Measurements and Calibrations

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Radiopharmaceutical Industry
NEI/NIST Measurement Assurance Program

Background

Since the early 1970's the Nuclear Energy Institute (NEI, originally the Atomic Industrial Forum) and the National Institute of Standards and Technology (formerly the National Bureau of Standards) have cooperated in a measurements assurance program in the field of nuclear medicine. Participation in the program allows sponsors an independent verification, traceability to NIST, of their capability to make accurate radioactivity measurements, as described in NRC Regulatory Guide 4.15, in order to demonstrate compliance with NRC and FDA regulations.

Participants find the program useful because:
  1. it provides a unique quality assurance (QA) program for radiopharmaceuticals tied directly to national standards;
  2. the program reduces participants' production costs because it reduces costly measurement conflicts between suppliers and customers;
  3. sponsors receive monthly feedback on their measurement procedures so that they can promptly determine if their measurement procedures or instruments have gone awry, or if the measurements are satisfactory, they receive reassurance and confidence that they are performing good measurements and providing accurately dispensed products;
  4. the sponsors choose which radionuclides are to be scheduled for production; and
  5. the activity levels in the standards are close to the actual activity levels that they routinely measure.

Program

The Program includes:
  • Distribution of radioactivity Standard Reference Materials (usually a high level [107 Bq to 1010 Bq] and low level [106 Bq to 108 Bq] pair of sources), for quantification, to sponsoring participating companies ten times per year.
  • Analysis and interpretation of the sponsor's quantification of the distributed radioactivity standards to identify any discrepancies in the measurements.
  • Two ``open'' months per year when the sponsors have the opportunity to send in sources of their choice for calibration. Sponsors use these months to:
    • Submit radionuclides that they sell but are not on the schedule for NIST production during the current year.
    • Submit samples to resolve measurement conflicts between suppliers or customers.
    • Document measurement capabilities on newly calibrated radionuclides when submitting New Drug Application (NDAs) to the U.S. Food and Drug Administration (FDA).
  • Assistance to sponsoring participants in eliminating difficulties and correcting errors in their measurement techniques.
  • NIST traceability certificates provided without charge to sponsors.

Sources

A typical schedule of Standard Reference Materials (SRMs) for a year:
Month Radionuclide High Level Low Level
January 131I 750 MBq (20 mCi) 25 MBq (700 µCi)
February 99Mo 3 GBq (80 mCi) 75 MBq (2 mCi)
March 133Xe 7.5 GBq (200 mCi) 750 MBq (20 mCi)
April 67Ga 375 MBq (10 mCi) 20 MBq (500 µCi)
May OPEN n/a n/a
June 201Tl 225 MBq (6 mCi) 35 MBq (900 µCi)
July 153Sm 110 MBq (3 mCi) 10 MBq (250 µCi)
August 111In 375 MBq (10 mCi) 20 MBq (500 µCi)
September   99mTc   7.5 GBq (200 mCi)   n/a
October 32P 2.2 GBq (60 mCi) 13 MBq (350 µCi)
November OPEN n/a n/a
December 125I 750 MBq (20 mCi) 6 MBq (150 µCi)
Steering Committee
A Steering Committee with a representative from each sponsor reviews the program at least annually and determines the programs technical content. The Steering Committee is headed by a chairman chosen from one of the participating companies.

Sponsoring Fee
The current sponsoring fee is $6,000 per year. For this $6,000 the sponsors receive two open month calibrations at no charge. Additionally, each sponsor may purchase as many high- and low-level SRMs as desired at $595.00 for each high level, and $545.00 for each low level.

Technical Program Information
For additional information on the technical program, please call Daniel Golas, the program's Project Manager, or Ofelia Palabrica, the program's Research Associate, at NIST (301) 975-5540/5255.

To Become a Sponsor
For information on becoming a sponsor of the NEI/NIST Radioactivity Measurements Assurance Program, please call Felix M. Killar, Jr. of NEI at (202) 739-8126.
Radioactivity Group   |   Ionizing Radiation Division

NIST: National Institute of Standards and Technology NIST Physics Laboratory HomeMeasurements and Calibrations Inquiries or comments: daniel.golas@nist.gov
Online: March 1996