Yttrium90GlassMicrosphereChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Yttrium90GlassMicrosphereChecker for Yttrium-90 Glass Microsphere.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Y-90 Glass Microspheres:
• • Sphericity (≥95%)
• • Absence of free Y-90 (<0.1%)
• • Y-88 impurity (≤0.001%)
• • pH, endotoxins, sterility
• ⚠️ CRITICAL: Glass microspheres have HIGH specific activity.
• Particle size is critical to prevent lung shunting.
• BatchNumber,TotalActivityGBq,ActivityPerSphereBq,MeanDiameterMicrons,DiameterRangeMinMicrons,DiameterRangeMaxMicrons,SphericityPercent,RadionuclidicPurityPercent,Yttrium88ImpurityPercent,FreeYttriumPercent,pH,EndotoxinsEU,SterilityTest,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Sphericity ≥95% — Ensures laminar flow during injection through microcatheter and prevents clogging.
• • Absence of free Y-90 (<0.1%) — Unlike resins where Y-90 is adsorbed on surface, in glass it is integrated. Leaching must be minimal. Free Y-90 is toxic to bone marrow.
• • Y-88 impurity ≤0.001% — Long-lived impurity creating waste and dose burden issues.
• • pH 4.0–7.5, Endotoxins ≤175 EU/vial, Sterility — standard safety requirements.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityGBq,ActivityPerSphereBq,MeanDiameterMicrons,DiameterRangeMinMicrons,DiameterRangeMaxMicrons,SphericityPercent,RadionuclidicPurityPercent,Yttrium88ImpurityPercent,FreeYttriumPercent,pH,EndotoxinsEU,SterilityTest,ProductType
Y90-GLASS-2026-001,20.0,2500.0,25.0,20.0,30.0,99.0,99.99,0.0005,0.01,6.0,10.0,0,GlassMicrospheres
Y90-GLASS-FAIL-002,18.0,2400.0,35.0,30.0,40.0,98.0,99.9,0.001,0.05,6.5,15.0,0,GlassMicrospheres
Y90-GLASS-LEACH-003,19.0,2450.0,25.0,20.0,30.0,99.0,99.95,0.0008,0.5,6.0,10.0,0,GlassMicrospheres

FS — Functional Specification

Example output.json

{
  "utilityId": "yttrium90-glass-microsphere-checker",
  "api": "Yttrium-90 Glass Microsphere",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "Y90-GLASS-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityGBq",
      "value": "20.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ActivityPerSphereBq",
      "value": "2500.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "MeanDiameterMicrons",
      "value": "25.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "DiameterRangeMinMicrons",
      "value": "20.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "DiameterRangeMaxMicrons",
      "value": "30.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SphericityPercent",
      "value": "99.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.99",
      "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.