Competency information

Details

Undertake radiochemical purity testing, interpret and report on the results.

Considerations

  • Control of quality and the role of the quality controller.
  • Techniques and instrumentation:
    • thin-layer chromatography (TLC)
    • high-performance liquid chromatography (HPLC)
    • gas chromatography
    • ion separation chromatography
    • endotoxin and pyrogen testing (theory)
    • pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
  • Product testing:
    • purchased medicines
    • raw materials
    • final products.

Relevant learning outcomes

# Outcome
# 5 Outcome Perform quality assurance tests of equipment used in the preparation and quality control of radiopharmaceuticals.
# 8 Outcome Assess and interpret radiopharmaceutical in-process and end products quality test results, e.g. high-performance liquid chromatography (HPLC), thin-layer chromatography (TLC), pyrogen tests, etc.