ASTM D3764-09
(Practice)Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
SIGNIFICANCE AND USE
This practice can be used to quantify the performance of a process stream analyzer system or its subsystem in terms of precision and bias relative to those of a primary test method for the property of interest.
This practice provides developers or manufacturers of process stream analyzer systems with useful procedures for evaluating the capability of newly designed systems for industrial applications that require reliable prediction of measurements of a specific property by a primary test method of a flowing component or product.
This practice provides purchasers of process stream analyzer systems with some reliable options for specifying acceptance test requirements for process stream analyzer systems at the time of commissioning to ensure the system is capable of making the desired property measurement with the appropriate precision or bias specifications, or both.
PPTMR from Analyzer Systems validated in accordance with this practice can be used to predict, with a specified confidence, what the PTMR would be, to within a specified tolerance, if the actual primary test method was conducted on the materials that are within the validated property range and type.
This practice provides the user of a process stream analyzer system with useful information from on-going quality control charts to monitor the variation in Δ over time, and trigger update of correlation relationship between the analyzer system and primary test method in a timely manner.
Validation information obtained in the application of this practice is applicable only to the material type and property range of the materials used to perform the validation. Selection of the property levels and the compositional characteristics of the samples must be suitable for the application of the analyzer system. This practice allows the user to write a comprehensive validation statement for the analyzer system including specific limits for the validated range of application. This practice does not recomme...
SCOPE
1.1 This practice describes procedures and methodologies based on the statistical principles of Practice D 6708 to validate whether the degree of agreement between the results produced by a total analyzer system (or its subsystem), versus the results produced by an independent test method that purports to measure the same property, meets user-specified requirements. This is a performance-based validation, to be conducted using a set of materials that are not used a priori in the development of any correlation between the two measurement systems under investigation. A result from the independent test method is herein referred to as a Primary Test Method Result (PTMR).
1.2 This practice assumes any correlation necessary to mitigate systemic biases between the analyzer system and PTM have been applied to the analyzer results.
1.3 This practice requires that both the primary method against which the analyzer is compared to, and the analyzer system under investigation, are in statistical control. Practices described in Practice D 6299 should be used to ensure this condition is met.
1.4 This practice applies if the process stream analyzer system and the primary test method are based on the same measurement principle(s), or, if the process stream analyzer system uses a direct and well-understood measurement principle that is similar to the measurement principle of the primary test method. This practice also applies if the process stream analyzer system uses a different measurement technology from the primary test method, provided that the calibration protocol for the direct output of the analyzer does not require use of the PTMRs (see Case 1 in Note 1).
1.5 This practice does not apply if the process stream analyzer system utilizes an indirect or mathematically modeled measurement principle such as chemometric or multivariate analysis techniques where PTMRs are required for the chemometric or multivariate model develop...
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Designation: D3764 − 09
StandardPractice for
Validation of the Performance of Process Stream Analyzer
1
Systems
This standard is issued under the fixed designation D3764; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Operation of a process stream analyzer system typically involves four sequential activities.
(1) Analyzer Calibration —When an analyzer is initially installed, or after major maintenance has
been performed, diagnostic testing is performed to demonstrate that the analyzer meets the
manufacturer’sspecificationsandhistoricalperformancestandards.Thesediagnostictestsmayrequire
that the analyzer be adjusted so as to provide predetermined output levels for certain reference
materials. (2) Correlation—Once the diagnostic testing is completed, process stream samples are
analyzed using the analyzer system. For application where the process analyzer system results are
required to agree with results produced from an independent (primary) test method (PTM), a
mathematical function is derived that relates the analyzer results to the primary test method results
(PTMR). The application of this mathematical function to an analyzer result produces a predicted
primary test method result (PPTMR). (3) Probationary Validation—After the correlation relation-
shipbetweentheanalyzerresultsandprimarytestmethodresultshasbeenestablished,aprobationary
validation is performed using an independent but limited set of materials that were not part of the
correlation activity. This probationary validation is intended to demonstrate that the PPTMRs agree
with the PTMRs to within user-specified requirements for the analyzer system application. (4)
General and Continual Validation—After an adequate amount of PPTMRs and PTMRs have been
accrued on materials that were not part of the correlation activity, a comprehensive statistical
assessment is performed to demonstrate that the PPTMRs agree with the PTMRs to within the
tolerances established from the correlation activities. Subsequent to a successful general validation,
qualityassurancecontrolchartmonitoringofthedifferencesbetweenPPTMRandPTMRisconducted
duringnormaloperationoftheprocessanalyzersystemtodemonstratethattheagreementbetweenthe
PPTMRsandPTMRsestablishedintheGeneralValidationismaintained.Thispracticedealswiththe
third and fourth of these activities.
1. Scope investigation. A result from the independent test method is
herein referred to as a Primary Test Method Result (PTMR).
1.1 This practice describes procedures and methodologies
1.2 This practice assumes any correlation necessary to
basedonthestatisticalprinciplesofPracticeD6708tovalidate
whether the degree of agreement between the results produced mitigatesystemicbiasesbetweentheanalyzersystemandPTM
byatotalanalyzersystem(oritssubsystem),versustheresults have been applied to the analyzer results.
produced by an independent test method that purports to
1.3 This practice requires that both the primary method
measure the same property, meets user-specified requirements.
against which the analyzer is compared to, and the analyzer
This is a performance-based validation, to be conducted using
system under investigation, are in statistical control. Practices
a set of materials that are not used a priori in the development
described in Practice D6299 should be used to ensure this
ofanycorrelationbetweenthetwomeasurementsystemsunder
condition is met.
1.4 This practice applies if the process stream analyzer
1
system and the primary test method are based on the same
This practice is under the jurisdiction ofASTM Committee D02 on Petroleum
ProductsandLubricantsandisthedirectresponsibilityofSubcommitteeD02.25on
measurement principle(s), or, if the process stream analyzer
Performance Assessment and Validation of Process Stream Analyzer Systems.
system uses a direct and well-understood measurement prin-
CurrenteditionapprovedJune1,2009.PublishedJuly2009.Originallyapproved
´1
ciplethatissimilartothemeasurementprincipleoftheprimary
in 1980. Last previous edition approved in 2006 as D3764–06 . DOI: 10.1520/
D3764-09. test method. This practice also applies if the process stream
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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D3764 − 09
analyzersystemusesadifferentmeasurementtechnologyfrom 1.10 Validation information obtained in the application of
the primary test method, provided that the calibration protocol this practice is applicable only to the type and property range
for the direct output
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it 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 version
of the standard as published by ASTM is to be considered the official document.
´1
Designation:D3764–06 Designation:D3764–09
Standard Practice for
Validation of the Performance of Process Stream Analyzer
1
Systems
This standard is issued under the fixed designation D3764; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
´ NOTE—Updated Fig. 5 editorially in November 2006.
INTRODUCTION
Operation of a process stream analyzer system typically involves four sequential activities.
(1) Analyzer Calibration —When an analyzer is initially installed, or after major maintenance has
been performed, diagnostic testing is performed to demonstrate that the analyzer meets the
manufacturer’sspecificationsandhistoricalperformancestandards.Thesediagnostictestsmayrequire
that the analyzer be adjusted so as to provide predetermined output levels for certain reference
materials. (2) Correlation—Once the diagnostic testing is completed, process stream samples are
analyzed using the analyzer system. For application where the process analyzer system results are
required to agree with results produced from an independent (primary) test method (PTM), a
mathematical function is derived that relates the analyzer results to the primary test method results
(PTMR). The application of this mathematical function to an analyzer result produces a predicted
primary test method result (PPTMR). (3) Probationary Validation—After the correlation relation-
shipbetweentheanalyzerresultsandprimarytestmethodresultshasbeenestablished,aprobationary
validation is performed using an independent but limited set of materials that were not part of the
correlation activity. This probationary validation is intended to demonstrate that the PPTMRs agree
with the PTMRs to within user-specified requirements for the analyzer system application. (4)
General and Continual Validation—After an adequate amount of PPTMRs and PTMRs have been
accrued on materials that were not part of the correlation activity, a comprehensive statistical
assessment is performed to demonstrate that the PPTMRs agree with the PTMRs to within the
tolerances established from the correlation activities. Subsequent to a successful general validation,
qualityassurancecontrolchartmonitoringofthedifferencesbetweenPPTMRandPTMRisconducted
duringnormaloperationoftheprocessanalyzersystemtodemonstratethattheagreementbetweenthe
PPTMRsandPTMRsestablishedintheGeneralValidationismaintained.Thispracticedealswiththe
third and fourth of these activities.
1. Scope
1.1 This practice describes procedures and methodologies based on the statistical principles of Practice D6708 to validate
whether the degree of agreement between the results produced by a total analyzer system (or its subsystem), versus the results
produced by an independent test method that purports to measure the same property, meets user-specified requirements. This is a
performance-based validation, to be conducted using a set of materials that are not used a priori in the development of any
correlationbetweenthetwomeasurementsystemsunderinvestigation.Aresultfromtheindependenttestmethodishereinreferred
to as a Primary Test Method Result (PTMR).
1.2 This practice assumes any correlation necessary to mitigate systemic biases between the analyzer system and PTM have
been applied to the analyzer results.
1.3 This practice requires that both the primary method against which the analyzer is compared to, and the analyzer system
underinvestigation,areinstatisticalcontrol.PracticesdescribedinPracticeD6299shouldbeusedtoensurethisconditionismet.
1
This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products and Lubricants and is the direct responsibility of Subcommittee D02.25 on
Performance Assessment and Validation of Process Stream Analyzer Systems for Petroleum and Petroleum Products.
Current edition approved July 1, 2006. Published August 2006. Originally approved in 1980. Last previous edition approved in 2001 as D3764–01.on Performance
Assessment and Validation of Process Stream Analyzer Systems.
´1
Current edition approved June 1, 2009. Published July 2009. Originally approved in 1980. Last previous edition approved in 2006 as D3764–06 .
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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D3764–09
1.4 Thispr
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