Thorium227QualityChecker

1. Scope

This document defines requirements and functional behaviour for Thorium227QualityChecker used to control: Thorium-227. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• Thorium227QualityChecker.exe — demo mode or help output.
• Thorium227QualityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Thorium-227 Quality Checker — Alpha Therapy (Ph. Eur., USP)
• ℹ️ The utility checks RCP, free thorium, daughter nuclides, long-lived impurities, sterility.
• ⚠️ CRITICAL! Free Th ≤5%. Daughter escape ≤10%. Long-lived impurities ≤0.1%!
• BatchNumber,Radiopharmaceutical,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_mg_Ab,Long_Lived_Th_Impurities_Percent,Free_Thorium_Ion_Percent,Daughter_Nuclide_Escape_Percent,pH_Value,Protein_Concentration_mg_per_mL,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
• Thorium-227 — alpha-emitter for targeted therapy (T1/2 = 18.7 d):
• • Radiochemical Purity: Chelate stability is critical. Alpha decay causes nuclear recoil, which can break the bond with the chelator. Release of daughter nuclides (Ra-223, Rn-219) leads to their accumulation in bones and other organs, causing toxicity. Daughter escape limit is typically ≤10%.
• • Free Thorium: Accumulates in liver and bones. Limit ≤5%.
• • Sterility and Endotoxins: Drug is administered intravenously. Requirements are strict.
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.0%
• • Radiochemical Purity: ≥ 95.0%
• • Long-Lived Impurities (Th-228/232): ≤ 0.1%
• • Free Thorium: ≤ 5.0%
• • Daughter Nuclide Escape: ≤ 10.0%
• • Specific Activity: ≥ 1.0 MBq/mg antibody
• • pH: 5.0–7.5
• • Endotoxins: ≤ 17.5 EU/mL
• • Sterility: No growth
• ⚠️ Note: Utility focuses on specific challenges of alpha therapy: chelate stability under nuclear recoil and control of long-lived impurities that may create unacceptable long-term radiation dose.

4. URS — user requirements

5. input.csv contract

BatchNumber,Radiopharmaceutical,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_mg_Ab,Long_Lived_Th_Impurities_Percent,Free_Thorium_Ion_Percent,Daughter_Nuclide_Escape_Percent,pH_Value,Protein_Concentration_mg_per_mL,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
TH227-AB-2026-001,Th-227-DOTA-Anti-HER2,99.9,98.0,5.0,0.05,1.5,5.0,6.5,2.0,0,5.0,0,0,0,0,0

6. FS — functional specification

7. output.json example

{
  "utilityId": "thorium227-quality-checker",
  "api": "Thorium-227",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TH227-AB-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiopharmaceutical",
      "value": "Th-227-DOTA-Anti-HER2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radionuclidic_Purity_Percent",
      "value": "99.9",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiochemical_Purity_Percent",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Specific_Activity_MBq_mg_Ab",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Long_Lived_Th_Impurities_Percent",
      "value": "0.05",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Free_Thorium_Ion_Percent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Daughter_Nuclide_Escape_Percent",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

8. OQ/PQ test scenarios

9. QA/QC and change control

• Do not rename columns without validator update.
• Store input.csv, output.json, executable version and checksum.
• Before production use perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical radiopharmaceutical limits must be checked against the approved specification and local SOPs.