Gallium68HBEDCCQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Gallium68HBEDCCQualityChecker for Gallium-68 HBED-CC.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of [68Ga]Ga-PSMA-11 (HBED-CC):
• • Radionuclidic purity (≥99.9%)
• • Radiochemical purity (≥95%)
• • Free Gallium-68 impurity (≤5.0%)
• • Precursor/Cold ligand impurity (≤2.0%)
• • Specific activity (≥20 GBq/μmol)
• • Residual solvents (ethanol), pH, endotoxins, sterility
• ⚠️ CRITICAL: Free Gallium-68 >5.0% → accumulation in liver and bones, risk of false positives!
• Germanium-68 (Ge-68) breakthrough from generator must be minimal (<0.001%).
• BatchNumber,RadionuclidicPurityPercent,RadiochemicalPurityPercent,FreeGalliumPercent,PrecursorImpurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ResidualEthanolPercent,SpecificActivityGBqPerUmol
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — ensures specific accumulation in prostate tumor cells
• • Free Gallium ≤5.0% — [68Ga]Ga3+ hydrolyzes and accumulates in liver, spleen, and bones, creating high background and masking metastases

URS — User Requirements Specification

input.csv contract

BatchNumber,RadionuclidicPurityPercent,RadiochemicalPurityPercent,FreeGalliumPercent,PrecursorImpurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ResidualEthanolPercent,SpecificActivityGBqPerUmol
GA68-PSMA-2026-001,99.99,98.5,1.0,0.5,5.5,20.0,0,1,5.0,40.0
GA68-PSMA-2026-002,99.95,94.0,6.5,1.0,6.8,100.0,0,5,8.0,15.0
GA68-PSMA-2026-003,99.98,99.0,0.5,0.2,5.0,10.0,0,1,2.0,60.0

FS — Functional Specification

Example output.json

{
  "utilityId": "gallium68-hbedcc-quality-checker",
  "api": "Gallium-68 HBED-CC",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "GA68-PSMA-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.99",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeGalliumPercent",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "PrecursorImpurityPercent",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "5.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "20.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SterilityTest",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator and test set.
• Retain 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 verified against the approved specification and local SOPs.