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OptionalEasy to use tray for product water intakeYamato Scientific America Inc.Membrane Filter (Standard)Ion-exchange resin life span test (resistivity)Deionized waterDeionized waterWG250B/1000119CATV1-201701Raw waterDrain trap OWI10+stand AS250Product water hose (OWG24)Feed water connection (OWH10)Membrane filter MFRL727Air vent filter for tank AVF-1cartridge (PWF-1) removes trihalomethane and achieves higher water quality (2) Ion-exchange resin cartridge (CPC-S)2413Yamato Scientific America Inc.WG250B/1000CATV1-2017011205904551351557039Membrane filter Tank air vent filterAVF-1 (4210)organic and dustHigh performance ion-exchange resin cartridge (CPC-S, 4L) brings high purity water with low electric conductivity and TOC Optional membrane filter at water sampling port Displays replacement of consumablesFeed / Drain water connectors on both sides* Protrusions not included.Drain trap + StandStand Water supply port unit * Please specify when ordering main unit.Yamato Scientific America Inc.WG203CATV1-201701121 Yamato Scientific America Inc.122 CATV1-201701ASTM D1193 Type1 / JIS K 0557 A4 levelhigh purity water with reduced TOC valueEmploys microprocessor which auto-matically controls all processes fromsupplying of water, ion exchange anddistillation to storageEquipped with high performance pre-treatment cartridge (activated charcoal +0.1µm hollow fiber membrane) for highquality waterStandard equipped with 0.1µm hollowfiber membrane filter at water samplingports which protects pure water deliveryfrom contaminationInitial distilled water drainage, automaticboiler cleaning and drainage device forstable quality of distilled waterSafety device includes low-water boilingprevention, overheat prevention, waterleak detector, earth leakage circuitbreakerWA570WA730(1)(2)(3)Water supply port unitHigh purity cartridgePre-treatment cartridge Ion-exchange resin cartridgeWS200WS220Simple and economical water purifier designed for distilled water productionSpace saving and compactBy adopting splash prevention design, impurities are prevented from mixing with the distilled water, resulting to a stable water quality D esigned with empty boiling prevention and overheat prevention functionsSuitable as washing water for cleaning tools, glassware, etc.*Protrusions not includedOptional itemsConsumable partsMembrane filterPre-treatment cartridge Water sampling stand Foot switchIon-exchange resin cartridge CPC-TReverse osmosis (RO) membrane cartridge setCollecting deionized water is as simple as connecting to a faucetBenchtop, space-saving design Digital display for easy operationDeionized water compliant with ASTM D1193 Type 2 / JIS K 0557 A3 level, suitable for trace analysisDisplays replacement of consumablesStandard equipped with membrane filter (WL200/220)A solenoid valve at the water sampling port prevents water leakage from final membrane filterWL220T is equipped with constant temperature control and pure water tank. Constant tempera-ture and deionized water delivery to pure water tank controlled by electromagnetic valve*Protrusions not included.WL200WL220WL220TSpecificationsWater supply port unit OWH10Shelf plate (OWL50): used when WL220T is placed on top of the constant temperature control plateConsumablesMembrane filter CPC-P Ion exchange resin cartridge CPC-E Ion exchange resin cartridgeWL220Ton a tableDeionized water compliant with ASTM D1193 Type2/ JIS K 0557 A4 level, suitable for high sensitivitytrace analysisEasy operating digital displayStandard equipped with membrane filter at waterfeeding portEquipped with water leak detection function thatstops water supply in case water leak occurs, byactivating the electric leakage breakerDisplays replacement of consumablesWL320Bare required: WL320 + 253277 + 253276 (with foot switch)(1) (2)Foot switch (optional)Water Quality AnalysisItemASTM D 1193 Standard Type 1JIS K 0057Standard A4Electrical conductivity (µS/cm)<0.056<1Organic carbon (µg /l)<50<50Zinc (µg Zn/l)-<0.1Silica (µg SiO 2/l)<3<2.5Chloride ion (µ Cl _/l)<1<1_。

constructionandbuildingmaterialsBehavior and mix design development of concrete made with recycled aggregate from deconstructed lead-contaminated masonry materialsJ.Hu a ,?,K.Wang b ,J.A.Gaunt ba Department of Engineering Technology,Texas State University-San Marcos,San Marcos,TX 78666,United StatesbDepartment of Civil,Construction and Environmental Engineering,Iowa State University,Ames,IA 50011,United Statesa r t i c l e i n f o Article history:Available online xxxx Keywords:Aggregate Cement Concrete Lead Masonry Nomograph Recycleda b s t r a c tThe present study is to develop an effective method for using deconstructed,lead-contaminated masonry materials in new concrete so as to minimize the environmental impact,cost,and time of the deconstruc-tion.The approach to this method is to use crushed masonry materials to replace natural aggregate in conventional concrete.Two different types of masonry materials (concrete blocks and clay bricks)were collected,painted with lead-based paint (LBP),and then crushed to simulate recycled LBP-contaminated masonry materials.Three types of cement (type I Portland cement,Calcium Sulfoaluminate (CSA)cement,and Portland cement with 5%phosphate addition)were selected for sequestering lead in the recycled aggregate.A concrete mix design matrix was developed with different water-to-cement ratios (w/c),aggregate-to-cement ratios (a/c),types of cements,and types of masonry materials.Based on the test results,mix design nomographs were developed for concrete made with the recycled,LBP-contaminated masonry materials.The results indicate that the lead can be sequestered,or rendered non-leachable,due to the high alkalinity of cement.The concrete therefore no longer has the toxicity characteristic for lead and is suitable for various types of new construction,such as foundation and pavement,reinforced beams,columns,and walls.ó2012Elsevier Ltd.All rights reserved.1.IntroductionIn the United States,many masonry structures built before 1980s contain lead-based paint (LBP),which causes a considerable environmental and health concern.Both the US Environmental Protection Agency (EPA)and the Occupational Safety and Health Administration (OSHA)have established regulations governing the management of LBP in buildings.Deconstruction of these struc-tures is often time consuming and costly due to the paint removal and the hazardous material disposal [1–3].Clearly,a more cost effective,environmentally friendly method is urgently needed for remediating and reusing deconstructed masonry materials con-taminated with LBP.From a chemical point view,the degree of the hazard resulting from LBP is often de?ned by the solubility of lead in a material.The solubility of lead in a material is generally controlled by the pH or alkalinity of the material.The Eh–pH diagram for an aqueous lead-carbonate system indicates that lead will be insoluble if the system has a pH value above 6or 7[4–6].In a cement-based material,the pH values of pore solutions often range from 11to 13,thus possi-bly sequestering lead in the material.Using the above-mentioned concept,a study has been con-ducted to sequester lead by recycling the lead-contaminated deconstruction masonry materials as concrete aggregate.A key of this study is to design rational mix proportions so that the concrete cannot only sequester lead in the recycled aggregate but also meet general concrete construction and structural performance require-ments,such as having proper workability and strength.This paper presents a rational mix design method for proportioning non-hazardous,well-performing,sustainable concrete utilizing the recycled,lead-contaminated aggregate for ?eld construction.The mix design development includes three major steps:(1)characterizing the recycled masonry materials –evaluating their toxicity,speci?c gravity,absorption,and strength,(2)proportion-ing concrete mixtures based on workability control –designing concrete mixtures to have low,medium and high slumps so as to permit the concrete to be used for different construction applica-tions,and (3)performance evaluation –examining the lead leach-ing ability or sequestering effectiveness and strength of the concrete containing recycled,lead-contaminated deconstruction masonry materials.As a result,a series of mix design nomograms are established that illustrate the relationships between the mix proportion parameters (such as water-to-cement ratio,aggre-gate-to-cement ratio,and cement content)and concrete perfor-mance (such as lead sequestering effectiveness and strength).0950-0618/$-see front matter ó2012Elsevier Ltd.All rights reserved.doi:10.1016/j.conbuildmat.2011.07.067Corresponding author.Tel.:+15122456328;fax:+15122453052.E-mail address:jiong.hu@/doc/0fc77951804d2b160b4ec0fb.html (J.Hu).prepared (Table 2).Air entraining agent with the recommended dosage was used in all of the concrete mixes studied.2.3.Test methodsPhysical properties of the masonry materials were characterized,and their total and leachable lead contents were evaluated.The speci?c gravity and absorption of the crushed masonry materials were measured according to ASTM C127and ASTM C128.Sieving analysis and bulk density (unit weight)tests were conducted for the painted and crushed masonry materials according to ASTM C136,and ASTM C29respectively.The leachability of lead from the LBP-painted recycled aggregates and the concrete mixes made with those aggregates was tested using the Toxicity Characteristic Leaching Procedure (TCLP),EPA Method 1311[9].The total lead con-tent in the materials was also evaluated using the California Waste Extraction Test (WET)[10].Concrete was mixed based on the ASTM C192multiple-step mixing procedure.The slump of fresh concrete was measured according to ASTMC143immediately after mixing.In this study,the slump test was not only a measurement to evaluate the workability of concrete,more importantly,the slump value was used as a con-trol parameter for concrete mix design.Different slumps are required for different concrete construction applications.Concretes with three different ranges of slumps were designed:(1)25–50mm slump for low workability concrete (generally used for pavements and slabs),(2)75–100mm slump for medium workability concrete (generally used for beams,walls,columns,reinforced concrete),and (3)150–175mm slump for high workability concrete (generally used for heavily reinforced components with complicated shapes).The entire sample preparation and curing process followed ASTM C192.Compressive strength of hardened concrete was tested at the age of 3,7and 28days according to ASTM C39.The broken specimens from compression testing were further processed and then used for the TCLP soluble and total lead content (WET)tests.3.Results and discussion3.1.Characterization of recycled,LBP-contaminated aggregate Table 3presents the physical properties and lead content of the lead-contaminated masonry materials used.The test results indi-Table 1Oxide and chemical composition of cement (%).CaOSiO 2Al 2O 3Fe 2O 3MgO SO 3TiO 2Oxide composition (%)Portland cement 62.9620.96 4.54 3.48 2.91 2.77–CSA cement40.00 5.5537.50 1.50 1.7510.00 1.25C 3SC 2S C 3A C 4AF Gypsum Ca 4Al 6O 12SO 4Chemical composition (%)Portland cement 53.7119.58 6.1410.590.78–CSA cement0.4212.5910.64–1.0773.37Fig.1.Painting with LBP.Fig.2.Crushing of LBP contaminated masonry materials.cated that the recycled masonry materials had lower speci?c grav-ity (2.34–2.39)than natural aggregate (2.5–2.9),while the absorp-tion of the recycled aggregate (5.11–7.11%)was much higher than natural aggregate (0.2–4.0%)[11,12].The void contents of the four(a) Masonry A (b) Masonry BTable 2Concrete mix proportions.CementMasonry a/c w/c C (kg/m 3)Cement Masonry a/c w/c C (kg/m 3)1Portland A 3.00.2850025Portland C 6.00.362662Portland A 3.00.3145626Portland C 6.00.422653Portland A 3.00.3247727Portland C 6.00.442554Portland A 4.50.3234828Portland D 3.00.394835Portland A 4.50.3433029Portland D3.00.434756Portland A4.50.3732130Portland D 3.00.484367Portland A 6.00.3426531Portland D 4.50.503408Portland A 6.00.3626632Portland D4.50.523299Portland A 6.00.4125433Portland D 4.50.5633410Portland B 3.00.3450634Portland D 6.00.5626711Portland B 3.00.3547135Portland D 6.00.6025712Portland B 3.00.4047336Portland D 6.00.7425313Portland B 4.50.3935137CSA B 3.00.4546814Portland B 4.50.4231838CSA B4.50.4635415Portland B 4.50.4831739CSA B 6.00.5026916Portland B 6.00.4526940CSA D 3.00.4647017Portland B 6.00.4825641CSA D4.50.5134918Portland B 6.00.5523642CSAD 6.00.6126519Portland C 3.00.3049943Phosphate B 3.00.3748320Portland C 3.00.3348644Phosphate B 4.50.4134921Portland C3.00.3647545Phosphate B 6.00.4925322Portland C4.50.3333946Phosphate D 3.00.4347323Portland C 4.50.3634447Phosphate D 4.50.5333624 PortlandC4.50.3933448PhosphateD6.00.62263Note :Here,a/c is aggregate-to-cement ratio;w/c is water-to-cement ratio;and C is cement factor.J.Hu et al./Construction and Building Materials xxx (2012)xxx–xxx3and 10.1g/Kg,larger than 1g/Kg,which shall be de?ned as hazard materials based on the California regulation.masonry C and D had TCLP lead content of 142and 77mg/L and the total lead content from WET tests of 12.5and 5.82g/Kg,which were de?ned as haz-ard materials based on both the RCRA and California regulations.The critical issue in the present study is to ?nd out whether or not the concrete made with these hazard materials still have tox-icity characteristic.3.2.Lead content and lead leachability of concreteThe above mentioned lead-contaminated masonry materials were crushed and used as aggregate in the concrete mixes as de-signed in Table 1.The TCLP lead,TCLP pH and total lead of the 48designed mixes were determined at the concrete age of 28-days.Results of compressivestrengths,together with lead content and lead leachability of all 48mixes can be found in Table 4.Detailed test results and analysis can be found in Wang et al.[8].Fig.5presents the TCLP pH value and leachable Pb content of concrete mixes studied.Although the total lead in the concrete mixes were high (up to 2.2%),the ?gure shows that all concrete mixes studied,except four mixes with masonry material D,had TCLP leachable Pb content less than1mg/L,much lower than the RCRA limit of 5mg Pb/L.As a result,these concrete mixes are con-sidered as nonhazardous materials under RCRA although their aggregate is hazardous.The four mixes that showed hazard charac-teristic were mixes 34and 36(Table 1),which had a high a/c(6.0)and low Portland cement content (267and 253kg/m 3)and mixes 40and 42,which was made of CSA cement with a/c of 6.0and3.0respectively.The result is probably due to the fact that the CSA cement was less alkaline than Portland cement,and the con-crete made with CSA cement had lower pH values than the corre-sponding concrete made with Portland cement,thus being less effective for sequestering lead in the concrete.A mix design withhigher cement content or high alkaline cement may be used to in-crease the alkalinity of the concrete and reduce its TCLP Pb value.Addition of5%phosphate in Portland cement did not signi?-cantly change the TCLP lead concentrations and total lead in the concrete.It is believed that if highly insoluble hydroxypyromorph-ite [Pb 5(PO 4)3OH]was formed in the concrete system through the lead phosphate reaction,it would have sequestered lead from the highly acidic conditions of the total lead test.This might have sug-gested a means for rendering LBP-contaminated masonry nonhaz-ardous under California law.This reaction,however,did not occur in the present study.The concentrations of phosphate added ran-ged from 31%to 62%of the amounts needed to stoichiometrically convert the lead in the concrete to hydroxypyromorphite but did not result in proportionate reductions in detectable total /doc/0fc77951804d2b160b4ec0fb.html pressive strength of concreteCompressive strength of all concrete mixes was tested at ages of 3days,7days,and 28days.Fig.6illustrates the effects of materials and mix parameters on the concrete strength.The trends of the ef-fects were similar for the concrete at three different testing ages.Generally,concrete strength decreased with increased water-to-cement ratios (w/c)and aggregate-to-cement ratios (a/c).As observed in Fig.6,for a given w/c,masonry B and D resulted in higher concrete strength than masonry A and C,which is prob-ably related to the concrete workability and strength of the recy-cled aggregate,respectively.For a given mix proportion,concrete made with CSA cement provided higher early age compressive strength than the corresponding concrete made with Portland ce-ment.The large strength and workability ranges imply that,with appropriate design,the concrete made with recycled aggregate from deconstructed masonry materials can be used for variousTable 3Physical properties and lead content of lead-contraindicated masonry materials.Concrete blocks Clay bricks AB C D Speci?c gravity 2.34 2.39 2.37 2.39Absorption (%)7.70 5.95 6.52 5.11Voids between aggregate particle (compacted)(%)36.7937.2041.3239.92Voids between aggregate particle (uncompacted) (%)38.5241.9847.746.33Compressive strength (MPa)21.0732.7973.65101.53TCLP pH6.737.02 5.11 4.88TCLP Pb,mg/L (toxicity limit:5mg/L) 4.17 1.2914277WET Total Pb,g/Kg (toxicity limit:1g/Kg)15.410.112.55.82Note :The underlined values indicate that these materials are classi?ed as toxic materials based on RCRA or California regulations.4.Gradation of the aggregate recycled masonry materials studied.(Note:DOT-C3and C4are natural aggregate used for conventional pavement concrete USA)types of constructions,such as foundation,pavement,reinforced beams,columns,and walls.A cost effective analysis by the authorsshowed that a signi?cant saving can be achieved by using LBP-con-taminated masonry materials as recycled aggregate in concrete.The cost savings may result from eliminating LBP removal and waste material disposal,which will minimize the use of secure land?lls,eliminate the time and equipment required for sieving and re-grading recycled aggregate,and reduce natural aggregate consumption for concrete construction.Details of this cost effec-tive analysis can be found in a separated publication [13].4.Mix design nomograph developmentIn the present study,a nomograph was developed for concrete made with each type of recycled,LBP-contaminated aggregate and/doc/0fc77951804d2b160b4ec0fb.html ing the mix design nomograph,proper mix propor-tions can be selected for the desired workability and strength.The nomograph combines three relationships developed for the prop-erties of fresh and hardened concrete into one graph.The mix de-sign nomograph uses three correlations:Abrams’law,Lyse’s law,and Molinari’s law [14,15].Abrams’law correlates the compressive strength of concrete with the w/c as:f 0c ?k 1k w =c2e1Twhere k 1,and k 2are constants depending on the materials used.Lyse’s law correlates the water-to-cement ratio (w/c)with the aggregate-to-cement ratio (a/c)(by weight)as:ea =c T?k 3ew =c Ttk 4e2Twhere a/c is the aggregate-to-cement ratio,k 3,and k 4are constants depend on the materials used.Molinari’s law correlates the cement content and aggregate-to-cement ratio as:C ?1000k 5ea =c Ttk 6e3Twhere C is the cement content,k 5,and k 6are constants depend on the materials used.Fig.6shows samples of general mix design nomograph.The nomograph can be used to determine the concrete mix proportion (a)for a given compressive strength but different workability (slump)requirements (Fig.7a)or (b)for a given workability but different strength requirements (Fig.7b).As shown in Fig.6a,according to the required compressive strength f 0c ;1;2;3,one can determined the w/c for concrete mixtures (w/c1,2,3)throughTable 4Compressive strength,lead content and lead-leachability of concrete mixtures.f 0c ;3(MPa)f 0c ;7(MPa)f 0c ;28(MPa)TCLP pH TCLP Pb (mg/L)Total Pb(g/Kg)124.730.035.211.050.4219.6216.720.926.611.430.3216.1318.022.025.911.160.3016.0412.615.820.610.610.3217.158.211.514.011.270.2716.06 6.610.012.611.360.4916.07 5.67.310.310.780.0621.48 5.68.812.010.690.0520.69 4.5 6.59.110.410.3817.31031.535.846.011.011.168.371121.126.334.211.412.1910.41219.325.032.611.190.499.11313.718.523.511.070.359.0149.412.816.111.33 1.088.515 6.49.311.910.871.210.78168.310.514.610.850.2510.1117 5.37.410.011.25 1.2710.76182.93.9 5.610.89 1.110.821922.326.032.810.910.758.872018.625.430.310.961.168.02115.318.227.411.23 1.097.6228.113.419.610.220.277.623 6.210.913.810.60.948.6824 4.88.915.510.570.447.5250.07.29.58.042.419.67260.0 4.37.69.68 1.369.99270.0 2.5 5.49.79 1.189.172828.433.338.0110.834.192922.331.340.911.150.16 4.43015.019.826.410.980.765.23113.816.728.211.460.95 5.03212.015.923.810.40.63 5.513311.712.218.59.750.58 4.19347.413.117.07.33 6.14 6.30357.710.516.38.86 1.436.2436 3.8 6.87.9 6.4133 5.513719.623.825.910.290.227.943816.717.921.810.40.328.93911.212.013.310.540.3711.14026.428.730.2 5.7891.94.7Fig.5.TCLP pH value and Pb content of concrete mixes studied.J.Hu et al./Construction and Building Materials xxx (2012)xxx–xxx5Abram’s Law.Then,the a/c ratio (a/c 1,2,3)can be evaluated through Lyse’s Law based on the w/c and required workability (slump)le-vel.Finally,the cement content (C 1,2,3)can be determined based on the Molinari’s Law from a/c.The concrete mix design is there-fore determined based on these three parameters:w/c,a/c,and C.In order to comply a set of mix design nomograph,a series of mixes with different proportion components (w/c,a/c and C)gen-erally need to be prepared based on controlled workability.The6J.Hu et al./Construction and Building Materials xxx (2012)xxx–xxxperformance (such as compressive strength)of these mixtures are then evaluated and incorporated into the nomograph so as to establish the relation between mix proportion parameters (w/c,a/c and C).Fig.8provides four examples of nomographs of concrete made with different masonry materials and different types of cement.In these nomographs,compressive strength at three different ages (3,7,and 28days)was considered as the concrete performance crite-ria in addition to workability.These nomographs demonstrate sim-ilar trends to those published in the literature [14].Similar nomographs can also be developed if other performance test re-sults,such as ?exural strength,are used to replace concrete strength values in the ?gure.Thus,concrete can be designed to meet the other performance criteria.More nomographs resulting from the present study can be found in the reference reported by Wang et al.[8].The mix design nomographs developed in this study can help ?eld engineers select the proper mix proportion parameters to meet speci?ed concrete performance criteria.Concretes with desir-able compressive strengths and workability levels can be designed using LBP-contaminated recycled aggregates.While these con-cretes might have high concentrations of total lead (up to 2.2%in this study),they would not have a toxicity characteristic for lead and would not be classi?ed as hazardous materials under RCRA.J.Hu et al./Construction and Building Materials xxx (2012)xxx–xxx 75.ConclusionsA variety of concrete mixes was made with four different aggre-gates recycled from lead-contaminated masonry materials,three different kinds of cement,three different aggregate-to-cement ra-tios,and a wide range of water-to-cement ratios.The concrete workability,compressive strength,total lead and lead leachability of the concrete mixes were evaluated.Based on the test results,mix design nomographs were developed.The following conclu-sions can be made: 1.Lead in the LBP-contaminated masonry materials can be sequestered in concrete due to the high alkalinity of cement.Although some masonry materials were classi?ed as hazard materials due to leachable lead content,concrete mixes made with such materials showed no toxicity characteristic for lead according to the Resource Conservation and Recovery Act (RCRA).2.Although having low speci?c gravity and high absorption,crushed masonry materials,without sieving and re-grading process,can be simply used to replace all natural aggregate8J.Hu et al./Construction and Building Materials xxx (2012)xxx–xxxand to produce new concrete that meets structural and con-structability requirements.3.Using of Calcium Sulfoaluminate (CSA)cement signi?cantly increased concrete strength at early ages but had a little effect on the 28-day compressive strength.The CSA cement was less alkaline than Portland cement,and the concrete made with CSA cement had lower pH values than the corresponding con-crete made with Portland cement,thus being less effective for sequestering lead in the concrete.4.Theoretically,phosphate cold react with lead to form hydrox-ypyromorphite,thus resulting in sequestration of lead.How-ever,such a reaction did not occur in the present study and the addition of 5%phosphate had no signi?cant effect on appar-ent total lead content,lead leachability,or compressive strength.5.When well designed and well processed,the concrete made with all recycled aggregate from deconstructed masonry mate-rials can have a large range of workability and strength,thus applicable to various new concrete constructions,such as foun-dation and pavement,reinforcedbeams,columns,and walls.6.The mix design nomograph developed in this study can be used to decide concrete mix design with desired strengths and work-ability.This method can be easily adapted by ?eld engineers for designing concrete with aggregates recycled from different ?eld deconstruction projects. AcknowledgementsThe authors gratefully acknowledge the Strategic Environmen-tal Research and Development Program (SERDP)for sponsor the re-search project and the support provided by the National Concrete Pavement Technology Center (CP Tech Center).Special thanks are given to Mr.Robert Steffes,Dr.David White,Dr.Zhi Ge,and Mr.Eric Lindquist for their assistance in the lab and Mr.John Lathum at the Department of Environmental Health and Safety,Iowa StateUniversity for providing advice and assistance in dealing with occupational safety and hazardous waste issues associated with this project.Mr.Row Carr and Mr.Steve Otto at the Holcim Ltd.kindly provided donations of masonry materials and cement.References[1]ESTCP (Environmental Security Technology Certi?cation Program).ThermalSpray Removal of Lead-Containing Paint of Steel Structures,US Department of Defense,Cost and Performance Report (CP-9607);1999.[2]Hock VF,Edwards-Daniels A.Field demonstration of lead-based paint removaland inorganic stabilization technologies.Environmental Quality Management Inc.;2001.[3]Jacobs DE,Mielke H,Pavur N.The high cost of improper removal of lead-basedpaint from housing:a case report.Environmental Health Perspectives;2003.p.111.[4]Garrels RM,Christ CK,Solutions,minerals,and equilibria.Harper and Row;1965.[5]Brookins DG.Eh–pH diagrams for geochemistry.Springer-Verlag;1988.[6]Cao X,Ma LQ,Chen M,Hardison DW,Harris WG.Weathering of lead bulletsand their environmental effects at outdoor shooting ranges.J Environ Quality 2003;32:526–634.[7]ASTM (American Society for Testing and Materials).Annual Book of ASTMStandards;2010.[8]Wang K,Gaunt JA,Hu J.Sequestering lead in paint by utilizing deconstructedmasonry materials as recycled aggregate in concrete,Strategic Environmental Research and Development Program (SERDP)Project SI 1548;2008.[9]US EPA.Method 1311Toxicity Characteristic Leaching Procedure,CD-ROM,Revision 0;1992.[10]California Code of Regulations.California State of Waste Extraction Test (WET)procedures.California Code of Regulations,Title 22,Division 4.5,Chapter 11,Appendix II;2005.[11]Kosmatka SH,Kerkhoff B,Panarese WC.Design and control of concretemixture.14th ed.Portland Cement Association;2002.[12]Neville AM.Properties of concrete.4th ed.ELBS and Longman;1996.[13]Hu J,Wang K,Gaunt JA.Sequestering lead by utilizing lead based paintcontaminated masonry materials as recycled aggregate in concrete.Resour,Conserv Recy 2010;54(12):1453–60.[14]Levy SM,Helen P.Durability of recycled aggregates concrete:a safe way tosustainable development.Cem Concr Res 2004;34:1975–80.[15]Monteiro PJM,Helene PRL,Kang SH.Designing concrete mixtures for strength,elastic modulus and fracture energy.Mater Struct/Materiaux et Construc 1993;26:443–52.J.Hu et al./Construction and Building Materials xxx (2012)xxx–xxx9。

1、麦肯锡全球最著名的管理咨询公司之一，1926年在美国成立，是专门为企业高层管理人员服务的国际性公司，在全球44个国家和地区开设了84个分公司，目前拥有9000多名咨询人员，分别来自78个国家，均具有世界著名学府的高等学位。

其业务主要是提供战略方面的咨询，同时还涉足企业金融、商业技术和运营等一系列广泛的咨询领域及管理议题。

麦肯锡中国公司被评为"中国最受尊敬企业"之一。

2、罗兰.贝格罗兰·贝格国际管理咨询公司于1967年在德国建立，现已成为欧洲最大的管理咨询公司之一，隶属于德意志银行集团，在全球26个国家和地区设有35个办事处。

公司的咨询顾问来自全球近四十个国家。

专长于为企业提供公司战略、重建、重组、市场营销、物流营运、企业兼并后联合及人力资源管理等咨询服务，帮助您解决在市场进入战略确定、中国营运模式的建立、合资企业重建与购并、全国销售网络控制及招聘与保留人才方面的问题。

3、埃森哲全球领先的管理及信息技术咨询机构，2003财政年度纯收入达118亿美元。

拥有83,000多名员工，在全球47个国家和地区设有110多家分支机构。

为各行各业的客户提供广博精深的专业服务和业务解决方案。

在公司战略目标的指导下，为了全方位地满足客户的需求，正在不断拓展业务服务网络，包括管理咨询、信息技术、经营外包、企业联盟和风险投资。

4、毕博毕博（BearingPoint）—原毕马威管理咨询（KPMG Consulting），总部位于美国弗吉尼亚州麦克林市，是世界最大的管理咨询公司和系统集成商之一，拥有员工16000余人，年收入近29亿美元,服务全球2100多家企业客户，其中包括72家美国《财富》100强公司、318家《财富》1000强公司以及超过四分之一的环球《财富》2000强公司,并致力于服务中小型企业、政府机构和其它组织，是美国26家政府部门中21家的主要系统集成服务提供商。

毕博（BearingPoint）有着极高的客户合作保持率，其中前150位的保持率为96％，而前50位大客户的保持率更是高达100％。

S H I F T T O S A F E T Y安全/传感/控制2022产品手册Products and ServicesS h e n z h e n T o r e n t T e c h n o l o g y C o.,L t d.深圳市多恩技术有限公司0755********1. 功能安全控制器及传感器，产品最高可达PLe/SiL3安全性能等级，符合中国及全球标准，通过欧美专业机构和中国国家检测中心认证，应用于自动化设备，AGV，物流系统，数控机床，电梯，机器人，风电等诸多行业；2. 提供专业的自动化产线整体安全防护系统风险评估，设计与定制。

一站式交钥匙工程，最高符合PLe/SiL3安全性能等级，快速实现安全智能连接。

多恩技术是专业的安全传感控制研发企业，具备TUV 认证的机械安全风险评估资质，同时也是中国机械工业安全卫生协会会员单位，公司产品具有多项发明及实用新型专利，并获得多家国内国际权威机构认证。

Profile公司简介产品与服务P&S技术与荣誉Honor多恩技术是专注于工业安全控制与传感技术的研发型企业，由曾任职于世界100强工业电气巨头的海归工程师团队创建，具备电子、电气、机械核心研发能力，团队70%以上为十年以上工业行业经验的研发人员。

我们 的目标是让产品功能及应用精益求精，解决工业生产的安全难题，把安全的基因更加广泛植入到国内的传感与控制系统中，推动工业4.0的战略早日实现。

引言CONENT 目录0102040607081012141516171820多功能安全继电器功能型安全继电器可配置安全继电器佰安翼AnEZ 电磁式安全联锁开关截留钥匙型安全开关门栓把手部件安全触边/地毯安全围栏安全控制系统Safety V+可视化监视系统安全评估与改造行业应用引言01切割事故会造成严重的后果，比如人员伤亡，设备受损，生产停滞，经济赔偿，行政处罚，法务支出，额外的事故处理人力及费用，企业名誉受损等。

广州富盛音响体验中心开幕●女本W记者／摄影张国棵继W i s dom A udi o宣布推出新系列入墙式喇叭系统后．近日本刊记者应邀出席了在广州举行的W i s dom A udi o平面电磁振膜扬声系统的新闻发布会．井有幸鉴赏和聆听了音响效果。

美国W i s dom A ud i o的总经理M ark G l az i er先生及技术营销总监Jon H e r r en先生亲临现场．讲解了平面电磁振膜扬声器的技术研发过程。

介绍中获悉．W i sdom A udi o公司于1996年创立．是一家专门从事H i E nd级家庭影院及H i Fi系统开发与生产的厂家一W i s dom A udi o公司能够在相对较短的时间内得到世界各地影音媒体的认可．很大程度上离不开它背后的团队。

而且这个团队中的每一个成员在过去都曾在著名的H i E nd音口自及家庭影院设计与生产厂家中任过职．拥有丰富的研发、生产以及销售经验。

因此，W i sdom A udi o可以称得上是由一帮“技术狂^”打造而成的超级H i E nd家庭影院及H i—Fi音响厂商一其目W i sdom A i J d{oi l#然{黢‘W i s dom A udi o是设计和制造高性能平面电磁振膜的专家．拥有超过90年扬声器制造经验。

为广大严苛的发烧友研究出毫不妥协的平面电磁振膜扬声器。

W i s dom A udi o系统栗用专利的平面电磁技术和电动式单元，带来最出色的声音效果。

这种混台技术系统已获得多个由专业媒体颁发的奖项．同时还满足了规模日益庞大的全球顾客与经销商的需求。

屡获殊荣的W i s dom A udi o Sage系列扬声器，由专业工匠在公司总部内华达州卡森市纯手工限量打造．今天亮相中国市场，以满足日益壮大的中国音响市场需求。

由于现时多声道家庭影院音响是影音市场的主流．而对于某部分高端消费用户来说，他们通常都对声音品质和房间美学有着极高的要求．所以人墙式音箱是最好的解抉方案。

A GUIDE FOR NEW FACILITIES VOLUME 5: COMMISSIONING AND QUALIFICATIONEXECUTIVE SUMMARYJUNE 2000A DOCUMENT DEVELOPED IN PARTNERSHIP BY:23ISPE PHARMACEUTICAL ENGINEERING GUIDECOMMISSIONING AND QUALIFICATIONFOREWORDAs noted in the Baseline® Guides, Volume 1, the pharmaceutical industry has experienced a ratcheting effect in the cost of new facilities. This increase in cost has been driven in part by uncertainty about the requirements for regulatory compliance. Some significant areas of concern are validation, particularly related to automation systems, and the trend to validate back to source utilities, architectural and HVAC. The absence of a consistent and widely accepted interpretation of regulatory requirements has led to one-upmanship. This practice of building increasingly technically advanced facilities has led to increased cost, longer lead times and, in some cases, delays in bringing new products to market.In May 1994, engineering representatives from the pharmaceutical industry engaged in a discussion with the International Society for Pharmaceutical Engineering (ISPE) and the Food and Drug Administration (FDA). That first discussion allowed for the creation of 10 facility engineering guides, now known as the Baseline® Pharmaceutical Engineering Guides. These guides are intended to assist pharmaceutical manufacturers in the design, construction and commissioning of facilities that comply with the requirements of the FDA. Volume 1, covering Bulk Pharmaceutical Chemicals (BPC), was published in June of 1996. This Guide, for Commissioning and Qualification, is the fifth volume in the series.As with the BPC Guide, the Commissioning and Qualification Guide, has been sponsored by ISPE’s Pharmaceutical Advisory Council, made up of senior pharmaceutical engineering executives from owner companies, the FDA and ISPE senior management. Overall planning, direction and technical guidance in the preparation of the Commissioning and Qualification Guide was provided by a Steering Committee most of whom were involved in the BPC Guide. The Commissioning and Qualification Guide itself was produced by a task force of around 60 individuals who expended a great deal of their own time in its preparation and development.Editors’ Disclaimer:This guide is meant to assist pharmaceutical manufacturers in the design and construction of newfacilities that comply with the requirements of the Food and Drug Administration (FDA). TheInternational Society for Pharmaceutical Engineering (ISPE) cannot ensure, and does not warrant,that a facility built in accordance with this guide will be acceptable to FDA.4ISPE PHARMACEUTICAL ENGINEERING GUIDECOMMISIONING AND QUALIFICATIONACKNOWLEDGEMENTSThis guide was developed by an integrated US-European team under the co-leadership of Alan Philips of Pfizer and Christopher Wood of Glaxo Wellcome.The Core Team on the guide was comprised:Alan Philips PfizerChristopher Wood Glaxo WellcomeBob Myers KvaernerGeorgia Keresty, Ph.D. Bristol Myers SquibbThe Extended Review Team was comprised the Core Team plusJan Gustafsson Novo NordiskGraham Shewell SmithKline BeechamTodd Troutman KvaernerSimon Shelley Glaxo WellcomeGene Yuan Hoffman LaRocheThe Chapter Credits are as follows:Introduction Alan PhilipsGeorgia Keresty, Ph.D. PfizerBristol-Myers SquibbKey Concepts & Philosophy Chris WoodGeorgia Keresty, Ph.D. Glaxo Wellcome Bristol-Myers SquibbImpact Assessment Bob MyersSimon ShelleyTodd Troutman KvaernerGlaxo WellcomeKvaerner5Good Engineering Practice John FadoolGraham Shewell Glaxo Wellcome SmithKline BeechamCommissioning Mark E. Miller1Chris WoodGraham Shewell GenentechGlaxo Wellcome SmithKline BeechamQualification Practices Jan GustafssonGene YuanSue Bacso Novo Nordisk Hoffman LaRoche MerckEnhanced Design Review Graham ShewellChris Wood SmithKline Beecham Glaxo WellcomeInstallation Qualification Bob MyersBob AdamsonTodd Troutman Kvaerner Foster Wheeler KvaernerOperational Qualification Bob MyersTodd Troutman Kvaerner KvaernerPerformance Qualification Chris Dell Cioppia KvaernerRelated Programs Georgia Keresty, Ph.D.Todd Troutman Bristol-Myers Squibb KvaernerIllustrative Examples Bob Myers KvaernerThe guide co-team leaders would also like to acknowledge the contributions made by the following part-time members of the guide team:Flemming Steen Jensen (then of) Novo NordiskSteve Heidel MerckCecilia Luna Novartis1 With the support of John Hughes (TVS Inc,), Jon Sheh (Alza Inc.) and Gary Schoenhouse (Genentech)6Tony deClaire APDC ConsultingFDA Reviewers:We would like to thank the following FDA review team for their input to this guide:Robert Sharpnack InvestigatorEric S. Weilage NDA/ANDA Pre-approval Inspection ManagerRobert Coleman National Drug Expert, DEIOBrian Nadel Compliance Officer, CDERWe also appreciate FDA support from the following representatives:Sharon Smith-Holston Deputy Commissioner for External AffairsSusan Setterberg Regional Director, Mid-Atlantic RegionJoe Phillips Deputy Regional Manager, Mid-Atlantic RegionIn addition, we would like to acknowledge the support and contribution of the ISPE Technical Documents Steering Committee, in particular the following members:Paul D’Eramo Committee Chairman, Johnson & JohnsonMel Crichton Eli LillyBruce Davis Astra ZenecaPaul Lorenzo (Retired)71. INTRODUCTION1.1 BACKGROUNDThe design, construction, commissioning and qualification of manufacturing facilities regulated by FDA or other regulatory authorities pose significant challenges to manufacturers, engineering professionals and equipment suppliers. These facilities are required to meet cGMP regulations while remaining in compliance with all other governing codes, laws, and regulations.The cost and time required to bring such facilities on line has been increasing, in many cases due to inconsistent interpretation of regulatory requirements. The ISPE and engineering representatives from a broad base of healthcare companies (e.g. pharmaceutical, device, biotechnology, etc.) have entered into a partnership with the Food and Drug Administration (FDA) to enhance understanding of Baseline cGMP requirements for facilities. This Guide is intended to define key terms and offer a consistent interpretation, while still allowing a flexible and innovative approach to facility design, construction, commissioning and qualification. A fundamental goal of the Guide is to provide value added guidance to industry that will facilitate timely and cost effective commissioning and qualification of facilities.This guide is one in a series of Baseline® Guides being planned and produced by ISPE. The majority of these are specific to one functional area (e.g. Oral Solid Dosage Forms). However, this guide provides advice and guidance that may be applied to all types of facilities, utilities and equipment found in the healthcare industry.This Guide was prepared by the ISPE, and has incorporated comments from:Industry representatives from all areas and disciplinesFDA Field Investigators and personnel from The Center for Drug Evaluation and ResearchIt is recognized that industry standards evolve and this document reflects the understanding of these standards, as of publication date.1.2 SCOPE OF THIS GUIDEThis is a Guide to be used by industry for the design, construction, commissioning and qualification of new or newly renovated manufacturing facilities that are regulated by FDA or other health authorities. It is neither a standard nor a GMP. It is not intended to replace governing laws, codes, standards or regulations that apply to facilities of this type. These are mentioned only for completeness and where their impact affects facility, equipment and utility design relative to cGMP’s. The use of this document for new or existing facilities, equipment or utilities is at the discretion of the owner or operator.This Guide focuses on the engineering approaches and practices involved in providing cost effective manufacturing facilities in a timely manner that meet their intended purposes. Specifically, the Guide addresses the process of designing, constructing, commissioning and qualifying the facilities, utilities and equipment regulated by FDA or other health authorities.This Guide is not intended to address any aspect of process/product validation. This is a subject that has been well defined by FDA and other authorities and for which substantial guidance documentation exists.It must be recognized, however, that Commissioning and Qualification activities are the foundation upon which Process Validation is built. Furthermore, these activities play a crucial role in delivering operationally effective, safe and efficient facilities, utilities and equipment. Therefore, it is important to ensure that a comprehensive approach is 8undertaken during the commissioning and qualification process. A well conceived and executed commissioning and qualification plan can greatly facilitate a timely and cost effective validation effort.Where non-engineering issues are covered (e.g. support systems, documentation, decision processes), the guidance is provided to show engineers the importance of such topics and the impact they have on the commissioning and qualification process. Consequently, non-engineering topics are not covered comprehensively. Specialist advice from QA Departments should be sought where additional information is required.The Guide is intended primarily for facilities, equipment and utilities meeting regulatory requirements to supply the United States (US) market and is aligned with US standards and references. The Guide may also be helpful to manufacturers needing to meet European requirements.91.3 KEY FEATURES AND CHAPTERS OF THIS GUIDEThe following key concepts are defined and used as a basis for guidance:• Direct Impact Systems• Indirect Impact Systems• System Impact Assessment• Good Engineering Practice• Commissioning• Qualification Practices• Enhanced Design Review• Installation Qualification• Operational Qualification• Performance Qualification• Consistent Terminology• Documentation RequirementsSOME BRIEF EXPLANATION OF THESE IS AS FOLLOWS:It is the function of the facility, equipment or utility that determines what level of commissioning and qualification are needed.• ‘Direct Impact’ systems are expected to have an impact on product quality• ‘Indirect Impact’ systems are not expected to have an impact on product qualityBoth types of systems will require commissioning, however, the “Direct Impact” systems will be subject to supplementary qualification practices to meet the additional regulatory requirements of the FDA and other regulatory authorities.The determination of a system as either ‘Direct Impact’ or ‘Indirect Impact’ is critical. It is this differentiation between system types that determines the degree of effort and level of resources required for each system. System Impact Assessment provides the thought process and some key questions that must be asked in making the determination.During the production of this guide, regulatory authorities have expressed concern that designating a system “Indirect Impact” might be a means of doing less than full testing on a system that may actually require it. This is not the intention. The objective is that through a comprehensive impact assessment process, those systems presenting a risk to product quality are identified and given the attention appropriate to this level of risk, and by the right people (e.g. QA Departments).For this process to work it is essential that an explicit rationale is provided for the indirect/direct impact assessment and that the rationales are fully understood, documented and endorsed by QA Departments. This places a responsibility upon engineers to communicate clearly the nature of operation of engineering systems, and their potential impact on product quality.It will also be seen that throughout the Guide, the application of Good Engineering Practice is essential to the commissioning and qualification activities. Good Engineering Practice, commonly referred to as GEP, is proven and accepted, cost-effective, engineering methods and practices that ensure the effective satisfaction of stakeholder requirements. As such, GEP ensures that an engineering project meets the requirements of the user while being cost effective, compliant with regulations and well documented. Guidance and standards that have been defined by engineering institutes and other learned bodies support GEP. For direct impact systems, GEP is supplemented by enhanced documentation and qualification practices with the active participation of Quality Assurance personnel.The guide also attempts to clarify some misconceptions about how activities are defined, which activities are the subject of regulatory oversight and the sequence, if any, of these activities. For example, the guide discusses “Enhanced Design Review” and the components and criteria of this activity. The intent is to identify design aspects that are key to manufacturing facilities regulated by the FDA or other health authorities. How this enhanced design review is accomplished, either with a formal or informal process, is at the discretion of the individual company. The intent is not to establish new administrative requirements, especially for those activities not regulated by FDA or other regulatory authorities. The design review activities are part of GEP and are unregulated by FDA, i.e. these are good engineering practices, not regulatory requirements.Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are activities that FDA may have an interest in, since these are the final activities before process validation can begin. IQ/OQ in many instances is done concurrently with commissioning and requires the enhanced documentation, QA involvement and additional tests and checks known as Qualification Practices.An overview of the Chapter structure is given in Figure 1-2.Figure 1-2: Chapter Structure1.4 GOALS OF THIS GUIDEThere are two primary goals of the Commissioning and Qualification Baseline® Guide. The first is to bring a common terminology and methodology to the commissioning and qualification process that can be used by manufacturers, facility designers, contractors and equipment suppliers. The second is to provide a system impact assessment process to bring structure and consistency to determining a direct and indirect impact system. An important secondary goal is to foster an interdisciplinary team approach to commissioning and qualification. Such an approach will help establish an effective basis for master planning and execution of facility projects. Specifically, the Guide is focused upon value added approaches that will eliminate duplication of effort and the costly practices of:• Repeating qualification steps during process validation• Qualifying systems that only require commissioning• Generating insufficient or excessive documentation• Excessively long project schedules• Delays which can result in product supply interruptions or delayed product launches2. GUIDE PHILOSOPHY AND KEY CONCEPTSThis Chapter describes the purpose and philosophy of the Commissioning and Qualification Baseline® Guide, and the differences between the commissioning and qualification processes in the context of this Guide. It is important to understand and apply the approaches outlined in this Baseline® Guide in a sound and well-reasoned manner, since every facility and project is different.The key terms used in the Guide are defined, including:• Direct Impact System• Indirect Impact System• No Impact System• Design for Impact• Good Engineering Practice• Enhanced Design Review• CommissioningAn overview of Qualification Practices is given, including Enhanced Design Review, Installation Qualification, Operational Qualification, and Performance Qualification. V-models are provided for both Direct Impact systems and Indirect Impact systems and the role of Quality Assurance is discussed.3. IMPACT ASSESSMENTImpact Assessment is the process of determining which systems and/or system components should be subject to Qualification Practices in addition to Good Engineering Practices (GEP). Impact Assessment assists in defining the Commissioning and Qualification scope of a project.This Chapter considers the Impact Assessment process. Terms specific to Impact Assessment are defined. A method is suggested for defining the steps of a system assessment process, including a discussion of the benefits, and a list of the criteria for determining system impact and component criticality.4. GOOD ENGINEERING PRACTICEThis Chapter provides an overview of the various project phases and sequence, from inception through commissioning, qualification, and operation. Concepts associated with “Good Engineering Practice” (GEP), the types of activities that occur, and documentation that is created through GEP are discussed. Overviews are provided of both effective project controls, and project team concepts and organization.The Requirements phase is considered in detail, including:• Project Purpose and Justification• User Requirements Brief• Requirements Specifications• Project Execution Plan• Maintenance and Technical Support Requirements• Compliance Requirements• DeliverablesStages in the design process are described with specific consideration of Piping and Instrumentation Diagrams, Specifications, and Construction drawings. Construction involves several elements, which are crucial to every project, including project site logistics and project quality control. This Chapter details typical requirements and elements of construction.The information given in the Chapter aims to demonstrate how GEP, as applied throughout the project lifecycle, provides a basis for effective qualification.5. COMMISSIONINGThis Chapter defines the term “commissioning” in the context of the Guide and describes the organization and content of the Commissioning Plan document. Commissioning is positioned within the context of the Qualification effort and guidance is provided in the management and execution of the commissioning activities. Typical commissioning deliverables and the associated commissioning team responsibilities are considered.Commissioning activities described include:• Inspection• Setting-to-Work• Regulation and Adjustment• Testing and Performance Testing• Training• Turnover• Commissioning Plan Close-Out6. QUALIFICATION PRACTICESDirect impact systems are subject to qualification practices that incorporate the enhanced review, control and testing against specifications and requirements necessary for compliance with current Good Manufacturing Practice. The purpose of this chapter is to introduce a high level overview of qualification practices that are required for direct impact systems. The Validation Master Plan and Qualification Rationale are described in detail. This Chapter contains detailed consideration of Enhanced Documentation.7. ENHANCED DESIGN REVIEWEnhanced Design Review (EDR) is the term adopted by this guide to describe the process by which engineering designs for pharmaceutical facilities, systems and equipment are evaluated. This process compliments Good Engineering Practice.This Chapter gives the regulatory perspective on EDR and relates EDR to the V-Model for Direct Impact systems. The EDR process is detailed. A structured design review method and a failure modes analysis method are suggested for evaluating designs.8. INSTALLATION QUALIFICATIONInstallation Qualification (IQ) is an activity that is regulated by the FDA, and is a part of final qualification activities before process validation begins.The primary objectives of this chapter are to:• Provide an overview of the Installation Qualification process• Describe the types of activities that occur and documentation that is needed for the Installation Qualification Process• Describe how Installation Qualification fits in with the overall qualification process• Describe how Commissioning integrates within the Installation Qualification process9. OPERATIONAL QUALIFICATIONOperational Qualification (OQ) is an activity that is regulated by the FDA, and is a part of final qualification activities before Performance Qualification or Process Validation begins.The primary objectives of this chapter are to:• Provide an overview of the Operational Qualification process• Describe the types of activities that occur and documentation that is needed for the Operational Qualification Process• Describe how Operational Qualification fits in with the overall qualification process• Describe how the commissioning process integrates within Operational Qualification10. PERFORMANCE QUALIFICATIONPerformance Qualification (PQ) is an activity that is regulated by the FDA, and is the final qualification activity before the remainder of Process Validation begins. For pharmaceutical grade utilities and certain support systems, PQ is the final qualification step.Once the system (or systems) have gone through IQ and OQ execution and have been approved/accepted the PQ can be performed.The primary objectives of this chapter are to:• Provide an overview of the Performance Qualification process• Describe the types of activities that occur and documentation that is needed for the Performance Qualification Process• Describe how Performance Qualification fits in with the overall qualification process• Describe how the commissioning process integrates within Performance Qualification11. RELATED PROGRAMSThis Chapter provides details of those programs that are undertaken to provide assistance and information in support of the qualification activities. Some of these programs can be applied to ‘Direct’, ‘Indirect’ and ‘No Impact’ systems and their components. Where these programs are undertaken in support of qualification activities, the appropriate qualification practices must be followed to ensure that the compliance of the over-all qualification effort is not compromised. Related programs considered include:• Safety• Standard Operating Procedures• Training• Preventative Maintenance and Calibration• Computer Systems Validation• Cleaning Validation• Analytical Method Validation• Process Validation• Revalidation12. GLOSSARYTerms and concepts used throughout the Commissioning and Qualification Baseline® Guide are defined and cross-referenced.13. ILLUSTRATIVE EXAMPLESThe illustrative examples given in this Chapter provide one interpretation of how the key concepts of this guidecan be applied in preparing for commissioning and qualification activities. Depending upon company policies or the intended use of the equipment listed, there may be additions or deletions to the listed activities. APPENDIXThe Appendix provides detail and references for Failures Modes Analysis.。