Measurement and Standards Needs for an Advanced Biofuels Economy by e295e75ae2526297


									 Measurement and Standards
Needs for an Advanced Biofuels
          Willie E. May
           NIST, US
Why Increased Interest in Biofuels
                       “Energy Crisis”

Timing is Right to Explore Biofuels as an Energy
Source because:

• Increasing Energy Costs
• Decreasing Supply and Availability of Fossil Fuels
• Relative Environmental Friendliness
   – Including positive Climate Change implications
• Advances in Science and Technology
• Global Commitment of Governments
• Social Readiness
Critical data, Test Methods and CRMs needed for:

Assessment of Feedstocks
Optimization of Conversion Technologies

Supporting Infrastructure for Distribution and End-Use


                       • Engine Performance
                       • Engine Life
                       • Environmental
                Infrastructural Needs
•   Standards, Codes and Specifications
    – Feed Stocks
    – Biofuels as additives
    – Finished Fuel Products

•   Metrology
    – Test Methods
    – Certified Reference Materials
        • Instrument Calibration
        • Test Method Validation
    – Proficiency Assessments of Testing Labs??

•   Fuel Property Data and Simulations

•   Materials Research, Data and Testing Technology
      Ethanol Specification
The product should be evaluated against
defined and sound methods of analysis and
units, and be understandable by all people
involved in the operation.
The definition and implementation of a
specification and quality system is a complex
task that has to involve skilled people from all
the supplier-user chain.

          José Felix Silva Junior
Methods for Anhydrous Fuel
    José Felix Silva Junior

Methods developed for other matrix is
used for ethanol. Who tested them?
Methods for denatured ethanol are
asked   for  undenatured  one   –
Tables for density are different –
IUPAC, OIML, in air, in vacuum.
     Standard Harmonization
• Maybe we should not talk of “harmonization”,
  but instead consider our task an opportunity
  to work together to…
  – Better understand the standards of others in
    hopes of improving our own
  – Make contact and friends

• Test methods should be compared before
  standard properties
• Test method experts and standard experts
  are most likely different individuals.
                   Dr. Ben Bonazza
 NIST-INMETRO Symposium on Biofuels – Washington, DC
                   June 26-29, 2007
               Consumer Acceptance of
               RELIABLE QUALITY

                                                          DOCUMENTARY STANDARDS
                                                           Biodiesel: ASTM D6751-06a
                                                         Bioethanol: D4806, D4814, D5798



         SOLUTIONS                                            TEST

                                                            METHODS          SPECIFICATIONS


                                                                METHOD VALIDATION
     SOLUTION                                                                          S. Wise
       SRMs                                      MATRIX-MATERIAL SRMs                  NIST
                 Next Steps
• Two Ideas
  – Summit Meeting Among Standardization
   Bodies, Test Method Developers/Providers,
   Reference Materials Providers
    • Joint Committee on Traceability for Biofuel
      Measurements ?

  – Classification Scheme for Biofuel Feedstocks
                            Food Safety and Nutrition
 •    Nutritional Labeling Law
 •    Contaminants and Adulterants
 •    Biotech Foods
 •    Dietary Supplements
 •    Human Nutrition Assessment

                           0% Protein
                           100% Fat

                                    +   ++
                       2            3    4
              +       6
                      +             7    8       9
                                +            +
              +                                      +
0% Fat  + +                    +
                                                        100% Protein
100% Carbohydrate                                    0% Carbohydrate
Joint Committee on Traceability in Laboratory Medicine

         Database of Higher Order Reference Materials
           and Reference Measurement Procedures

 A joint venture of professionals, metrology institutes, regulators
                          and IVD-industry
Requirement of EC-IVD Directive Annex 1 (3)

“The traceability of values assigned to calibrators and/or control materials
must be assured through available reference measurement procedures
and/or available reference materials of a higher order.”

Aim of the IVD Directive
“to ensure that IVDs do not compromise the health and safety of patients,
users and third parties and attain the performance levels attributed to them
by their manufacturer. "

       US IVD Manufacturers requested that NIST and other NMIs develop
      reference materials and measurement procedures to assist them in
      meeting this new traceability requirement.
First Step Toward a Solution
           Attendees included:
           •   IVD Manufacturers
           •   Regulatory Agencies and Notified Bodies
           •   Providers of Proficiency Testing Programs,
               Laboratory Accreditation, and Measurement
               Quality assessment Materials
           •   Laboratory professionals involved in
               standardization of laboratory methods
           •   International Standards Laboratories

           Recommendations included:
           Establishment of a global consortium of IVD
           manufacturers, professional societies, NMIs, and
           regulatory bodies to develop an international
           consensus-based reference system for
           laboratory medicine.
                   LABORATORY MEDICINE

That global body was established in Paris on 12 June 2002, to meet the need
for a worldwide platform to promote and give guidance on internationally recognized
and accepted equivalence of measurements in Laboratory Medicine and traceability
to appropriate measurement standards.

The Declaration of Cooperation was between the International Committee of
Weights and Measures (CIPM), the International Federation for Clinical Chemistry
and Laboratory Medicine (IFCC),and the International Laboratory Accreditation
Cooperation (ILAC)
JCTLM – Mission Statement
JCTLM – Structure of the Organization

     JCTLM Executive
     Chair: Jos Thijssen → Jean-Claude Forest

     Executive Secretary: R. Wielgosz (BIPM)

     Representatives of founding organizations
      BIPM – Terry Quinn → Andrew Wallard
      IFCC – Mathias Mueller
      ILAC – Alan Squirrel

     Executive Responsibilities
JCTLM – Structure of the Organization

Task-Oriented Working Groups and Review Teams

  WG1 - Reference Materials and Reference Methods
  WG2 - Reference Laboratory Networks for Delivering
        Reference Measurement Services
    JCTLM Working Group I on Reference Materials and
             JCTLM Working Group 1
          Reference Measurement Procedures

     Co-Chairs: W.E. May (NIST), H. Schimmel (IRMM)

Charged with:

• establishing a process for identifying, and reviewing against
  agreed upon criteria “higher order” Certified Reference
  Materials and Reference Measurement Procedures required for
 IVD industry compliance with the EC IVD Directive regarding in vitro
 diagnostic medical devices.

• publishing a List of “higher order” Certified Reference Materials and
 Reference Measurement Procedures required for IVD industry compliance
 with the EC IVD Directive regarding in vitro diagnostic medical devices.
               JCTLM Working Group 2

Co-Chairs: L. Siekmann (U. Bonn), L. Thienpont (U. Gent)

WG2 charged with:
  Collecting information on services provided by existing and
  candidate reference measurement laboratories (RMLs)
  Encouraging and facilitating the formation of networks of RMLs for
  different groups of measurable quantities (e.g. electrolytes,
  substrates/metabolites, enzymes, HbA1c, low molecular
  hormones, ...)
  Establishing a procedure for the approval of RMLs on the basis of
  their metrological level according to ISO 15195 and their performance
  as demonstrated in inter-laboratory comparisons linked to an NMI.
      JCTLM Review Process is Transparent

… based on openly available written procedures with defined
criteria for review based on the criteria specified in the
applicable ISO documents.

    Relevant ISO Standards
• ISO 17511   In vitro diagnostic medical devices -

• ISO 18153   Metrological traceability of values for
              catalytic concentration of enzymes
              assigned to calibrators and control
• ISO 15193   Presentation of reference
              measurement procedures
• ISO 15194   Description of reference material
• ISO 15195   Reference Measurement Laboratories
             JCTLM Measurand-Based Review Teams
             WG 1 – Analyte-Based Review Teams

   Coagulation Factors                     Elaine Gray, NIBSC, United Kingdom
   Drugs                                   Andre Henrion, PTB, Germany
   Electrolytes                            Richard Miller, Dade Behring, United States
   Enzymes                                 Mauro Panteghini, University of Milan, Italy
   Metabolites/Substrates                  Michael Welch, NIST, United States
   Nucleic Acids                           Helen Parkes, LGC, United Kingdom
   Non-Peptide Hormones                    Heinz Schimmel, IRMM, European Union
   Proteins                                David Sogin, Abbott Laboratories, United States
   Blood Group Substances                  Susan Thorpe, NIBSC, United Kingdom
   Viral Markers                           Morag Ferguson, NIBSC, United Kingdom
   Vitamins                                Katherine Sharpless, NIST, United States
   Non-electrolyte Metals                  Lee Yu, NIST, United States
   Blood Gases                             Merged with Electrolytes, November 3, 2005

   Quality System                          Craig M Jackson, HDC, United States
Review Teams established with worldwide representation from Laboratory Accreditation Organizations,
National Metrology Institutes, Professional Societies, and IVD Industry in order to facilitate a fair and
transparent review process.
  WG 1 – Listed Higher Order Reference Materials
 and Reference Measurement Methods/Procedures

Certified Reference Materials and Reference
Measurement Procedures for well-defined chemical
entities or internationally recognized reference method-
defined measurands,

          published initially on 01 April 2004, contains

     • 123 Reference Measurement Procedure entries for
       75 different health status markers
     • 211 Reference Material entries for 128 measurands
Home page
JCTLM Database: Laboratory medicine and in vitro diagnostics

JCTLM-DB                         Database of higher-order reference materials and
 - JCTLM-DB home                       reference measurement procedures
 - Search form
 - Preamble                  Search the database
 - Quality manual
 - Review Teams
                            List I : Certified Reference Materials and Reference Measurement
 - Nomination forms         Procedures for well-defined chemical entities or internationally
 - JCTLM                    recognized          reference          method-defined             measurands.
                            Reference Materials and Measurement Procedures included in this category are
                            those that provide values that are traceable to the SI units; e.g., electrolytes,
Contact                     enzymes, drugs, metabolites and substrates, non-peptide hormones and some
 -JCTLM Secretariat
                            List II: Reference Materials (e.g. reference materials for blood typing,
                            coagulation factors, microbial serology, nucleic acids, and some proteins)
Useful links                that are value-assigned using an internationally agreed upon protocol.
                            The values of the measurands in the reference materials on this List are not SI-
 - ILAC                     traceable and/or no internationally-recognized reference measurement procedure
 - IFCC                     exist. List II also contains a group of purified substances that due to the absence of
                            reference measurement procedures should not be directly used for calibration
 - KCDB                     unless commutability is established.
 - Metrologia

   Bureau International des Poids et Mesures
                                                     Comparability of Cholesterol in Serum
                                                           CRMs on JCTLM LIST
                                                                                SRM 1952a l-3


                                                                                                       Measured / Certified Value

                                                                                  SRM 1951a l-2
Measured Value, mg/dL

                                                                              JCCRM M

                                                    SRM 1952a l-2      SRM 909b l-2                                                 0.99

                                                              JCCRM H
                        200                                                                                                         0.98
                               SRM 909b l-1

                                                       SRM 1951a l-1

                                                   SRM 968c l-2
                                                SRM 1589a                                                                                                                                                                                      Med = 0.9933

                                                                                                                                           JCCRM H

                                                                                                                                           JCCRM M

                                                                                                                                                                                   SRM 1589a

                                                                                                                                                                                               SRM 1951a l-1
                                                                                                                                                                                               SRM 1951a l-2

                                                                                                                                                                                                               SRM 1952a l-1
                                                                                                                                                                                                               SRM 1952a l-2
                                                                                                                                                                                                                               SRM 1952a l-3
                                                                                                                                                     SRM 909b l-1
                                                                                                                                                     SRM 909b l-2

                                                                                                                                                                    SRM 968c l-1
                                                                                                                                                                    SRM 968c l-2
                                              SRM 1952a l-1                                                                                                                                                                                    Med:s = 0.0069

                                   SRM 968c l-1                                                                                                                                                                                                U(Med) = 0.0055

                                      150               200            250            300

                                                                                                  The measured/certified ratios for this
                                 CRM comparability                                                set of CRMs are:
                              independent of analyte                                               • ~ normally distributed
                                      level                                                        • with a standard deviation of ~0.7%
                                 Assessment of Comparability of Two RMPs
                                 for Total Cholesterol in Liquid Frozen Serum

                                                                                                                                            Bias = X%
                                                                                                                                            u(Bias) = X ±Y%

                                                                             100*(AK - IDMS)/Mean, %
Abel Kendall, mg/dL



                      150                                  Equality
                                                           Single Source
                                                           Multiple Source
                                                                                                         100   150             200                250

                         100           150           200           250
                                                                                                                 Total Cholesterol, mg/dL
                               Isotope Dilution Mass Spectrometry, mg/dL

                               Measurements performed at NIST and CDC; publication to be forthcoming
                     “Energy Crisis”

Timing is Right to Explore Alternative Fuels for
           The Biorefinery Initiative:
           Accelerating research into "cellulosic
           ethanol" can make it cost-competitive by
           2012, offering the potential to displace up
           to 30% of the current US fuel use.

            We must also change how we power our
            automobiles … fund additional research in cutting-
            edge methods of producing ethanol, not just from
            corn, but from wood chips and stalks, or switch
            grass. Our goal is to make this new kind of ethanol
            practical and competitive within six years.

            GW Bush
            State of the Union Address, 2006

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