ASTM D3764-2015e1 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems《过程流量分析仪系统性能确认的标准实施规程》.pdf

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1、Designation: D3764 151Standard Practice forValidation of the Performance of Process Stream AnalyzerSystems1This standard is issued under the fixed designation D3764; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEEditorial changes made throughout in July 2015.INTRODUCTIONOperation of a process stream analyzer system typically involves four s

3、equential activities.(1) Analyzer Calibration When an analyzer is initially installed, or after major maintenance hasbeen performed, diagnostic testing is performed to demonstrate that the analyzer meets themanufacturers specifications and historical performance standards.These diagnostic tests may

4、requirethat the analyzer be adjusted so as to provide predetermined output levels for certain referencematerials. (2a) Correlation for the Same MaterialOnce the diagnostic testing is completed,process stream samples are analyzed using the analyzer system. For application where the processanalyzer sy

5、stem results are required to agree with results produced from an independent (primary) testmethod (PTM), a mathematical function is derived that relates the analyzer results to the primary testmethod results (PTMR). The application of this mathematical function to an analyzer result producesa predic

6、ted primary test method result (PPTMR), for the same material. (2b) Correlation forMaterial including Effect from Additional Treatment to the MaterialThe PPTMR in (2a) can beused as an input to a mathematical model to predict the effect of an additive and/or a blendstock addedto a basestock material

7、 as measured by a PTM. (3) Probationary ValidationAfter the correlation(s)relationship between the analyzer results and primary test method results has been established, aprobationary validation is performed using an independent but limited set of materials that were notpart of the correlation activ

8、ity. This probationary validation is intended to demonstrate that thePPTMRs agree with the PTMRs to within user-specified requirements for the analyzer systemapplication. (4) General and Continual ValidationAfter an adequate amount of PPTMRs andPTMRs have been accrued on materials that were not part

9、 of the correlation activity, a comprehensivestatistical assessment is performed to demonstrate that the PPTMRs agree with the PTMRs to withinthe tolerances established from the correlation activities. Subsequent to a successful generalvalidation, quality assurance control chart monitoring of the di

10、fferences between PPTMR and PTMRis conducted during normal operation of the process analyzer system to demonstrate that theagreement between the PPTMRs and PTMRs established in the General Validation is maintained. Thispractice deals with the third and fourth of these activities.“Correlation for mat

11、erial including effect from additional treatment to the material” as outlined inthis standard is intended primarily to be applied to biofuels where the biofuel material is added at aterminal or other facility and not included in the process stream material sampled by the analyzer atthe basestock man

12、ufacturing facility. The correlation shall be specific for a constant percentageaddition of the biofuels material to the basestock for each model. This practice may not apply forphysical properties where the source material for the biofuel material or the denaturant/diluentmaterial used with the bio

13、fuel material can significantly affect the finished biofuels physical property.The user of the standard should investigate the effect of changes to biofuels material blend ratios,biofuels material source material, and blendstock material composition when using this practice.Limits to any of these ma

14、y need to be applied when the correlation is used.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States11. Scope*1.1 This practice describes procedures and methodologiesbased on the statistical principles of Practice D6708 to validatewhethe

15、r the degree of agreement between the results producedby a total analyzer system (or its subsystem), versus the resultsproduced by an independent test method that purports tomeasure the same property, meets user-specified requirements.This is a performance-based validation, to be conducted usinga se

16、t of materials that are not used a priori in the developmentof any correlation between the two measurement systems underinvestigation. A result from the independent test method isherein referred to as a Primary Test Method Result (PTMR).1.1.1 The degree of agreement described in 1.1 can be eitherfor

17、 the same materials, or, for materials including effect fromadditional treatment to the basestock material.NOTE 1Subsection 1.1.1 refers to the application where PPTMR forthe same material can be used as an input to a mathematical model topredict the effect of an additive added to the basestock mate

18、rial as by aPTM.1.2 This practice assumes any correlation necessary tomitigate systemic biases between the analyzer system and PTMhave been applied to the analyzer results. See Guide D7235 forprocedures for establishing such correlations.1.3 This practice assumes any modeling techniques em-ployed ha

19、ve the necessary tuning to mitigate systemic biasesbetween the analyzer PPTMR and PTMR have been applied tothe model results. Model form and tuning is not covered by thispractice, only the validation of the model output.1.4 This practice requires that both the primary methodagainst which the analyze

20、r is compared to, and the analyzersystem under investigation, are in statistical control. Practicesdescribed in Practice D6299 should be used to ensure thiscondition is met.1.5 This practice applies if the process stream analyzersystem and the primary test method are based on the samemeasurement pri

21、nciple(s), or, if the process stream analyzersystem uses a direct and well-understood measurement prin-ciple that is similar to the measurement principle of the primarytest method. This practice also applies if the process streamanalyzer system uses a different measurement technology fromthe primary

22、 test method, provided that the calibration protocolfor the direct output of the analyzer does not require use of thePTMRs (see Case 1 in Note 2).1.6 This practice does not apply if the process streamanalyzer system utilizes an indirect or mathematically modeledmeasurement principle such as chemomet

23、ric or multivariateanalysis techniques where PTMRs are required for the chemo-metric or multivariate model development. Users should referto Practice D6122 for detailed validation procedures for thesetypes of analyzer systems (see Case 2 in Note 2).NOTE 2For example, for the measurement of benzene i

24、n sparkignition fuels, comparison of a Mid-Infrared process analyzer systembased on Test Method D6277 to a Test Method D3606 gas chromatogra-phy primary test method would be considered Case 1, and this practicewould apply. For each sample, the Mid-Infrared spectrum is convertedinto a single analyzer

25、 result using methodology (Test Method D6277) thatis independent of the primary test method (Test Method D3606). However,when the same analyzer uses a multivariate model to correlate themeasured Mid-Infrared spectrum to Test Method D3606 reference valuesusing the methodology of Practice E1655, it is

26、 considered Case 2 andPractice D6122 applies. In this case 2 example, the direct output of theanalyzer is the spectrum, and the conversion of this multivariate output toan analyzer result require use of Practice D6122, hence it is notindependent of the primary test method.1.7 Performance Validation

27、is conducted by calculating theprecision and bias of the differences between results from theanalyzer system (or subsystem) after the application of anynecessary correlation, (such results are herein referred to asPredicted Primary Test Method Results (PPTMRs), versus thePTMRs for the same sample se

28、t. Results used in the calculationare for samples that are not used in the development of thecorrelation. The calculated precision and bias are statisticallycompared to user-specified requirements for the analyzersystem application.1.7.1 For analyzers used in product release or productquality certif

29、ication applications, the precision and bias re-quirement for the degree of agreement are typically based onthe site or published precision of the Primary Test Method.NOTE 3In most applications of this type, the PTM is the specification-cited test method.1.7.2 This practice does not describe procedu

30、res for estab-lishing precision and bias requirements for analyzer systemapplications. Such requirements must be based on the critical-ity of the results to the intended business application and oncontractual and regulatory requirements. The user must estab-lish precision and bias requirements prior

31、 to initiating thevalidation procedures described herein.1.8 Two procedures for validation are described: the linesample procedure and the validation reference material (VRM)injection procedure.1.9 Only the analyzer system or subsystem downstream ofthe VRM injection point or the line sample extracti

32、on point isbeing validated by this practice.1.10 The line sample procedure is limited to applicationswhere material can be safely withdrawn from the samplingpoint of the analyzer unit without significantly altering theproperty of interest.1.10.1 The line sample procedure is the primary option forwhe

33、n the validation is for (2b) materials including effect fromadditional treatment to the material.1.11 Validation information obtained in the application ofthis practice is applicable only to the type and property rangeof the materials used to perform the validation.1.12 Two types of validation are d

34、escribed: GeneralValidation, and Level Specific Validation. These are typicallyconducted at installation or after major maintenance once thesystem mechanical fitness-for-use has been established.1This practice is under the jurisdiction of ASTM Committee D02 on PetroleumProducts, Liquid Fuels, and Lu

35、bricants and is the direct responsibility of Subcom-mittee D02.25 on Performance Assessment and Validation of Process StreamAnalyzer Systems.Current edition approved April 1, 2015. Published May 2015. Originallyapproved in 1980. Last previous edition approved in 2013 as D3764 13. DOI:10.1520/D3764-1

36、5E01.D3764 15121.12.1 General Validation is based on the statistical prin-ciples and methodology of Practice D6708. In most cases,General Validation is preferred, but may not always be possibleif the variation in validation materials is insufficient. GeneralValidation will validate analyzer operatio

37、n over a wider oper-ating range than Level Specific Validation.1.12.2 When the variation in available validation materialsis insufficient to satisfy the requirements of Practice D6708,aLevel Specific Validation is done to validate analyzer operationover a limited range.1.12.3 The validation outcome

38、are considered valid onlywithin the range covered by the validation material Data fromseveral different Validations (general or level-specific) canpotentially be combined for use in a General Validation.1.13 Procedures for the continual validation of systemperformance are described. These procedures

39、 are typicallyapplied at a frequency commensurate with the criticality of theapplication.1.14 This practice does not address procedures for diagnos-ing causes of validation failure.1.15 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theres

40、ponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D1265 Practice for Sampling Liquefied Petroleum (LP)Gases, Manual MethodD3606 Test Method

41、for Determination of Benzene andToluene in Finished Motor and Aviation Gasoline by GasChromatographyD4057 Practice for Manual Sampling of Petroleum andPetroleum ProductsD4177 Practice for Automatic Sampling of Petroleum andPetroleum ProductsD5842 Practice for Sampling and Handling of Fuels forVolati

42、lity MeasurementD6122 Practice for Validation of the Performance of Multi-variate Online, At-Line, and Laboratory Infrared Spectro-photometer Based Analyzer SystemsD6277 Test Method for Determination of Benzene in Spark-Ignition Engine Fuels Using Mid Infrared SpectroscopyD6299 Practice for Applying

43、 Statistical Quality Assuranceand Control Charting Techniques to Evaluate AnalyticalMeasurement System PerformanceD6708 Practice for Statistical Assessment and Improvementof Expected Agreement Between Two Test Methods thatPurport to Measure the Same Property of a MaterialD7235 Guide for Establishing

44、 a Linear Correlation Relation-ship Between Analyzer and Primary Test Method ResultsUsing Relevant ASTM Standard PracticesD7278 Guide for Prediction ofAnalyzer Sample System LagTimesD7453 Practice for Sampling of Petroleum Products forAnalysis by Process Stream Analyzers and for ProcessStream Analyz

45、er System ValidationD7808 Practice for Determining the Site Precision of aProcess Stream Analyzer on Process Stream MaterialE456 Terminology Relating to Quality and StatisticsE1655 Practices for Infrared Multivariate QuantitativeAnalysisF307 Practice for Sampling Pressurized Gas for Gas Analy-sis3.

46、Terminology3.1 Definitions:3.1.1 accepted reference value (ARV), n a value thatserves as an agreed-upon reference for comparison, and whichis derived as: (1) a theoretical or established value, based onscientific principles, (2) an assigned or certified value, based onexperimental work of some natio

47、nal or internationalorganization, or (3) a consensus or certified value, based oncollaborative experimental work under the auspices of ascientific or engineering group. E4563.1.2 between-method reproducibility (RXY), na quantita-tive expression of the random error associated with thedifference betwe

48、en two results obtained by different operatorsusing different apparatus and applying the two methods X andY, respectively, each obtaining a single result on an identicaltest sample, when the methods have been assessed and anappropriate bias-correction has been applied in accordancewith this practice

49、; it is defined as the 95 % confidence limit forthe difference between two such single and independentresults. D67083.1.2.1 DiscussionWithin the context of this practice, RXYis interpreted to be the 95 % confidence limit for the predictiondeviation between any single Primary Test Method Result(PTMR) and the Predicted Primary Test Method Result(PPTMR) produced by the analyzer system that is deemedacceptable on the assumption that both the analyzer system andprimary test method are in statistical control, and that thecorrelation relationship applied to the analyzer res