Establishing radiopharmaceutical standards at a nuclear medicine unit in Malta

Abstract

Purpose: To establish radiopharmaceutical standards in a Nuclear Medicine Department in terms of radiochemical purity. Radionuclide standards were assessed in terms of radionuclide and chemical purity as well as pH as part of a quality control (QC) programme.

Objectives: An accurate and complete literature search was conducted identifying the needs, specific tests and resources required for the QC programme. A QC protocol was implemented; data collected and findings documented determining current standards and the impact of implementation of a QC programme on work practice.

Methodology: Quantitative data was collected by means of a prospective, non-experimental research design. QC of the radionuclide was performed on all the accessible population, while random sampling was utilized to select a sample to determine the radiochemical purity of radiopharmaceuticals included in the study.

Results: Findings indicate that the radionuclide always met the required standards, which were in accordance with the European Pharmacopeia. The radionuclide purity was up to standards since 99Mo never exceeded more than 0.1% of the total 99mTc activity. The test for chemical purity showed that no samples contained Al3+ and the pH values measured all fell within the accepted range of 4-8. The results however revealed that substandard radiopharmaceuticals were frequently prepared, since the radiochemical purity of several (60.6%) samples fell below the lower limit of acceptance.

Conclusion: The findings indicate that substandard radiopharmaceuticals were a result of preparation error. The results were presented to all staff and work practices are currently being altered to improve radiopharmaceutical standards. The implementation of a full QA programme for radiopharmaceuticals is also in prospect.