Lutetium177J591QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Lutetium177J591QualityChecker for Lutetium-177 J591.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Lutetium-177 J591:
• • Radionuclidic purity (≥99.9%)
• • Lutetium-177m impurity (≤0.01%)
• • Radiochemical purity (≥95%) — binding to J591 monoclonal antibody
• • Free lutetium (≤5%)
• • Antibody aggregates (≤5%)
• • pH (6.5–7.5), endotoxins, sterility
• ⚠️ CRITICAL: Aggregates >5% → risk of immunogenicity and rapid clearance from blood!
• Free lutetium >5% → accumulation in bone marrow (myelotoxicity)!
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Lutetium177mImpurityPercent,RadiochemicalPurityPercent,FreeLutetiumPercent,AggregateContentPercent,ProteinConcentrationMgPerMl,pH,EndotoxinsEU,SterilityTest,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — Lutetium must be firmly chelated (usually DOTA or DTPA conjugated to the antibody). Free lutetium accumulates in bones.
• • Aggregates ≤5% — Aggregated antibodies are rapidly cleared by the reticuloendothelial system (liver/spleen) and can cause anaphylactic reactions. Control by SEC-HPLC is mandatory.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Lutetium177mImpurityPercent,RadiochemicalPurityPercent,FreeLutetiumPercent,AggregateContentPercent,ProteinConcentrationMgPerMl,pH,EndotoxinsEU,SterilityTest,ProductType
Lu177-J591-2026-001,3700.0,99.98,0.005,98.5,1.0,1.5,2.0,7.0,30.0,0,Therapeutic
Lu177-J591-2026-002,3500.0,99.85,0.02,94.0,6.5,6.0,2.1,6.8,180.0,0,Therapeutic
Lu177-J591-2026-003,3800.0,99.99,0.002,99.0,0.5,0.8,1.9,7.2,20.0,0,Therapeutic

FS — Functional Specification

Example output.json

{
  "utilityId": "lutetium177-j591-quality-checker",
  "api": "Lutetium-177 J591",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "Lu177-J591-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "3700.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.98",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Lutetium177mImpurityPercent",
      "value": "0.005",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeLutetiumPercent",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "AggregateContentPercent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ProteinConcentrationMgPerMl",
      "value": "2.0",
      "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.