ASTM D3764-2015 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践规程》.pdf

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1、Designation: D3764 13D3764 15Standard 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 o

2、f last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONOperation of a process stream analyzer system typically involves four sequential activities.(1) Analyzer Calibration

3、 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 requirethat the analyzer be adjusted so as to

4、 provide predetermined output levels for certain referencematerials. (2)(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 system results are required to agree with re

5、sults 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 predicted primary test method result (PPTMR). (P

6、PTMR), for the same material. (2b) Correlationfor Material including Effect from Additional Treatment to the MaterialThe PPTMR in (2a)can be used as an input to a mathematical model to predict the effect of an additive and/or a blendstock added to a base stock material as measured by a PTM. (3) Prob

7、ationary ValidationAfter thecorrelationcorrelation(s) relationship between the analyzer results and primary test method results hasbeen established, a probationary validation is performed using an independent but limited set ofmaterials that were not part of the correlation activity. This probationa

8、ry validation is intended todemonstrate that the PPTMRs agree with the PTMRs to within user-specified requirements for theanalyzer system application. (4) General and Continual ValidationAfter an adequate amount ofPPTMRs and PTMRs have been accrued on materials that were not part of the correlation

9、activity, acomprehensive statistical assessment is performed to demonstrate that the PPTMRs agree with thePTMRs to within the tolerances established from the correlation activities. Subsequent to a successfulgeneral validation, quality assurance control chart monitoring of the differences between PP

10、TMR andPTMR is 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 material including effe

11、ct 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 base stock manufacturing facility

12、. The correlation shall be specific for a constant percentageaddition of the biofuels material to the base stock 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 biofuel material can

13、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 blend stock material composition when using this practice;limits to any of these may need to be appl

14、ied when the correlation is used.1 This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products, Liquid Fuels, and Lubricants and is the direct responsibility of SubcommitteeD02.25 on Performance Assessment and Validation of Process Stream Analyzer Systems.Current edition appr

15、oved May 1, 2013April 1, 2015. Published June 2013May 2015. Originally approved in 1980. Last previous edition approved in 20092013 asD3764 09.D3764 13. DOI: 10.1520/D3764-13.10.1520/D3764-15.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indica

16、tion of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be con

17、sidered the official document.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 methodologies based on the statistical principles of Practice D6708 to validatewhether the degree of agr

18、eement between the results produced by a total analyzer system (or its subsystem), versus the resultsproduced by an independent test method that purports to measure the same property, meets user-specified requirements. This is aperformance-based validation, to be conducted using a set of materials t

19、hat are not used a priori in the development of anycorrelation between the two measurement systems under investigation.Aresult from the independent test method is herein referredto as a Primary Test Method Result (PTMR).1.1.1 The degree of agreement described in 1.1 can be either for the same materi

20、als, or, for materials including effect fromadditional treatment to the base stock material.NOTE 1Subsection 1.1.1 refers to the application where PPTMR for the same material can be used as an input to a mathematical model to predictthe effect of an additive added to the base stock material as by a

21、PTM.1.2 This practice assumes any correlation necessary to mitigate systemic biases between the analyzer system and PTM havebeen applied to the analyzer results. See Guide D7235 for procedures for establishing such correlations.1.3 This practice assumes any modeling techniques employed have the nece

22、ssary tuning to mitigate systemic biases betweenthe analyzer PPTMR and PTMR have been applied to the model results. Model form and tuning is not covered by this practice,only the validation of the model output.1.4 This practice requires that both the primary method against which the analyzer is comp

23、ared to, and the analyzer systemunder investigation, are in statistical control. Practices described in Practice D6299 should be used to ensure this condition is met.1.5 This practice applies if the process stream analyzer system and the primary test method are based on the same measurementprinciple

24、(s), or, if the process stream analyzer system uses a direct and well-understood measurement principle that is similar tothe measurement principle of the primary test method. This practice also applies if the process stream analyzer system uses adifferent measurement technology from the primary test

25、 method, provided that the calibration protocol for the direct output of theanalyzer does not require use of the PTMRs (see Case 1 in Note 12).1.6 This practice does not apply if the process stream analyzer system utilizes an indirect or mathematically modeledmeasurement principle such as chemometri

26、c or multivariate analysis techniques where PTMRs are required for the chemometricor multivariate model development. Users should refer to Practice D6122 for detailed validation procedures for these types ofanalyzer systems (see Case 2 in Note 12).NOTE 2For example, for the measurement of benzene in

27、 spark ignition fuels, comparison of a Mid-Infrared process analyzer system based on TestMethod D6277 to a Test Method D3606 gas chromatography primary test method would be considered Case 1, and this practice would apply. For eachsample, the Mid-Infrared spectrum is converted into a single analyzer

28、 result using methodology (Test Method D6277) that is independent of the primarytest method (Test Method D3606). However, when the same analyzer uses a multivariate model to correlate the measured Mid-Infrared spectrum to TestMethod D3606 reference values using the methodology of Practice E1655, it

29、is considered Case 2 and Practice D6122 applies. In this case 2 example,the direct output of the analyzer is the spectrum, and the conversion of this multivariate output to an analyzer result require use of Practice D6122, henceit is not independent of the primary test method.1.7 Performance Validat

30、ion is conducted by calculating the precision and bias of the differences between results from theanalyzer system (or subsystem) after the application of any necessary correlation, (such results are herein referred to as PredictedPrimary Test Method Results (PPTMRs), versus the PTMRs for the same sa

31、mple set. Results used in the calculation are forsamples that are not used in the development of the correlation. The calculated precision and bias are statistically compared touser-specified requirements for the analyzer system application.1.7.1 For analyzers used in product release or product qual

32、ity certification applications, the precision and bias requirement forthe degree of agreement are typically based on the 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 describ

33、e procedures for establishing precision and bias requirements for analyzer systemapplications. Such requirements must be based on the criticality of the results to the intended business application and oncontractual and regulatory requirements. The user must establish precision and bias requirements

34、 prior to initiating the validationprocedures described herein.1.8 Two procedures for validation are described: the line sample procedure and the validation reference material (VRM)injection procedure.1.9 Only the analyzer system or subsystem downstream of the VRM injection point or the line sample

35、extraction point is beingvalidated by this practice.1.10 The line sample procedure is limited to applications where material can be safely withdrawn from the sampling point ofthe analyzer unit without significantly altering the property of interest.1.10.1 The line sample procedure is the primary opt

36、ion for when the validation is for (2b) materials including effect fromadditional treatment to the material.D3764 1521.11 Validation information obtained in the application of this practice is applicable only to the type and property range of thematerials used to perform the validation.1.12 Two type

37、s of validation are described: General Validation, and Level Specific Validation. These are typically conductedat installation or after major maintenance once the system mechanical fitness-for-use has been established.1.12.1 General Validation is based on the statistical principles and methodology o

38、f Practice D6708. In most cases, GeneralValidation is preferred, but may not always be possible if the variation in validation materials is insufficient. General Validationwill validate analyzer operation over a wider operating range than Level Specific Validation.1.12.2 When the variation in availa

39、ble validation materials is insufficient to satisfy the requirements of Practice D6708, a LevelSpecific Validation is done to validate analyzer operation over a limited range.1.12.3 The validation outcome are considered valid only within the range covered by the validation material Data from several

40、different Validations (general or level-specific) can potentially be combined for use in a General Validation.1.13 Procedures for the continual validation of system performance are described. These procedures are typically applied at afrequency commensurate with the criticality of the application.1.

41、14 This practice does not address procedures for diagnosing causes of validation failure.1.15 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practic

42、es and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D1265 Practice for Sampling Liquefied Petroleum (LP) Gases, Manual MethodD3606 Test Method for Determination of Benzene and Toluene in Finished Motor and Aviation Gasoline by Gas Chrom

43、atog-raphyD4057 Practice for Manual Sampling of Petroleum and Petroleum ProductsD4177 Practice for Automatic Sampling of Petroleum and Petroleum ProductsD5842 Practice for Sampling and Handling of Fuels for Volatility MeasurementD6122 Practice for Validation of the Performance of Multivariate Online

44、, At-Line, and Laboratory Infrared SpectrophotometerBased Analyzer SystemsD6277 Test Method for Determination of Benzene in Spark-Ignition Engine Fuels Using Mid Infrared SpectroscopyD6299 Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Meas

45、ure-ment System PerformanceD6708 Practice for Statistical Assessment and Improvement of Expected Agreement Between Two Test Methods that Purportto Measure the Same Property of a MaterialD7235 Guide for Establishing a Linear Correlation Relationship Between Analyzer and Primary Test Method Results Us

46、ingRelevant ASTM Standard PracticesD7278 Guide for Prediction of Analyzer Sample System Lag TimesD7453 Practice for Sampling of Petroleum Products forAnalysis by Process StreamAnalyzers and for Process StreamAnalyzerSystem ValidationD7808 Practice for Determining the Site Precision of a Process Stre

47、am Analyzer on Process Stream MaterialE456 Terminology Relating to Quality and StatisticsE1655 Practices for Infrared Multivariate Quantitative AnalysisF307 Practice for Sampling Pressurized Gas for Gas Analysis3. Terminology3.1 Definitions:3.1.1 accepted reference value (ARV), n a value that serves

48、 as an agreed-upon reference for comparison, and which is derivedas: (1) a theoretical or established value, based on scientific principles, (2) an assigned or certified value, based on experimentalwork of some national or international organization, or (3) a consensus or certified value, based on c

49、ollaborative experimental workunder the auspices of a scientific or engineering group. E4563.1.2 between-method reproducibility (RXY ), na quantitative expression of the random error associated with the differencebetween two results obtained by different operators using different apparatus and applying the two methods X and Y, respectively,each obtaining a single result on an identical test sample, when the methods have been assessed and an appropriate bias-correctionhas been applied in accordance with this practice; it is defined as the 95 % confidence limit for the