Indium111WBCLabelingChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Indium111WBCLabelingChecker for Indium-111 WBC Labeling.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of autologous leukocytes labeled with Indium-111:
• • Labeling efficiency (≥80%)
• • Free Indium-111 impurity (≤20%)
• • Cell viability (≥95%)
• • pH (7.0–7.4), endotoxins, sterility, hemoglobin contamination
• ⚠️ CRITICAL: Low viability (<95%) indicates cell damage during isolation!
• BatchNumber,LabelingEfficiencyPercent,FreeIndium111Percent,CellViabilityPercent,WBCCountMillion,pH,EndotoxinsEU,SterilityTest,HemoglobinContaminationMgPerDl,IncubationTimeMinutes,AnticoagulantType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Labeling efficiency ≥80% — ensures sufficient signal at the infection site.
• • Free Indium-111 ≤20% — unbound indium binds to plasma transferrin, accumulating in liver, spleen, and bone marrow, masking pathology.
• • Viability ≥95% — dead cells do not migrate and may release the isotope.
• • Sterility — MANDATORY, as the product is injected intravenously.
• • Hemoglobin contamination ≤50 mg/dL — indicator of WBC fraction purity from RBCs.

URS — User Requirements Specification

input.csv contract

BatchNumber,LabelingEfficiencyPercent,FreeIndium111Percent,CellViabilityPercent,WBCCountMillion,pH,EndotoxinsEU,SterilityTest,HemoglobinContaminationMgPerDl,IncubationTimeMinutes,AnticoagulantType
IN111-WBC-2026-001,92.0,8.0,98.0,50.0,7.2,50.0,0,10.0,30,ACD
IN111-WBC-2026-002,75.0,25.0,90.0,45.0,7.0,60.0,0,15.0,25,Heparin

FS — Functional Specification

Example output.json

{
  "utilityId": "indium111-wbc-labeling-checker",
  "api": "Indium-111 WBC Labeling",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "IN111-WBC-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "LabelingEfficiencyPercent",
      "value": "92.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeIndium111Percent",
      "value": "8.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "CellViabilityPercent",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "WBCCountMillion",
      "value": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "7.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "50.0",
      "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.