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:
- it provides a unique quality assurance (QA) program for
radiopharmaceuticals tied directly to national standards;
- the program reduces participants' production costs because it reduces
costly measurement conflicts between suppliers and customers;
- 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;
- the sponsors choose which radionuclides are to be scheduled for
production; and
- 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
Inquiries or comments:
daniel.golas@nist.gov
Online: March 1996
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