Terbium155QualityChecker

1. Scope

This document defines requirements and functional behaviour for Terbium155QualityChecker used to control: Terbium-155. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• Terbium155QualityChecker.exe — demo mode or help output.
• Terbium155QualityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Terbium-155 Quality Checker — SPECT Diagnostics (Ph. Eur., USP)
• ⚠️ CRITICAL! Other Tb isotopes ≤1.0%. Free Tb ≤5%. SA ≥50 MBq/nmol!
• BatchNumber,Radiopharmaceutical,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_nmol,Other_Tb_Isotopes_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
• • Other Tb Isotopes: Accelerator production may yield Tb-149 (alpha), Tb-152 (PET), Tb-156 (beta). Their presence creates unnecessary dose and image background. Limit is strict (≤1.0%).
• • Radiochemical Purity: Free Tb³⁺ ion accumulates in bones and liver, creating background on SPECT images and increasing dose. RCP must be ≥95%.
• • Specific Activity: Must be high (≥50 MBq/nmol) for high-quality SPECT images with high contrast.
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.0%
• • Radiochemical Purity: ≥ 95.0%
• • Other Tb Isotopes: ≤ 1.0%
• • Free Terbium: ≤ 5.0%
• • Specific Activity: ≥ 50 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-155 and free ion control, which is critical for SPECT image quality and patient safety.

4. URS — user requirements

5. input.csv contract

BatchNumber,Radiopharmaceutical,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_nmol,Other_Tb_Isotopes_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
TB155-DOTA-2026-001,Tb-155-DOTATATE,99.9,98.5,120.0,0.05,1.0,2.0,6.5,5.0,0,5.0,0,0,0,0,0

6. FS — functional specification

7. output.json example

{
  "utilityId": "terbium155-quality-checker",
  "api": "Terbium-155",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TB155-DOTA-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiopharmaceutical",
      "value": "Tb-155-DOTATATE",
      "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": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Specific_Activity_MBq_nmol",
      "value": "120.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Other_Tb_Isotopes_Percent",
      "value": "0.05",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Free_Terbium_Ion_Percent",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Target_Material_Residue_ppm",
      "value": "2.0",
      "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.