinical Laboratory Improvement Amendments临床实验室改进修订案clinical (human) data 临床数据clinical endpoint临床终点clinical equivalence 临床等效应clinical hold 临床试验暂停通知clinical investigator 临床研究者Clinical Pharmacists 临床药师Clinical Research Coordinator = CRC临床研究协调者clinical study 临床研究Clinical Study Application = CSA临床研究申请clinical study report 临床试验的总结报告clinical trial 临床试验clinical trial application = CTA 临床试验申请clinical trial exemption = CTX 临床试验免责clinical trial protocol = CTP 临床试验方案Clinical Trial Report = CTR临床试验报告clinically significant results 有临床意义cohort 队列cohort studies 队列研究co-investigator = CI合作研究者comparison 对照Compassionate Use 体恤使用competitive labeling 优越标签Complementary And Alternative Therapy 补充性和非传统治疗Complete response 完全有效compliance 遵守；对遵守法规情况的监管composite variable 复合变量Compression Test 压缩试验computer-assisted trial design= CATD计算机辅助试验设计Con Meds = concomitant medications 联合用药confidence interval 可信区间confidence level 置信水平Confidentiality Regarding Trial Participants 为试验参与者保密control对照control group 对照组controlled clinical trials 临床对照实验Controlled Trials 对照试验Critical Path 关键路径CRM = continual reassessment method 连续重新评估方法crossover design 交叉设计cross-over study 交叉研究crossover therapy 交叉治疗CRF = case report form 病例报告表dosage form 剂型dosage regimen 给药方案dose-ranging study 剂量范围研究dose-reaction relation 剂量－反应关系dose-related adverse reactions 剂量相关的不良反应double blinding 双盲double dummy 双模拟double dummy 双模拟double dummy technique 双盲双模拟技术double-blind study 双盲研究Double-Masked Study 双盲研究DRGs = Diagnosis Related Group System 疾病诊断相关分组drop out 脱落drop test 落震试验;跌落试验drug eluting coronary stents 药物洗脱支架drug product 药物产品drug substance 原料药drug-drug interaction56 药物-药物相互作用drug-food interaction 药物-食物的相互作用EEPS = Electronic Entry Processing System 电子录入处理系统effectiveness 疗效efficacy 有效性测定efficacy (Of a drug or treatment) 药效；药品疗效EEMEA = European Medical Evaluation Agency; European Agency for the Evaluation of Medicinal Products; European Medicines Agency 药物评价机构; 欧洲医药品管理局emergency envelope 应急信件Empiric Bayesian Multiple Gamma-Poisson Shrinker经验性贝氏法（伽玛泊松分布缩检法）empirical 经验性endpoint 终点endpoint criteria 终点指标factorial design 析因设计factorial trial 析因试验failure 无效，失败Fair Packaging and Labeling Act (1966) 公平包装和标签法False Claims Act 防制不实请求法false therapeutic claims 错误的疗效声明full analysis set 全分析集full factorial design 全因子试验法Iinclusion criteria 入选标准inclusion/exclusion criteria 入选/排除标准incremental exposure 食品中递增摄入量incubation period/latency period 潜伏期IND = Investigational New Drug 临床研究新药INDA = investigational new drug application NDA前申报阶段indemnity insurance 赔偿保险Independent Data Monitoring = IDM独立数据监察Independent Data Monitoring Committee = IDMC独立数据监察委员会independent ethics committee = IEC 独立伦理委员会indications 适应症investigational new drug = IND 临床研究新药investigational product 试验药物investigator 调研人员investigator's brochure = IB 研究者手册Mmasked 设盲mean absorption time = MAT(药物在体内的)平均吸收时间mean disintegration time = MDIT(药物在体内的)平均崩解时间Mean Dissolution Time = MDT (药物在体内的)平均释放时间Mean Residence Time = MRT(药物在体内的)平均滞留时间medical governance 医药治理Medicare 老年医疗保险制度；联邦老年医保medication guides (for patients) 用药指南Medicines Control Agency = MCA英国药品监督局Misbranding 错误标签; 冒牌Miscoding 编码错误missing value 缺失值mixed effect model 混合效应模式MLD = minimal lethal dose 最小致死剂量MoA = Mechanism of Action 作用机制;作用机理monitor 监查员monitoring plan监查计划monitoring report 监查报告MR = moderate response 好转MRA = Agreement on Mutual Recognition 相互承认协定MTD = maximal tolerance dose 最大耐受剂量multicenter trial 多中心试验multi-drug resistance 多药物抗药性multiple arm trials 多治疗组的试验mutual recognition procedure (EU) 相互承认程序OOS = Overall survival 总生存率Pparallel group design 平行组设计parameter estimation 参数估计parametric release 参数放行parametric statistics 参数统计方法patient file 病人档案patient global; pt global 病人总体评价patient history 病历per protocol ( PP) analysis 符合方案分析PFS = progression-free survival 无疾病进展存活率PGE = patient global evaluation 病人总体评价PHA = preliminary hazards analysis 预先危险分析pharmaceutical equivalence 药剂等效性pharmaceutics药剂学pharmacodynamics=PD 药物效应动力学; 简称药效学pharmacoepidemiology 药物流行病学pharmacokinetics = PK 药代动力学; 简称药动学pharmacology 药理学Pharmacovigilance105 药物警戒pharmacy 配药学PharMetrics claims database 索赔数据库PhRMA = Pharmaceutical Research and Manufacturers of America美国药物研究与生产商协会PIC=Pharmaceutical Inspection Convention 药品检查协定PIC/S Pharmaceutical Inspection Cooperation Scheme 药物检查合作计划pipeline assets 开发中产品PK = pharmacokinetics 药物代谢动力学; 药动学，药代动力学placebo 安慰剂placebo control 安慰剂对照placebo controlled study 安慰剂对照研究placebo effect 安慰剂效应PMA = premarket approval 上市前许可; 销售前批准PMCs = post marketing commitments 承诺药品上市后的继续研究PMDRA = Post Marketing Drug Risk Assessment 上市后药品风险评估(办公室) PMHx = Past Medical History 既往病史PMN = Premarket Notification 销售前通知PMS = Premenstrual syndrome 经前综合症POC (Proof-of-concept) Clinical Trials 概念证明POC = point-of-care testing 床旁分析polytomies 多分类pooled analysis = PA 荟萃分析postmarket surveillance 上市后监督post-marketing surveillance; postmarket safety surveillance 销售（上市）后监督power 把握度; 检验效能Pp = Process Performance 工序绩效Ppk = Process Performance Index 工序绩效指数precautions 慎用；注意事项precision 精密度preclinical (animal) data 临床前(动物实验)数据preclinical study 临床前研究predicate device = legally marketed device that is not subject to Premarket Approval (PMA)和已合法在市场上销售的且不需要做PMA“销售前批准”的Pre-market Approval (Application) = PMA上市前许可（申请）premarket notification 上市前通知pre-marketing surveillance 销售（上市）前监督preparing and submitting 起草和申报prescription drug 处方药preservation 保藏prevalence 患病率prevention trials预防试验primary (coronary) event 原位病变primary endpoint 主要终点primary mode of action = PMOA 首要作用模式primary variable 主要变量principal investigator = PI主要研究者Principles of Qualification 确认（验证）原则process controls 工艺控制process validation 工艺验证product codes 产品的号码product differentiation 产品差异化，产品特色化product license = PL 产品许可证product life cycle (PLC) 产品生命周期prognosis 预后progression-free survival = PFS 无进展生存progressive Disease PD 病情进展proof of principle study 原理循证研究propensity score 倾向性评分protocol 试验方案; 方案protocol amendment 方案补正prototype design 原型设计protozoa 原生动物门proven acceptable Range = PAR 确定可接受范围PTC = Product Technical Complaints 药品技术投诉Qqualification system for licensed pharmacist 执业药师资格准入制度qualified health claims 有保留的健康宣称Qualified Person = QP 受权人quality assurance = QA质量保证quality assurance unit = QAU质量保证部门quality control = QC 质量控制quality management systems 质量管理体系quality of life trials or supportive care trials 生存质量试验quality risk management = QRM 质量风险管理quantitative risk assessment 量化风险评估Rrandomization 随机化randomized trial 随机化试验randomized, double blinded clinical trial 随机双盲对照研究range check 范围检查rating scale 量表RCT = randomized clinical trials 随机临床试验RCT = randomized controlled trial 随机对照试验RDE: remote data entry 远距数据输入ready-to-eat foods 即食食品reagents 试剂recall 召回; 强制回收RECIST = Response Evaluation Criteria in Solid Tumors 实体瘤的疗效评价标准reconditioning 整改; 货物重整理；货物重包装recycled plastics 可循环利用塑料制品reference product 参比制剂reference samples 标准样品regulatory methodology 质量管理方法regulatory methods validation 管理用分析方法的验证（FDA对NDA提供的方法进行验证）regulatory specification 质量管理规格标准（NDA提供）rejection 排异remote monitoring system 远程监测系统; 远程监控REMS = Risk Evaluation and Mitigation Strategies 风险评估和减缓战略risk 受害risk assessment (risk analysis + risk evaluation) 风险评估，论证risk classification 风险分类;Risk Communications Advisory Committee 风险交流咨询委员会risk evaluation (part of risk assessment) 风险评价risk/ benefit analysis 风险-获益分析risk-benefit ratio 效益/风险比route of administration 给药途径royalties 专利使用费RPN = Risk Priority Number 风险优先指数RR = Response rate 缓解率RSD = (intra-day and inter-day) relative standard deviations (日内和日间) 相对标准差Ssafety advisory 安全建议safety evaluation 安全性评价safety evaluators 安全性评估人员safety set 安全性评价的数据集screening trials 筛选性试验SD = standard deviation 标准(偏)差SE = substantial equivalence 实质上的等同Seal Strength Test 密封强度试验sequence 试验次序SFDA 129= State Food And Drug Administration 国家食品药品监督管理局SG & A= Sales, General and Administration 销售、管理和一般费用shaft 传动轴SHEA = Society for Healthcare Epidemiology of America 美国医院流行病学学会sheaths 护套shelf life 保存期限; 保质期SIC codes = Standard Industrial Classification codes 标准产业分类代码side effects 副作用significance level 显著性水平Significant Risk (SR) 显著的危险性simple randomization 简单随机simulation model 仿真模型single blinding单盲single-blind study 单盲研究single-masked study 单盲研究site assessment = SA现场评估site audit 试验机构稽查SMDA = Safe Medical Devices Act of 1990 1990年安全医疗器械法SMF = Site Master File 生产场所主文件sNDA = supplemental NDA 疗效补充新药上市申请sponsor-investigator = SI 申办研究者spontaneous reports; voluntary reports 药品不良反应自愿报告SPS = Agreement on the Application Of Sanitary and Phytosanitary Measures卫生与植物卫生措施实施协议;简称SPS协议SSI = surgical site infection 手术部位感染SSOPs = Sanitation Standard Operating Procedures 卫生标准操作程序standard curve 标准曲线standard deviation 标准偏差standard drug 标准药物standard operating procedure = SOP 标准操作规程standard treatment 标准治疗Standards Of Care131 医护标准State Food and Drug Administration = SFDA国家食品药品监督管理局statistic 统计量statistical analysis plan = SAP 统计分析计划statistical model 统计模型statistical significance 统计学意义statistical tables 统计分析表Statisticians in the Pharmaceutical Industry = PSI制药业统计学家协会steady-state Area Under the Curve = AUCss稳态药时曲线下面积/稳态血药浓度－时间曲线下面积stratified 分层study audit 研究稽查study endpoint 研究终点Study Personnel List = SPL研究人员名单study site研究中心study type 研究类型subchronic toxicity studies 亚慢性毒性研究subgroup 亚组sub-investigator 助理研究者subject 受试者subject diary = SD 受试者日记subject enrollment 受试者入选subject enrollment log = SEL受试者入选表Subject Identification Code List = SIC受试者识别代码表subject recruitment 受试者招募subject screening log = SSL受试者筛选表submission 申报；递交subspecialties, internal medicine 亚专科,内科substantial equivalence to legally marketed (predicate) device 和已合法在市场上销售的且不需要做PMA“销售前批准”的相似产品有实质上的等同Ttrain-the-trainer program 培训者培训计划treatment group 试验组treatment IND 治疗性试验性新药申请treatment trials 治疗性试验trial error 试验误差trial initial meeting 试验启动会议trial master file 试验总档案trial objective 试验目的trial site 试验场所TRICARE 军队医疗系统triple blinding 三盲two one-side test 双单侧检验UAE = unexpected adverse event 预料外不良事件unblinding 破盲;揭盲under reporting bias 少报偏差unexplained syncope 不明原因晕厥unresectable 不能手术切除variability 变异variable 变量WHO International Collaborating Center for Drug Monitoring(世界卫生组织)国际药物监测合作中心WHO International Conference of Drug Regulatory Authorities= WHO-ICDRAWHO国际药品管理当局会议WHO Programme for International Drug Monitoring = PIDMWHO 国际药物监测合作计划。

Experimental investigation and numerical simulation for weakening the thermal fluctuations in aT-junctionK.Gao a ,P.Wang b ,T.Lu a ,⇑,T.Song caCollege of Mechanical and Electrical Engineering,Beijing University of Chemical Technology,Beijing 100029,China bSchool of Energy and Power Engineering,Dalian University of Technology,Dalian 116024,China cChina Nuclear Power Technology Research Institute Co.,Ltd,Shenzhen 518124,Chinaa r t i c l e i n f o Article history:Received 25August 2014Received in revised form 17November 2014Accepted 4January 2015Available online 17January 2015Keywords:Experimental investigation Numerical simulation Tee junctionThermal fluctuationa b s t r a c tIn this work,the mixing processes of hot and cold fluids with and without a distributor are predicted by experiments and numerical simulations using large-eddy simulation (LES)on FLUENT platform.Temperatures at different positions of the internal wall and mixing conditions caused by T-junctions at different times are obtained,then the simulated normalized mean and root-mean square (RMS)temperature,velocity vector and temperature contour for the two structures,namely with and without a distributor,are compared.The results show that,compared with the a T-junction without a distributor,the mixing region of hot and cold water in the T-junction with distributor moves to the middle of the pipe,and the inclusion of the distributor reduces the temperature fluctuations of internal wall noticeably and makes the mixing of hot and cold water more efficient.Ó2015Elsevier Ltd.All rights reserved.1.IntroductionTee junction is a familiar structure that is universally used in pipeline systems of power plants,nuclear power plants and chemi-cal plants,it is often applied to mix hot and cold fluid of main and branch pipes.The fluctuations of fluid temperature are transported to the solid walls by heat convection and conduction.This can cause cyclical thermal stresses and subsequent thermal fatigue cracking of the piping (Lee et al.,2009).So far,leakage accidents took place in several light water and sodium cooled reactors due to thermal fati-gue.In 1998,a crack was discovered at a mixing tee in which cold water from a branch pipe flowed into the main pipe in the residual heat removal (RHR)system in a reactor in Civaux,France.Metallur-gical studies concluded that the crack was caused by a high degree of cycle thermal fatigue (Eric Blondet,2002).In 1990,sodium leak-age happened in the French reactor Superphenix (Ricard and Sperandio,1996).It has been established that mixing hot and cold sodium can induce temperature fluctuations and result in thermal fatigue (IAEA,2002).Therefore,it is significant to study how to weaken thermal fatigue of the piping wall to ensure the integrity and safety of the piping system in a nuclear power plant.In the analysis of thermal fatigue,temperature fluctuation is a very important evaluation parameter.A reliable lifetime assess-ment of these components is difficult because usually only thenominal temperature differences between the hot and cold fluids are known,whereas the instantaneous temperatures and heat fluxes at the surface are unknown (Paffumi et al.,2013).Kamaya and Nakamura (2011)used the transient temperature obtained by simulation to assess the distribution of thermal stress and fati-gue when cold fluid flowed into the main pipe from a branch pipe.Numerical simulation of flow in the tee has been carried out Simoneau et al.(2010)to get temperature and its fluctuation curves,and the numerical results were in good agreement with the experimental data.Through the analysis on thermal fatigue stress,it draw the conclusion that the enhanced heat transfer coef-ficient and the temperature difference between hot and cold fluids were primary factors of thermal fatigue failure of tees.Many numerical simulations and experiments have been carried out to evaluate the flow and heat transfer in a mixing tee junction (Metzner and Wilke,2005;Hu and Kazimi,2006;Hosseini et al.,2008;Durve et al.,2010;Frank et al.,2010;Jayaraju et al.,2010;Galpin and Simoneau,2011;Aulery et al.,2012;Cao et al.,2012).Turbulent models such as Reynolds-averaged Navier–Stokes (RANS),Unsteady Reynolds averaged Navier Stokes (URANS),Scale-Adaptive Simulation (SAS),Reynolds stress model (RSM),detached eddy simulations (DES),and LES have all been used in industrial applications.As one of the choices of turbulent model for predicting the mixing flow in tee junctions,the RSM can bemused to describe the momentum conservation of the mixing (Durve et al.,2010;Frank et al.,2010).Turbulent mixing phenomena in a T-junction have been numerically investigated using the k $x/10.1016/j.anucene.2015.01.0010306-4549/Ó2015Elsevier Ltd.All rights reserved.Corresponding author.based baseline Reynolds stress model(BSL RSM)(Frank et al.,2010) for two different cases.Durve et al.(2010)applied the RSM to pre-dict the velocityfield of three non-isothermal parallel jetsflowing in an experiment setup used to simulate theflow occurring at the core outlet region of a fast breeder reactor(FBR),with a Reynolds number of1.5Â104.Theflow in tube of different Reynolds numbers (Re)andflow velocity ratio were studied experimentally with three-dimensional scanning using particle image velocimetry(3D-SPIV) (Brücker,1997).Large-eddy simulation(LES)is an alternative turbulence model with different subgridscale models often employed to predict velocity and temperaturefluctuations.Indeed many numerical studies have shown the capability of LES to model thermalfluctu-ations in turbulent mixing.LES was performed(Lee et al.,2009)to analyze temperaturefluctuation in the tee junction and the simu-lated results were in good agreement with the experimental data. Thermal striping phenomena in the tee junction had been numer-ically investigated using LES(Hu and Kazimi,2006)for two differ-ent mixing cases,and the simulated normalized mean and root-mean square(RMS)was consistent with experimental results. LES in a mixing tee were carried out(Galpin and Simoneau, 2011)in order to evaluate the sensitivity of numerical results to the subgrid scale model by comparing the experimental results, and to investigate the possibility of reducing thefluid computa-tional domain at the inlet.Another simulation that mixing of a hot and a coldfluid stream in a vertical tee junction with an upstream elbow main pipe was carried out with LES(Lu et al., 2013).And the numerical results show that the normalized RMS temperature and velocity decrease with the increases of the elbow curvature ratio and dimensionless distance.In the meantime,many scholars have studied how to weaken the thermalfluctuation.Experiments and simulation were con-ducted(Wu et al.,2003)on a tee junction geometry with a sleeve tube in it.Theflow is divided into three types of jets by theflow velocity ratio in main and branch pipes.Through the analysis of flowfield and velocityfield of various jets types,it indicate that the addition of sleeve tube relieve the thermal shock caused by the coldfluid injection rge-eddy simulation have been used(Lu et al.,2010)to evaluate the thermal striping phe-nomena in tee junctions with periodic porous media,the temper-ature and velocityfield inside the tubes are obtained.The research revealed that the addition of a porous reduces the tem-perature and velocityfluctuations in the mixing tube.As mentioned above,experiments and numerical simulations for both tee junction geometry with a sleeve tube in it(Wu et al., 2003)and for a mixing tee with periodic porous media in it(Lu et al.,2010)have been carried out.The results of previous researches provide a good reference value for this work that anal-yses the role of distributor in weakening the thermalfluctuation of internal piping wall,and this structure has not been studied to date,to the best of our knowledge.In this work,mixing processes have been studied by the experiment and numerically predicted with LES.Then the simulated normalized mean and root-mean square(RMS)temperature,velocity vector and temperature con-tour of the two tees are compared.2.Experiment systemThe Experimentflowchart is presented in Fig.1.The experimen-tal system consists of four main components,a cold water supply line,a hot water supply line,a test section,and a data acquisition unit.The experiment device is shown in Fig.2.Experimentfluid was adjusted to the desired temperature by the heater and chiller, and then was pumped to the test section.After mixing thefluid is returned to the heater for recycling,some of the excessfluid is dis-charged through the overflow pipe.During the mixing of thefluids, the temperature of the mixingfluid is collected and recorded by the thermocouple probe installed on the tube wall.The experiment requires two different structures of the test sec-tion,Fig.3is the T-junction section without the branch liquid dis-tributor and Fig.4is that with the branch liquid distributor.The addition of this structure has two main functions:(1)changing the mixing position of hot and coldfluids:moving the mixing zone to the middle of the tube,and away from the main pipe wall;(2) increasing the intensity of mixing process:adding the fence near the outlet of distributor enhanced the mixed disturbance and the exacerbatedfluid mixing of the inner tube.For the convenience of observing and adjusting the mixing process,the test section is a round pipe made of plexiglass,and other pipes are made of steel. Fig.5is the physical model of the branch liquid distributor.The test conditions in the present experiment are shown in Table1.We collected the instantaneous temperature data of every measurement points by the data collector.The distribution of sam-pling points are shown in Fig.6,there are total eight thermocou-ples in the circumferential direction at each plane.In the T-junction section without the branch liquid distributor,the number of the collected plane is6(x/d m=1,2,3,4,6,8).That is to say there are48thermocouples in the structure without distributor.And in the T-junction section with the branch liquid distributor,the num-ber of the collected plane is5(x/d m=2,3,4,6,8),which means there are40thermocouples in the structure that with the distrib-utor.In both structures,the distance between measuring point the thermocouple probe and the inner wall is30mm.Since the collect-ing frequency of the collector is limited,we use1Hz as the collect-ing frequency after theflowfield is stable,and the total number of collection is800s.Table1shows the specific parameters of the test conditions.NomenclatureT time(s)Pr Prandtl numberLs mixing length of subgrid grid(m)T temperature(K)G acceleration of gravity(m/s2)K von Karman numberCs Smagorinsky numberS ij subgrid strain rate tensorM R momentum ratio of main pipe and branch pipe TÃnormalized mean temperaturesTÃrms normalized RMS temperaturesR d diameter ratioR v velocity ratiox,y,z axial coordinate(m)Greek symbolsqfluid density(kg/m3)b coefficient of thermal expansionl viscosity(Pa s)ltturbulent viscosity(Pa s)k thermal conductivity(w/(m k))C P heat capacity(J/(kg°C))K.Gao et al./Annals of Nuclear Energy78(2015)180–187181182K.Gao et al./Annals of Nuclear Energy78(2015)180–1871\4\11-thermometers 2\5\10-pressure gauge 3\9-flow meter 6-c ooler 7-heater8-overflow 12-test sec tion 13-thermoc ouple data c ollec torFig.1.Experimentflow chart.Fig.5.Physical model of the branch liquid distributor(a)the whole graph(b)theprofile map.Fig.2.Experiment device of thermalfluctuation.Fig.3.Schematic diagram of the T-junction section without the branch liquid distributor.Fig.4.Schematic diagram of the T-junction section with the branch liquid distributor.3.Numerical simulationFig.7is the numerical model based on the experimental section of T junction.The size of the model,boundary conditions are con-sistent with the experiment.In which,hot water enters from the left of main pipe,and cold water enters from the branch pipe,finally the mixingfluidflow out of the right of the main pipe.Dur-ing the calculation,the steady results offlowfield and heat transfer are obtained by Reynolds stress model(RSM)firstly,and then set @q@tþ@q u i@x i¼0ð1Þ@q u i@tþ@q u i u j@x j¼À@ p@x iÀq0bðTÀT0Þgþ@@x jlþltÀÁ@ u i@x jþ@ u j@x i!ð2Þ@q T@tþ@q Tu j@x j¼@@x jkc p@T@x jÀq T00u00j!ð3ÞIn these equations,q,b,l,l t,k and c p represent the density,ther-mal expansion coefficient,molecular viscosity,turbulent viscosity, thermal conductivity and specific heat capacity,respectively.The Smagorinsky–Lilly model is used for the turbulent viscosity,which is described as:lt¼q L2s j S jð4Þj S jTable1Experimental conditions.Main pipe Branch pipeFlow rate (m3/h)Temperature(K)Flow rate(m3/h)Temperature(K)Without distributor0.645304.650.270287.65With distributor0.645304.650.266287.65Fig.6.The distribution of sampling points on the planes.Physical model of T-junction(a)without the branch liquid distributor;(b)with the branch liquid distributor.K.Gao et al./Annals of Nuclear Energy78(2015)180–187183ij ¼12@ u i@x jþ@ u j@x ið7Þwhere k is the Von Karman constant of0.42;d is the distance to the closest wall;C s is the Smagorinsky constant of0.1;V is the volume of the computational cell.4.Results and discussionThe normalized mean and root-mean square temperature are used to describe the time-averaged temperature and temperature fluctuation intensity.The normalized temperature is defined as:ü1NX Ni¼1TÃið8ÞN is the total number of sample times.TÃi¼T iÀT cT hÀT cð9Þwhere T i is the transient temperature,T c is the coldfluid inlet tem-perature and T h is hotfluid inlet temperature.The root-mean square(RMS)of the normalized temperature is defined as:TÃrms¼ffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi1X Ni¼1TÃiÀTÃ2rð10Þ184K.Gao et al./Annals of Nuclear Energy78(2015)180–187parison of experimental and numerical resultsAs can be seen from the Fig.8,the numerical normalized mean temperature distributions at the plane x/d m=1and the plane x/ d m=2are in good qualitative agreement and in adequate quantita-tive agreement,and most of them are within the experimental deviation of±20%.Meanwhile,the lifting trends of the data are the same.In the direction of180°,the mean temperatures are both minimal.And with the angle decrease to0°,the temperatures are gradually increased.Quantitative differences between the experi-ment and numerical results are that the normalized mean temper-atures given by LES are larger than the experimental data.That is because we did not add insulation unit on tube wall in the exper-iment,leading the transfer of some heat into the air.And in the process of numerical simulation,we ignored the convective heat transfer between the wall and the air.As shown in Fig.9,although the numerical results and experi-mental results have a little difference at the plane x/dm=2around the location of225°and the plane x/dm=2around the location of 0°and315°,all of them are within the error range that can be accepted.Both the simulations and experimental results give a lar-ger mean temperature in the top half of the main pipe than in the bottom half.This verifies the validity of the LES model for predict-ing the mixing of hot and coldfluids in a tee junction.The normalized RMS temperature on the plane x/d m=1and plane x/d m=2are shown in Fig.10,respectively.Similar to the nor-malized mean temperature,the normalized RMS temperature lines agree very well with the experiment ones.Both of the maximum values appear at the bottom half of the pipe.This indicates that the maximum temperaturefluctuations of main pipe appear on the opposite of the branch pipe inlet in this condition.As shown in Fig.11,the numerical results and the experimental results have the same trend and the numerical data are agreed well with the experimental ones.By comparison with Figs.4and5,dif-ferent from the temperaturefluctuations distribution which with-out the branch liquid distributor,there are two peaks of high fluctuation located at the90°and270°directions along with the tube.This is because the direction is that of the outlet of branch liquid distributor,the coldfluidflowing out from the outlet of branch liquid distributor mixes very fast with the hotfluid,leading to dramatic changes of temperature.In summary,the LES simulation results obtained are generally in good qualitative and quantitative agreement with the experi-mental data for the case of T-junction with/without the branch liquid distributor.Based on this,we analyzed the numerical results further.And the results are reported in the section below.4.2.Numerical results with/without branch liquid distributorThe numerical data were sampled on the inner wall in the plane x/ d m=À1,À0.5,0,0.5,1,2,3,4,6and8.At the same time,the numer-ical data were sampled from points every5mm along the intersec-tional lines of planes of y/d m=0and sections of x/d m=À2,À1,0,1,2, 3,4,5and6,to get the points with the maximum normalized rootK.Gao et al./Annals of Nuclear Energy78(2015)180–187185mean square temperatures in the tee and on the top and bottom walls.Here,the temperature and velocityfields were determined with LES simulations for the case of tee junction with/without branch liquid distributor.The temperature contours and velocity vectors for the T-junction are shown in Figs.12and13,respectively.As can be seen in Fig.12,due to the large branch pipeflow velocity,hot and coldfluid mixing zone is mainly located in both upstream and downstream region of the intersections of the main pipe and the branch pipe.The vigorous mixing offluids in the tube leads to thermalfluctuation on the wall.But in the T-junction with the branch liquid distributor,the mixing region moves to the lower half and downstream region of the main pipe.This indicates that the distributor is advantageous to weaken thermalfluctuations on the wall.The same conclusion can be seen from Fig.13,the dis-tributor weaken thermalfluctuations on the wall of downstream region and the top of the main pipe.186K.Gao et al./Annals of Nuclear Energy78(2015)180–187Fig.14compares the normalized mean temperatures between two tees of different structures.As can be seen,wall temperature changes great in the direction of90°,135°,225°and270°in T-junc-tion with the distributor,because the directions are the distributor outlet directions.This indicates that the coldfluid mixes with hot fluid on the wall afterflows out of the distributor.At the same time,the temperature in the direction of180°also changes dra-matically.That is because the coldfluid moves down in the effects of gravity and buoyancy.As shown in Fig.15,for the tee with distributor,the maximum values of normalized RMS temperature are smaller than that of the tee without distributor in most directions.This indicates that the adding of the distributor can relieve thermalfluctuations on the wall to some extent.And for the T-junction with distributor,tem-perature tends to be stable after the plane of x/d m=6,which indi-cates that twofluids have made a full mixing,while for the initial tee,temperature is still in the dramatic change,and this shows that the improved structure can effectively reduce the mixing length.Fig.16shows the maximum normalized instantaneous temper-aturefluctuations in the tee and on the top and bottom walls in the plane y/d m=0.In the tee,the maximum normalized instantaneous temperaturefluctuations of the case without distributor vary from 0.45to0.8,which means that the hot and coldfluids alternate in this location.However,for the case with distributor,the tempera-turefluctuations in the tee as well as on the top and bottom walls are much smaller than those of the case without distributor.That also implies that the distributor can reduce the temperaturefluctu-ation effectively.The normalized instantaneous temperaturefluctuations cannot describe the relationship between power spectrum density(PSD) and frequency of the temperaturefluctuation.PSD against fre-quency is one of the most important parameter for thermal fatigue analysis,which can directly show how PSD is in a certain fre-quency.The PSDs of the points with maximum temperaturefluctu-ation for the cases with and without distributor against frequency were recorded by fast Fourier transform(FFT)and shown in Fig.17. The temperaturefluctuation of the case without distributor has the highest PSD,at the frequency of0.04Hz,whereas the distributor significantly reduces the PSD of the temperaturefluctuations with the frequency from0.01to0.1Hz.In addition,the PSD of temper-aturefluctuations decreases with the frequency increasing.5.ConclusionsAs thermal stratification can result in thermal fatigue in the pip-ing system of a nuclear power plant,safety and integrity evaluation of the piping system has become an important issue.In this work the temperaturefluctuation has been studied by the experiment and numerically predicted by LES for two types of vertical tee junc-tion:one with distributor in the branch pipe and another without. The numerical results of normalized mean and RMS temperatures for the two structures have been found to be in good qualitative and quantitative agreement with the experimental data,which val-idates the use of LES simulations to evaluate convective mixing in such geometries.At the same time,the simulated normalized mean and root-mean square(RMS)temperature,velocity vector and temperature contour of the two tees are compared.The numerical results show that thefluctuations of temperatures of the tee without the distrib-utor are larger than those of the tee with the distributor,which can be explained by the branch liquid distributor enhancing the mix-ing.Although both tees give the same momentum ratio between the main pipeflow and the branch pipeflow,mixing and convec-tive heat transfer are greatly enhanced by the presence of the branch liquid distributor.These all show that the structure is effec-tive for weakening the thermalfluctuation of tee piping wall when hot and coldfluids mix,and it can make the mixing more sufficient.AcknowledgementsThis work was supported by projects of the National Natural Science Foundation of China(No.51276009),Program for New Century Excellent Talents in University(No.NCET-13-0651),and the National Basic Research Program of China(No.2011CB706900). 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Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common LinksCFR - Code of Federal Regulations Title 21510(k)|Registration & Listing |Adverse Events|Recalls |PMA |Classification |Standards CFR Title 21|Radiation-Emitting Products |X-Ray Assembler |Medsun Reports|CLIANew Search Help | More About 21CFRTITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER D--DRUGS FOR HUMAN USE[Code of Federal Regulations][Title 21, Volume 5][Revised as of April 1, 2010][CITE: 21CFR312] PART 312INVESTIGATIONAL NEW DRUGAPPLICATIONSubpart A--General ProvisionsSec. 312.1 Scope.(a) This part contains procedures and requirements governing theuse of investigational new drugs, including procedures andrequirements for the submission to, and review by, the Food andDrug Administration of investigational new drug applications(IND's). An investigational new drug for which an IND is ineffect in accordance with this part is exempt from thepremarketing approval requirements that are otherwise applicableand may be shipped lawfully for the purpose of conductingclinical investigations of that drug.(b) References in this part to regulations in the Code of FederalRegulations are to chapter I of title 21, unless otherwise noted.Sec. 312.2 Applicability.(a)Applicability. Except as provided in this section, this partapplies to all clinical investigations of products that aresubject to section 505 of the Federal Food, Drug, and CosmeticAct or to the licensing provisions of the Public Health ServiceAct (58 Stat. 632, as amended (42 U.S.C. 201et seq .)).(b)Exemptions. (1) The clinical investigation of a drug productthat is lawfully marketed in the United States is exempt from therequirements of this part if all the following apply:(i) The investigation is not intended to be reported to FDA as awell-controlled study in support of a new indication for use norintended to be used to support any other significant change in the labeling for the drug;(ii) If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;(iii) The investigation does not involve a route ofadministration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;(iv) The investigation is conducted in compliance with the requirements for institutional review set forth in part 56 and with the requirements for informed consent set forth in part 50; and(v) The investigation is conducted in compliance with the requirements of 312.7.(2)(i) A clinical investigation involving an in vitro diagnostic biological product listed in paragraph (b)(2)(ii) of this section is exempt from the requirements of this part if (a ) it is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure and (b ) it is shipped in compliance with 312.160.(ii) In accordance with paragraph (b)(2)(i) of this section, the following products are exempt from the requirements of this part: (a ) blood grouping serum; (b ) reagent red blood cells; and (c ) anti-human globulin.(3) A drug intended solely for tests in vitro or in laboratory research animals is exempt from the requirements of this part if shipped in accordance with 312.160.(4) FDA will not accept an application for an investigation that is exempt under the provisions of paragraph (b)(1) of this section.(5) A clinical investigation involving use of a placebo is exempt from the requirements of this part if the investigation does not otherwise require submission of an IND.(6) A clinical investigation involving an exception from informed consent under 50.24 of this chapter is not exempt from the requirements of this part.(c)Bioavailability studies. The applicability of this part to in vivo bioavailability studies in humans is subject to theprovisions of 320.31.(d)Unlabeled indication. This part does not apply to the use in the practice of medicine for an unlabeled indication of a newdrug product approved under part 314 or of a licensed biological product.(e)Guidance. FDA may, on its own initiative, issue guidance onthe applicability of this part to particular investigational uses of drugs. On request, FDA will advise on the applicability ofthis part to a planned clinical investigation.[52 FR 8831, Mar. 19, 1987, as amended at 61 FR 51529, Oct. 2, 1996; 64 FR 401, Jan. 5, 1999]Sec. 312.3 Definitions and interpretations.(a) The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:(b) The following definitions of terms also apply to this part:Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-902, 52 Stat. 1040et seq ., as amended (21 U.S.C. 301-392)).Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selectionor monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration.FDA means the Food and Drug Administration.IND means an investigational new drug application. For purposesof this part, "IND" is synonymous with "Notice of Claimed Investigational Exemption for a New Drug."Independent ethics committee (IEC) means a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An institutional review board (IRB), as defined in 56.102(g) of this chapter and subject to the requirements of part 56 of this chapter, is one type of IEC. Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug" and "investigational new drug" are deemed to be synonymous for purposes of this part.Investigator means an individual who actually conducts a clinical investigation (i.e. , under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. "Subinvestigator" includes any other individual member of that team.Marketing application means an application for a new drug submitted under section 505(b) of the act or a biologics license application for a biological product submitted under the Public Health Service Act.Sponsor means a person who takes responsibility for and initiatesa clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academicinstitution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than anindividual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not asponsor-investigator, and the employees are investigators. Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate directionthe investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor. Subject means a human who participates in an investigation,either as a recipient of the investigational new drug or as a control. A subject may be a healthy human or a patient with a disease.[52 FR 8831, Mar. 19, 1987, as amended at 64 FR 401, Jan. 5, 1999; 64 FR 56449, Oct. 20, 1999; 73 FR 22815, Apr. 28, 2008] Sec. 312.6 Labeling of an investigational new drug.(a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement "Caution: New Drug--Limited by Federal (or United States) law toinvestigational use."(b) The label or labeling of an investigational new drug shallnot bear any statement that is false or misleading in anyparticular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.(c) The appropriate FDA Center Director, according to the procedures set forth in 201.26 or 610.68 of this chapter, may grant an exception or alternative to the provision in paragraph (a) of this section, to the extent that this provision is not explicitly required by statute, for specified lots, batches, or other units of a human drug product that is or will be includedin the Strategic National Stockpile.[52 FR 8831, Mar. 19, 1987, as amended at 72 FR 73599, Dec. 28, 2007]Sec. 312.7 Promotion of investigational drugs.(a)Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drugbefore it is approved for commercial distribution.(b)Commercial distribution of an investigational new drug. A sponsor or investigator shall not commercially distribute or test market an investigational new drug.(c)Prolonging an investigation. A sponsor shall not undulyprolong an investigation after finding that the results of the investigation appear to establish sufficient data to support a marketing application.[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 19476, May 22, 1987; 67 FR 9585, Mar. 4, 2002; 74 FR 40899, Aug. 13, 2009] Sec. 312.8 Charging for investigational drugs under an IND.(a)General criteria for charging . (1) A sponsor must meet the applicable requirements in paragraph (b) of this section for charging in a clinical trial or paragraph (c) of this section for charging for expanded access to an investigational drug for treatment use under subpart I of this part, except that sponsors need not fulfill the requirements in this section to charge for an approved drug obtained from another entity not affiliated with the sponsor for use as part of the clinical trial evaluation(e.g., in a clinical trial of a new use of the approved drug, for use of the approved drug as an active control).(2) A sponsor must justify the amount to be charged in accordance with paragraph (d) of this section.(3) A sponsor must obtain prior written authorization from FDA to charge for an investigational drug.(4) FDA will withdraw authorization to charge if it determines that charging is interfering with the development of a drug for marketing approval or that the criteria for the authorization are no longer being met.(b)Charging in a clinical trial --(1)Charging for a sponsor'sdrug . A sponsor who wishes to charge for its investigational drug, including investigational use of its approved drug, must: (i) Provide evidence that the drug has a potential clinicalbenefit that, if demonstrated in the clinical investigations, would provide a significant advantage over available products in the diagnosis, treatment, mitigation, or prevention of a disease or condition;(ii) Demonstrate that the data to be obtained from the clinical trial would be essential to establishing that the drug iseffective or safe for the purpose of obtaining initial approvalof a drug, or would support a significant change in the labeling of an approved drug (e.g., new indication, inclusion of comparative safety information); and(iii) Demonstrate that the clinical trial could not be conducted without charging because the cost of the drug is extraordinary to the sponsor. The cost may be extraordinary due to manufacturing complexity, scarcity of a natural resource, the large quantity of drug needed (e.g., due to the size or duration of the trial), or some combination of these or other extraordinary circumstances(e.g., resources available to a sponsor).(2)Duration of charging in a clinical trial . Unless FDAspecifies a shorter period, charging may continue for the length of the clinical trial.(c)Charging for expanded access to investigational drug for treatment use . (1) A sponsor who wishes to charge for expanded access to an investigational drug for treatment use under subpart I of this part must provide reasonable assurance that chargingwill not interfere with developing the drug for marketing approval.(2) For expanded access under 312.320 (treatment IND or treatment protocol), such assurance must include:(i) Evidence of sufficient enrollment in any ongoing clinicaltrial(s) needed for marketing approval to reasonably assure FDA that the trial(s) will be successfully completed as planned;(ii) Evidence of adequate progress in the development of the drug for marketing approval; and(iii) Information submitted under the general investigationalplan (312.23(a)(3)(iv)) specifying the drug developmentmilestones the sponsor plans to meet in the next year.(3) The authorization to charge is limited to the number of patients authorized to receive the drug under the treatment use, if there is a limitation.(4) Unless FDA specifies a shorter period, charging for expanded access to an investigational drug for treatment use under subpart I of this part may continue for 1 year from the time of FDA authorization. A sponsor may request that FDA reauthorizecharging for additional periods.(d)Costs recoverable when charging for an investigational drug .(1) A sponsor may recover only the direct costs of making its investigational drug available.(i) Direct costs are costs incurred by a sponsor that can be specifically and exclusively attributed to providing the drug for the investigational use for which FDA has authorized cost recovery. Direct costs include costs per unit to manufacture the drug (e.g., raw materials, labor, and nonreusable supplies and equipment used to manufacture the quantity of drug needed for the use for which charging is authorized) or costs to acquire thedrug from another manufacturing source, and direct costs to ship and handle (e.g., store) the drug.(ii) Indirect costs include costs incurred primarily to produce the drug for commercial sale (e.g., costs for facilities and equipment used to manufacture the supply of investigational drug, but that are primarily intended to produce large quantities of drug for eventual commercial sale) and research and development, administrative, labor, or other costs that would be incurred even if the clinical trial or treatment use for which charging is authorized did not occur.(2) For expanded access to an investigational drug for treatment use under 312.315 (intermediate-size patient populations) and312.320 (treatment IND or treatment protocol), in addition to the direct costs described in paragraph (d)(1)(i) of this section, a sponsor may recover the costs of monitoring the expanded access IND or protocol, complying with IND reporting requirements, and other administrative costs directly associated with the expanded access IND.(3) To support its calculation for cost recovery, a sponsor must provide supporting documentation to show that the calculation is consistent with the requirements of paragraphs (d)(1) and, if applicable, (d)(2) of this section. The documentation must be accompanied by a statement that an independent certified public accountant has reviewed and approved the calculations.[74 FR 40899, Aug. 13, 2009]Sec. 312.10 Waivers.(a) A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to contain at least one ofthe following:(1) An explanation why the sponsor's compliance with the requirement is unnecessary or cannot be achieved;(2) A description of an alternative submission or course ofaction that satisfies the purpose of the requirement; or(3) Other information justifying a waiver.(b) FDA may grant a waiver if it finds that the sponsor's noncompliance would not pose a significant and unreasonable risk to human subjects of the investigation and that one of the following is met:(1) The sponsor's compliance with the requirement is unnecessary for the agency to evaluate the application, or compliance cannot be achieved;(2) The sponsor's proposed alternative satisfies the requirement; or(3) The applicant's submission otherwise justifies a waiver.[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9585, Mar. 4, 2002]Subpart B--Investigational New Drug Application (IND)Sec. 312.20 Requirement for an IND.(a) A sponsor shall submit an IND to FDA if the sponsor intendsto conduct a clinical investigation with an investigational new drug that is subject to 312.2(a).(b) A sponsor shall not begin a clinical investigation subject to 312.2(a) until the investigation is subject to an IND which is ineffect in accordance with 312.40.(c) A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent under 50.24 of this chapter. Such a clinical investigation is not permitted to proceed without the prior written authorization from FDA. FDA shall provide a written determination 30 days after FDA receives the IND or earlier.[52 FR 8831, Mar. 19, 1987, as amended at 61 FR 51529, Oct. 2, 1996; 62 FR 32479, June 16, 1997]Sec. 312.21 Phases of an investigation.An IND may be submitted for one or more phases of aninvestigation. The clinical investigation of a previouslyuntested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap. These three phases of an investigation are a follows:(a)Phase 1. (1) Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies aretypically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed todetermine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and,if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80.(2) Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.(b)Phase 2. Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for aparticular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conductedin a relatively small number of patients, usually involving no more than several hundred subjects.(c)Phase 3. Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminaryevidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually includefrom several hundred to several thousand subjects.Sec. 312.22 General principles of the IND submission.(a) FDA's primary objectives in reviewing an IND are, in allphases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug's effectiveness and safety. Therefore, although FDA's review of Phase 1 submissions will focus on assessing the safety of Phase 1 investigations, FDA's review of Phases 2 and 3 submissions will also include an assessment of the scientific quality of the clinical investigations and thelikelihood that the investigations will yield data capable of meeting statutory standards for marketing approval.(b) The amount of information on a particular drug that must be submitted in an IND to assure the accomplishment of theobjectives described in paragraph (a) of this section depends upon such factors as the novelty of the drug, the extent to which it has been studied previously, the known or suspected risks, and the developmental phase of the drug.(c) The central focus of the initial IND submission should be on the general investigational plan and the protocols for specific human studies. Subsequent amendments to the IND that contain new or revised protocols should build logically on previous submissions and should be supported by additional information, including the results of animal toxicology studies or other human studies as appropriate. Annual reports to the IND should serve as the focus for reporting the status of studies being conducted under the IND and should update the general investigational plan for the coming year.(d) The IND format set forth in 312.23 should be followedroutinely by sponsors in the interest of fostering an efficient review of applications. Sponsors are expected to exercise considerable discretion, however, regarding the content of information submitted in each section, depending upon the kind of drug being studied and the nature of the available information. Section 312.23 outlines the information needed for a commercially sponsored IND for a new molecular entity. A sponsor-investigator who uses, as a research tool, an investigational new drug that is already subject to a manufacturer's IND or marketing application should follow the same general format, but ordinarily may, if authorized by the manufacturer, refer to the manufacturer's INDor marketing application in providing the technical information supporting the proposed clinical investigation. A sponsor-investigator who uses an investigational drug not subject to a manufacturer's IND or marketing application is ordinarilyrequired to submit all technical information supporting the IND, unless such information may be referenced from the scientific literature.Sec. 312.23 IND content and format.(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an "Investigational New Drug Application" (IND) including, in the following order:(1)Cover sheet (Form FDA-1571). A cover sheet for the application containing the following:(i) The name, address, and telephone number of the sponsor, the date of the application, and the name of the investigational new drug.(ii) Identification of the phase or phases of the clinical investigation to be conducted.(iii) A commitment not to begin clinical investigations until an IND covering the investigations is in effect.(iv) A commitment that an Institutional Review Board (IRB) that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of each of the studies in the proposed clinical investigation and that the investigator will report to the IRB proposed changes in the research activity in accordance with the requirements of part 56.(v) A commitment to conduct the investigation in accordance with all other applicable regulatory requirements.(vi) The name and title of the person responsible for monitoring the conduct and progress of the clinical investigations.(vii) The name(s) and title(s) of the person(s) responsible under 312.32 for review and evaluation of information relevant to the safety of the drug.(viii) If a sponsor has transferred any obligations for the conduct of any clinical study to a contract researchorganization, a statement containing the name and address of the contract research organization, identification of the clinical study, and a listing of the obligations transferred. If all obligations governing the conduct of the study have been transferred, a general statement of this transfer--in lieu of a listing of the specific obligations transferred--may besubmitted.(ix) The signature of the sponsor or the sponsor's authorized representative. If the person signing the application does not reside or have a place of business within the United States, the IND is required to contain the name and address of, and be countersigned by, an attorney, agent, or other authorizedofficial who resides or maintains a place of business within the United States.(2)A table of contents.(3)Introductory statement and general investigational plan. (i) A brief introductory statement giving the name of the drug and all active ingredients, the drug's pharmacological class, thestructural formula of the drug (if known), the formulation of the dosage form(s) to be used, the route of administration, and the broad objectives and planned duration of the proposed clinical investigation(s).(ii) A brief summary of previous human experience with the drug, with reference to other IND's if pertinent, and toinvestigational or marketing experience in other countries that may be relevant to the safety of the proposed clinicalinvestigation(s).(iii) If the drug has been withdrawn from investigation or marketing in any country for any reason related to safety or effectiveness, identification of the country(ies) where the drug was withdrawn and the reasons for the withdrawal.(iv) A brief description of the overall plan for investigatingthe drug product for the following year. The plan should include the following: (a ) The rationale for the drug or the research study; (b ) the indication(s) to be studied; (c ) the general approach to be followed in evaluating the drug; (d ) the kinds of clinical trials to be conducted in the first year following the submission (if plans are not developed for the entire year, the sponsor should so indicate); (e ) the estimated number ofpatients to be given the drug in those studies; and (f ) anyrisks of particular severity or seriousness anticipated on the basis of the toxicological data in animals or prior studies in humans with the drug or related drugs.(4) [Reserved](5)Investigator's brochure. If required under 312.55, a copy of the investigator's brochure, containing the followinginformation:(i) A brief description of the drug substance and theformulation, including the structural formula, if known.(ii) A summary of the pharmacological and toxicological effectsof the drug in animals and, to the extent known, in humans.(iii) A summary of the pharmacokinetics and biologicaldisposition of the drug in animals and, if known, in humans.(iv) A summary of information relating to safety andeffectiveness in humans obtained from prior clinical studies. (Reprints of published articles on such studies may be appended when useful.)(v) A description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and of precautions orspecial monitoring to be done as part of the investigational use of the drug.(6)Protocols. (i) A protocol for each planned study. (Protocols for studies not submitted initially in the IND should besubmitted in accordance with 312.30(a).) In general, protocolsfor Phase 1 studies may be less detailed and more flexible than protocols for Phase 2 and 3 studies. Phase 1 protocols should be directed primarily at providing an outline of the investigation--an estimate of the number of patients to be involved, adescription of safety exclusions, and a description of the dosing plan including duration, dose, or method to be used indetermining dose--and should specify in detail only thoseelements of the study that are critical to safety, such as necessary monitoring of vital signs and blood chemistries. Modifications of the experimental design of Phase 1 studies that do not affect critical safety assessments are required to be reported to FDA only in the annual report.(ii) In Phases 2 and 3, detailed protocols describing all aspects of the study should be submitted. A protocol for a Phase 2 or 3 investigation should be designed in such a way that, if the sponsor anticipates that some deviation from the study design may become necessary as the investigation progresses, alternatives or contingencies to provide for such deviation are built into the protocols at the outset. For example, a protocol for a controlled short-term study might include a plan for an early crossover of。

临床试验常见英文缩写临床试验常见英文缩写ADR（Adverse drug reaction）不良反应AE（Adverse event）不良事件SAE（Serious Adverse Event）严重不良事件CRF（Case report form/case record form）病例报告表CRO（Contract research organization）合同研究组织EC（Ethics Committee）伦理委员会GCP（Good clinical practice）药品临床试验管理规范EDC（Electronic data capture）电子数据采集IB（Investigator's Brochure）研究者手册ND (Not Done) 未做NA (Not Applicable) 不适用UK (Unknown) 未知PI（Principal investigator ）主要研究者Sub-I(Sub-investigator) 助理研究者QA(Quality assurance) 质量保证QC(Quality control) 质量控制SDV（Source data verification）原始资料核对SD（Source data）原始数据SD(Source document ) 原始文件SFDA 国家食品药品监督管理局SOP(Standard operating procedure) 标准操作规程IRB 机构审查委员会ICF(Informed Consent Form) 知情同意书TMF（trial master file）研究管理文件夹临床试验常见英文单词AActive control ,AC 阳性对照，活性对照阳性对照，活性对照?Adverse drug reaction ,ADR 药物不良反应药物不良反应?Adverse event ,AE 不良事件Approval 批准Assistant investigator 助理研究者Audit 稽查Audit report 稽查报告Auditor 稽查员BBias 偏性，偏倚Blank control 空白对照Blinding/masking 盲法，设盲Block 层CCase history 病历Case report form/case record form ,CRF 病例报告表，病例记录表?Clinical study 临床研究Clinical trial 临床试验Clinical trial application ,CTA 临床试验申请Clinical trial exemption ,CTX 临床试验免责Clinical trial protocol ,CTP 临床试验方案Clinical trial/study report 临床试验报告COA(药品检测报告)Co-investigator 合作研究者Comparison 对照Compliance 依从性Computer-assisted trial design ,CATD 计算机辅助试验设计?Contract research organization ,CRO 合同研究组织Contract/agreement 协议/合同Coordinating committee 协调委员会Coordinating investigator 协调研究者Cross-over study 交叉研究Cure 痊愈CTRB 临床试验文件夹DDocumentation 记录/文件Dose-reaction relation 剂量—反应关系Double blinding 双盲Double dummy technique 双盲双模拟技术EElectronic data capture ,EDC 电子数据采集系统Electronic data processing ,EDP 电子数据处理系统Endpoint criteria/measurement 终点指标Essential documentation 必需文件Excellent 显效Exclusion criteria 排除标准FFailure 无效，失败Final report 总结报告Final point 终点Forced titration 强制滴定G&HGlobal 全球Generic drug 通用名药Good clinical practice ,GCP 药物临床试验质量管理规定Good manufacture practice ,GMP 药品生产质量管理规范Good non-clinical laboratory practice ,GLP 药物非临床研究质量管理规范?Health economic evaluation ,HEV 健康经济学评价Hypothesis testing 假设检验IImprovement 好转Inclusion criteria 入选标准Independent ethics committee ,IEE 独立伦理委员会?Information gathering 信息收集Informed consent form ,ICF 知情同意书Informed consent ,IC 知情同意Initial meeting 启动会议Inspection 视察/检查Institution inspection 机构检查Institutional review board ,IBR 机构审查委员会Intention to treat 意向治疗Interactive voice response system ,IVRS 互动式语音应答系统?International Conference on Harmonization ,ICH 国际协调会议?Investigational new drug ,IND 新药临床研究?Investigational product 试验药物Investigator 研究者Investigator’s brochure ,IB 研究者手册LLocal 局部M&NMarketing approval/authorization 上市许可证Matched pair 匹配配对Monitor 监查员Monitoring 监查Monitoring report 监查报告Multi-center trial 多中心试验New chemical entity ,NCE 新化学实体New drug application ,NDA 新药申请Non-clinical study 非临床研究OObedience 依从性Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标PPatient file 病人指标Patient history 病历Placebo 安慰剂Placebo control 安慰剂对照Preclinical study 临床前研究Principle investigator ,PI 主要研究者Product license ,PL 产品许可证Protocol 试验方案Protocol amendment 方案补正Q&RQuality assurance ,QA 质量保证Quality assurance unit ,QAU 质量保证部门?Quality control ,QC 质量控制?Randomization 随机Regulatory authorities ,RA 监督管理部门?Replication 可重复Run in 准备期SSample size 样本量，样本大小Serious adverse event ,SAE 严重不良事件?Serious adverse reaction ,SAR 严重不良反应?Seriousness 严重性Severity 严重程度Simple randomization 简单随机Single blinding 单盲Site audit 试验机构稽查Source data ,SD 原始数据Source data verification ,SDV 原始数据核准?Source document ,SD 原始文件Sponsor 申办者Sponsor-investigator 申办研究者Standard operating procedure ,SOP 标准操作规程?Statistical analysis plan ,SAP 统计分析计划?Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code ,SIC 受试者识别代码?Subject recruitment 受试者招募Subject screening log 受试者筛选表System audit 系统稽查T&UTrial error 试验误差Trial master file 试验总档案Trial objective 试验目的Trial site 试验场所Triple blinding 三盲Unblinding 破盲Unexpected adverse event ,UAE 预料外不良事件V&WVariability 变异Visual analogy scale 直观类比打分法Vulnerable subject 弱势受试者Wash-out 清洗期Well-being 福利，健康EDC 系统常见英文缩写1.SCR (screening) 筛选2.DOV (date of visit) 访视第一天3.ELIG ( ELIGIBILITY ) 入排合格4.DEM ( DEMOGRAPHY )人口统计学5.MEDSX (medical history) 既往史MHX1 : CANCER RELATED CURRENT MEDICAL CONDITIONS 该肿瘤手术史及肿瘤相关症状MHX2 : NON-CANCER RELATED MEDICAL CONDITIONS与该肿瘤无关的病史6.VS /VITALS ( VITAL SIGNS ) 生命体征7.ECOG/PS 体能评分note：后面具体讲解8. ECG : 12-LEAD ECG 心电图9. ECHO ( ECHOCARDIOGRAM ) 超声心动图10. HAEMA ( LOCAL LABORATORY –HAEMATOLOGY )血常规11. CHEM ( LOCAL LABORATORY –CLINICAL CHEMISTRY )血生化12. URIN ( urine ) 尿常规13. C1 ( Cycle1 ) 第一周期14. WD : End of Therapy/DISCONTINUATION 结束治疗(停止用药)15. FU ( Follow-up ) 随访16.CMED( CONCOMITANT MEDICATIONS ) 伴随药物17. AE ( NON-SERIOUS ADVERSE EVENTS ) 不良事件18. SAE ( SERIOUS ADVERSE EVENTS ) 严重不良事件19. EOS( End of Study ) 结束研究：肿瘤以病人死亡事件为准20. UNS ( Unscheduled Visit ) 不预期访问21.ND (Not Done) 未做22. NA (Not Applicable) 不适用/doc/4d16409753.html, (Unknown) 未知临床试验常见语句描述一. 临床试验过程描述1）一般描述：1. Subject was diagnosed with XX in September, 2010, and had XX surgery in December, 2010.患者于2010 年9 月确诊XX 疾病，于2010 年12 月行XX 术。