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Is your technetium generator eluate sterile?

G M Snowdon1

  • 1Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, Australia. gsnowdon@doh.health.nsw.gov.au

Journal of Nuclear Medicine Technology
|May 29, 2000
PubMed
Summary

Sterility testing of technetium-99m (99mTc) generator eluate vials confirmed the safety of radiopharmaceutical preparation protocols. This quality control measure ensures the integrity of eluate used in nuclear medicine procedures.

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Area of Science:

  • Nuclear Medicine
  • Radiopharmacy
  • Microbiology

Background:

  • Multidose vials of technetium-99m (99mTc) generator eluate are critical in nuclear medicine.
  • Ensuring the sterility of these eluate vials is paramount for patient safety.

Purpose of the Study:

  • To evaluate the sterility of multidose 99mTc generator eluate vials at the conclusion of a standard working day.
  • To validate the departmental protocol for radiopharmaceutical preparation.

Main Methods:

  • Expired 99mTc generator eluate vials were collected over 10 weeks.
  • Vials were stored until radioactivity reached background levels.
  • Four random batches of 10 vials underwent independent laboratory sterility testing.

Main Results:

  • No microbial growth was detected in any eluate samples after 14 days of incubation.
  • The results indicate a lack of microbial contamination in the tested eluate vials.

Conclusions:

  • Retrospective sterility testing validates the established departmental protocol for radiopharmaceutical preparation.
  • Sterility testing is now an integral part of the quality control program for 99mTc eluate.

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