Terbium149QualityChecker

1. Scope

This document defines requirements and functional behaviour for Terbium149QualityChecker used to control: Terbium-149. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• Terbium149QualityChecker.exe — demo mode or help output.
• Terbium149QualityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Terbium-149 Quality Checker — Alpha Theranostics (Ph. Eur., USP)
• ⚠️ CRITICAL! Tb-155/156 impurities ≤1.0%. Free Tb ≤5%. SA ≥100 MBq/nmol!
• BatchNumber,Radiopharmaceutical,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_nmol,Long_Lived_Tb_Impurities_Percent,Free_Terbium_Ion_Percent,Target_Material_Residue_ppm,pH_Value,Ethanol_Content_Percent,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
• Terbium-149 — unique alpha-emitter for theranostics (T1/2 = 4.1 h):
• • Long-Lived Impurities: Accelerator production often yields Tb-155 and Tb-156 (T1/2 ~5.3 days). Their presence increases patient dose without therapeutic benefit. Limit is strict (≤1.0%).
• • Radiochemical Purity: Free Tb³⁺ ion accumulates in bones and liver. For alpha therapy, this is critical due to high LET. RCP must be ≥95%.
• • Specific Activity: Must be high (≥100 MBq/nmol) for efficient receptor saturation with low mass.
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.0%
• • Radiochemical Purity: ≥ 95.0%
• • Long-Lived Impurities (Tb-155/156): ≤ 1.0%
• • Free Terbium: ≤ 5.0%
• • Specific Activity: ≥ 100 MBq/nmol
• • pH: 4.5–7.5
• • Endotoxins: ≤ 17.5 EU/mL
• • Sterility: No growth
• ⚠️ Note: Utility focuses on specific accelerator-produced impurities of Tb-149 and free ion control, which is critical for alpha therapy safety.

4. URS — user requirements

5. input.csv contract

BatchNumber,Radiopharmaceutical,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_nmol,Long_Lived_Tb_Impurities_Percent,Free_Terbium_Ion_Percent,Target_Material_Residue_ppm,pH_Value,Ethanol_Content_Percent,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
TB149-DOTA-2026-001,Tb-149-DOTATATE,99.5,98.0,200.0,0.4,1.5,5.0,6.5,5.0,0,5.0,0,0,0,0,0

6. FS — functional specification

7. output.json example

{
  "utilityId": "terbium149-quality-checker",
  "api": "Terbium-149",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TB149-DOTA-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiopharmaceutical",
      "value": "Tb-149-DOTATATE",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radionuclidic_Purity_Percent",
      "value": "99.5",
      "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_nmol",
      "value": "200.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Long_Lived_Tb_Impurities_Percent",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Free_Terbium_Ion_Percent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Target_Material_Residue_ppm",
      "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.