Zirconium89DFOQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Zirconium89DFOQualityChecker for Zirconium-89 DFO.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Zr-89-DFO:
• • Radionuclidic purity (≥99.0%)
• • Yttrium-88 impurity (≤0.001%) — CRITICAL!
• • Yttrium-87 impurity (≤0.1%)
• • Radiochemical purity (≥95%, DFO complex)
• • Free zirconium (≤5%) — BONE ACCUMULATION!
• • Specific activity, pH, endotoxins, sterility
• ⚠️ CRITICAL: Free zirconium (Zr4+) has high affinity for bone tissue.
• Y-88 impurity creates long-term radioactive waste issues.
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Yttrium88ImpurityPercent,Yttrium87ImpurityPercent,RadiochemicalPurityPercent,FreeZirconiumPercent,pH,EndotoxinsEU,SterilityTest,SpecificActivityGBqPerUmol,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — Zr-DFO complex must be stable in vivo. Instability leads to Zr4+ release.
• • Free zirconium ≤5% — Zr4+ ion has extremely high affinity for bone hydroxyapatite. Even small amounts of free zirconium lead to intense skeletal accumulation, masking bone metastases and increasing bone marrow dose.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Yttrium88ImpurityPercent,Yttrium87ImpurityPercent,RadiochemicalPurityPercent,FreeZirconiumPercent,pH,EndotoxinsEU,SterilityTest,SpecificActivityGBqPerUmol,ProductType
ZR89-DFO-2026-001,150.0,99.8,0.0005,0.05,98.5,1.5,7.0,20.0,0,150.0,ImmunoPET
ZR89-DFO-FAIL-002,140.0,98.0,0.01,0.5,90.0,10.0,6.5,30.0,0,40.0,ImmunoPET
ZR89-DFO-BONE-003,145.0,99.5,0.0008,0.1,96.0,8.0,7.2,15.0,0,120.0,ImmunoPET

FS — Functional Specification

Example output.json

{
  "utilityId": "zirconium89-dfo-quality-checker",
  "api": "Zirconium-89 DFO",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ZR89-DFO-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "150.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Yttrium88ImpurityPercent",
      "value": "0.0005",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Yttrium87ImpurityPercent",
      "value": "0.05",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeZirconiumPercent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "7.0",
      "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.