Technetium99mGeneratorQualityChecker

Technetium-99m Generator Quality Checker — Molybdenum-technetium generator (Ph. Eur. 2.14.1, USP <823>)

ℹ️  Utility checks critical eluate parameters: molybdenum-99 and iodine-131 breakthrough (calculated as % of Tc-99m activity), eluate volume, eluate pH.
ℹ️  Does not use machine learning — only mathematical calculation of breakthrough percentages and pharmacopoeial limit checks.
⚠️  CRITICAL: Mo-99 breakthrough (≤0.015%) — unacceptable due to long half-life (66 hours)! Even minor breakthrough creates chronic radiation burden to patient. I-131 breakthrough (≤0.001%) — critical for Mo-99 produced by uranium fission!

Usage:
  Technetium99mGeneratorQualityChecker.exe                            → demo mode (console output)
  Technetium99mGeneratorQualityChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,Tc99mActivityMBq,Mo99ActivityMBq,I131ActivityMBq,EluateVolumeMl,EluatePH

Field explanation:
• Tc99mActivityMBq — technetium-99m activity in eluate at measurement time (MBq)
• Mo99ActivityMBq — molybdenum-99 activity in same eluate sample (MBq)
• I131ActivityMBq — iodine-131 activity in same eluate sample (MBq)
• EluateVolumeMl — volume of obtained eluate (mL)
• EluatePH — pH of eluate

Example:
  Tc99m-Gen-2026-001,1000.0,0.15,0.01,5.0,6.0
  → Mo-99 breakthrough = (0.15 / 1000.0) × 100% = 0.015% (at limit)
  → I-131 breakthrough = (0.01 / 1000.0) × 100% = 0.001% (at limit)

— WHY IS THIS NEEDED?
Molybdenum-technetium generators — primary source of technetium-99m for diagnostic imaging:
• Daily production of sterile, apyrogenic eluate with Tc-99m
• Used for cardiac, bone, renal, thyroid scintigraphy etc.
• Generator contains Mo-99 (T½=66 h) decaying to Tc-99m (T½=6 h)
⚠️ CRITICAL:
• Mo-99 breakthrough ≤0.015% — Mo-99 has 66-HOUR half-life! Even 0.016% creates significant chronic radiation burden to patient during diagnostics. Unacceptable for clinical use!
• I-131 breakthrough ≤0.001% — critical for Mo-99 produced by uranium-235 fission. I-131 accumulates in thyroid gland, creating unnecessary radiation dose.
• Eluate volume 3–10 mL — ensures optimal Tc-99m concentration for subsequent radiopharmaceutical labeling
• Eluate pH 4.5–7.5 — critical for compatibility with labeling kits (e.g., MIBI, DTPA, MAG3). Outside range — reduced labeling yield!
⚠️ Special attention: Mo-99 breakthrough measured 24 hours after last elution (maximum breakthrough). Mo-99 and Tc-99m activity measurements MUST be performed at the SAME TIME! Calculation: (Mo-99 Activity / Tc-99m Activity) × 100%. I-131 breakthrough checked only for generators with fission-produced Mo-99. For reactor-produced Mo-99 (activation), this parameter is less critical but still required by specification.
Critical parameters:
• Mo-99 breakthrough: ≤0.015% of Tc-99m activity (Ph. Eur. 2.14.1, USP <823>)
• I-131 breakthrough: ≤0.001% of Tc-99m activity (for fission-produced Mo-99 generators)
• Eluate volume: 3.0–10.0 mL
• Eluate pH: 4.5–7.5
⚠️ Note: Utility calculates breakthrough percentage AUTOMATICALLY from measured activities. This eliminates human error in manual calculations. All activity measurements must be decay-corrected and performed on calibrated detector. Generator is considered unfit if Mo-99 breakthrough exceeds limit even by 0.001%!