Copper64QualityChecker

1. Scope

This document defines requirements and functional behaviour for Copper64QualityChecker used to control: Copper-64. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• Copper64QualityChecker.exe — demo mode or help output.
• Copper64QualityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Copper-64 Quality Checker — Radiopharmaceutical (Ph. Eur., USP)
• ℹ️ The utility checks radiochemical purity, specific activity, Ni/Zn impurities, sterility, endotoxins.
• ⚠️ CRITICAL! RCP ≥95%. Specific Activity ≥10 GBq/umol. Ni ≤5 ppm. Sterility mandatory!
• BatchNumber,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_GBq_umol,Nickel_Content_ppm,Zinc_Content_ppm,Iron_Content_ppm,Total_Metal_Impurities_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 (RCP): Critical. Free copper ($^{64}\text{Cu}^{2+}$) accumulates in liver and kidneys, creating background and toxicity. RCP must be ≥95%.
• • Chemical Impurities (Ni, Zn): Nickel (target material) and Zinc (decay product) compete with copper for the chelator (DOTA, NOTA, SAR). Their content must be minimal (Ni ≤5 ppm).
• • Sterility and Endotoxins: Drug is administered intravenously. Requirements are strict.
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.0%
• • Radiochemical Purity: ≥ 95.0%
• • Specific Activity: ≥ 10.0 GBq/umol (depends on ligand)
• • Nickel: ≤ 5.0 ppm
• • Zinc: ≤ 10.0 ppm
• • Iron: ≤ 5.0 ppm
• • pH: 4.5–7.5
• • Endotoxins: ≤ 17.5 EU/mL (or per dose)
• • Sterility: No growth
• ⚠️ Note: Utility adapted for radiopharmaceutical specifics: control of chelation competitors (Ni, Zn) and specific activity. Analysis time is limited by half-life (12.7 h).

4. URS — user requirements

5. input.csv contract

BatchNumber,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_GBq_umol,Nickel_Content_ppm,Zinc_Content_ppm,Iron_Content_ppm,Total_Metal_Impurities_ppm,pH_Value,Ethanol_Content_Percent,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
CU64-RAD-2026-001,99.9,98.5,50.0,1.5,2.0,0.5,4.0,6.5,5.0,0,5.0,0,0,0,0,0

6. FS — functional specification

7. output.json example

{
  "utilityId": "copper64-quality-checker",
  "api": "Copper-64",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "CU64-RAD-2026-001",
      "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_GBq_umol",
      "value": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Nickel_Content_ppm",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Zinc_Content_ppm",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Iron_Content_ppm",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Total_Metal_Impurities_ppm",
      "value": "4.0",
      "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.