Scandium47QualityChecker

1. Scope

This document defines requirements and functional behaviour for Scandium47QualityChecker used to control: Scandium-47. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• Scandium47QualityChecker.exe — demo mode or help output.
• Scandium47QualityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Scandium-47 Quality Checker — Theranostic Radiopharmaceutical (Ph. Eur., USP)
• ℹ️ The utility checks RCP, free scandium, long-lived impurities (Sc-46), sterility.
• ⚠️ CRITICAL! Free Sc ≤5%. Sc-46 impurities ≤0.1%. Sterility mandatory!
• BatchNumber,Radiopharmaceutical,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_nmol,Free_Scandium_Ion_Percent,Long_Lived_Impurities_Percent,Target_Metal_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
• • Radiochemical Purity: Free Sc³⁺ ion has high affinity for plasma proteins and accumulates in the liver. RCP must be ≥95%.
• • Sterility and Endotoxins: Drug is administered intravenously. Requirements are strict.
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.0%
• • Radiochemical Purity: ≥ 95.0%
• • Free Scandium: ≤ 5.0%
• • Long-Lived Impurities (Sc-46): ≤ 0.1%
• • Specific Activity: ≥ 10 MBq/nmol
• • pH: 4.5–7.5
• • Endotoxins: ≤ 17.5 EU/mL
• • Sterility: No growth
• ⚠️ Note: Utility focuses on controlling specific Sc-47 production impurities (especially Sc-46) and free metal ions, which affect biodistribution and dosimetry.

4. URS — user requirements

5. input.csv contract

BatchNumber,Radiopharmaceutical,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_nmol,Free_Scandium_Ion_Percent,Long_Lived_Impurities_Percent,Target_Metal_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
SC47-DOTA-2026-001,Sc-47-DOTATATE,99.9,98.5,50.0,1.0,0.05,2.0,6.5,5.0,0,5.0,0,0,0,0,0

6. FS — functional specification

7. output.json example

{
  "utilityId": "scandium47-quality-checker",
  "api": "Scandium-47",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "SC47-DOTA-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiopharmaceutical",
      "value": "Sc-47-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": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Free_Scandium_Ion_Percent",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Long_Lived_Impurities_Percent",
      "value": "0.05",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Target_Metal_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.