ASTM D3764-15e1
(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
5.1 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.
5.2 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.
5.3 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.
5.4 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.
5.5 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.
5.6 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. Th...
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 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).
1.1.1 The degree of agreement described in 1.1 can be either for the same materials, or, for materials including effect from additional treatment to the basestock material.
Note 1: Subsection 1.1.1 refers to the application where PPTMR for the same material can be used as an input to a mathematical model to predict the effect of an additive added to the basestock material as by a PTM.
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. See Guide D7235 for procedures for establishing such correlations.
1.3 This practice assumes any modeling techniques employed have the necessary tuning to mitigate systemic biases between the 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 compared to, and the analyzer system under 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 ...
General Information
Relations
Buy Standard
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
´1
Designation: D3764 − 15
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
ε NOTE—Editorial changes made throughout in July 2015.
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. (2a) Correlation for the Same Material—Once the diagnostic testing is completed,
process stream samples are analyzed using the analyzer system. For application where the process
analyzersystemresultsarerequiredtoagreewithresultsproducedfromanindependent(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), for the same material. (2b) Correlation for
Material including Effect from Additional Treatment to the Material—ThePPTMRin (2a)canbe
usedasaninputtoamathematicalmodeltopredicttheeffectofanadditiveand/orablendstockadded
toabasestockmaterialasmeasuredbyaPTM. (3) Probationary Validation—Afterthecorrelation(s)
relationship between the analyzer results and primary test method results has been established, a
probationary 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
PTMRshavebeenaccruedonmaterialsthatwerenotpartofthecorrelationactivity,acomprehensive
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, quality assurance control chart monitoring of the differences between PPTMR and PTMR
is conducted during normal operation of the process analyzer system to demonstrate that the
agreementbetweenthePPTMRsandPTMRsestablishedintheGeneralValidationismaintained.This
practice deals with the third and fourth of these activities.
“Correlation for material including effect from additional treatment to the material” as outlined in
this standard is intended primarily to be applied to biofuels where the biofuel material is added at a
terminal or other facility and not included in the process stream material sampled by the analyzer at
the basestock manufacturing facility. The correlation shall be specific for a constant percentage
addition of the biofuels material to the basestock for each model. This practice may not apply for
physical properties where the source material for the biofuel material or the denaturant/diluent
materialusedwiththebiofuelmaterialcansignificantlyaffectthefinishedbiofuel’sphysicalproperty.
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 may 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 States
1
---------------------- Page: 1 ----------------------
´1
D3764 − 15
NOTE 2—For example, for the measurement of benzene in spark
1. Scope*
ignition fuels, comparison of a Mid-Infrared process analyzer system
1.1 This practice describes procedures and methodologies
based on Test Method D6277 to a Test Method D3606 gas chromatogra-
basedonthestatisticalprinciplesofPracticeD6708tovalidate
phy primary test method would be considered Case 1, and this practice
would apply. For each sample, the Mid-Infrared spectrum is converted
whether the degree of agreement between the results produced
intoasingleanalyzerresultusingmethodology(TestMethodD6277)that
byatotalanalyzersystem(oritssubsystem),versustheresults
isindependentoftheprimarytestmethod(TestMethodD3606).However,
produced by an independent test method t
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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 − 15 D3764 − 15
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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Editorial changes made throughout in July 2015.
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’s specifications and historical performance standards. These diagnostic tests may require
that the analyzer be adjusted so as to provide predetermined output levels for certain reference
materials. (2a) Correlation for the Same Material—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), for the same material. (2b) Correlation for
Material including Effect from Additional Treatment to the Material—The PPTMR in (2a) can be
used as an input to a mathematical model to predict the effect of an additive and/or a blend stock
blendstock added to a base stock basestock material as measured by a PTM. (3) Probationary
Validation—After the correlation(s) relationship between the analyzer results and primary test
method results has been established, a probationary 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, quality assurance control chart monitoring of the differences between
PPTMR and PTMR is conducted during normal operation of the process analyzer system to
demonstrate that the agreement between the PPTMRs and PTMRs established in the General
Validation is maintained. This practice deals with the third and fourth of these activities.
“Correlation for material including effect from additional treatment to the material” as outlined in
this standard is intended primarily to be applied to biofuels where the biofuel material is added at a
terminal or other facility and not included in the process stream material sampled by the analyzer at
the base stock basestock manufacturing facility. The correlation shall be specific for a constant
percentage addition of the biofuels material to the base stock basestock for each model. This practice
may not apply for physical properties where the source material for the biofuel material or the
denaturant/diluent material used with the biofuel material can significantly affect the finished biofuel’s
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 blendstock material composition when
1
This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products, Liquid Fuels, and Lubricants and is the direct responsibility of Subcommittee
D02.25 on Performance Assessment and Validation of Process Stream Analyzer Systems.
Current edition approved April 1, 2015. Published May 2015. Originally approved in 1980. Last previous edition approved in 2013 as D3764 – 13. DOI:
10.1520/D3764-15.10.1520/D3764-15E01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- P
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.