Y90MicrosphereRadioembolizationChecker

Y-90 Microsphere Radioembolization Checker

api radiopharmaceuticals nuclear-medicine y-90 radioembolization microspheres liver-tumours
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Y-90 Microsphere Radioembolization Checker — Quality control of Y-90 microspheres for SIRT

ℹ️ Utility checks critical parameters of Y-90 microspheres:

  • Particle size (10-60 μm) and D90 (<70 μm)
  • Radiochemical purity (≥99%)
  • Free yttrium (<0.1%)
  • Lung shunt fraction (<15%) — CRITICAL!

⚠️ CRITICAL: Lung shunting >15% is contraindication for procedure!

Y-90 microspheres are used for selective internal radiation therapy (SIRT) of liver.

Free Y-90 accumulates in bones, causing severe myelosuppression.

Usage

Y90MicrosphereRadioembolizationChecker.exe → demo mode (console output)

Y90MicrosphereRadioembolizationChecker.exe input.csv output.json → evaluate your data

Input format

BatchNumber,MicrosphereType,MeanParticleSizeUm,ParticleSizeD90Um,PolydispersityIndex,RadiochemicalPurityPercent,FreeYttriumPercent,ActivityGBq,SpecificActivityGBq_per_g,pH,SterilityTest,EndotoxinsEU_per_mL,LungShuntFraction

Example

Y90-GLASS-2026-001,Glass,30.0,40.0,0.1,99.9,0.01,5.0,2500.0,7.0,0,5.0,3.0

— WHY IS THIS NEEDED?

Y-90 microspheres (glass or resin) are drug for treating inoperable liver tumors.

  • Mechanism: embolization of tumor capillaries + local beta irradiation.
  • Particle size is critical: they must lodge in precapillaries but not in major vessels.
  • Free Y-90 is toxic to bone marrow.
  • Lung shunting (LSF) determines procedure eligibility.

⚠️ CRITICAL:

  • Particle size 10-60 μm — optimal range for capillary embolization.
  • D90 <70 μm — guarantee of absence of large aggregates.
  • Radiochemical purity ≥99% — minimization of free yttrium.
  • Free yttrium <0.1% — prevention of myelosuppression.
  • Lung shunt fraction (LSF) <15% — safety limit for lungs.
  • pH 6.0-8.0 — physiological range.
  • Endotoxins <175 EU/mL — standard for intravascular drugs.
  • Sterility — MANDATORY.

Key features

  • Strict control of lung shunt fraction (LSF).
  • Assessment of particle size and polydispersity.
  • Radiochemical purity and free yttrium check.
  • Support for both microsphere types (Glass/Resin).
  • Compliance with GMP requirements for radioembolization.

Critical parameters

  • Particle size: 10–60 μm
  • D90: <70 μm
  • PDI: <0.2
  • Radiochemical purity: ≥99.0%
  • Free yttrium: <0.1%
  • Lung shunt fraction (LSF): <15.0%
  • pH: 6.0–8.0
  • Endotoxins: <175 EU/mL
  • Sterility: no growth

💡 Usage tips:

1. Particle size determined by laser diffraction or microscopy.

2. LSF measured before procedure using Tc-99m MAA (macroaggregated albumin).

3. Drug requires special beta radiation protection measures during handling.

4. Glass microspheres have higher specific activity than resin ones.

5. Procedure performed by interventional radiologist under angiography control.

⚠️ Note: Y-90 radioembolization is complex hybrid procedure combining surgery and radiotherapy. Microsphere quality directly affects patient survival. This utility serves as final safety barrier before drug administration into hepatic artery.

input.csv

BatchNumber,MicrosphereType,MeanParticleSizeUm,ParticleSizeD90Um,PolydispersityIndex,RadiochemicalPurityPercent,FreeYttriumPercent,ActivityGBq,SpecificActivityGBq_per_g,pH,SterilityTest,EndotoxinsEU_per_mL,LungShuntFraction
Y90-GLASS-2026-001,Glass,30.0,40.0,0.1,99.9,0.01,5.0,2500.0,7.0,0,5.0,3.0
Y90-RESIN-2026-002,Resin,35.0,50.0,0.15,99.5,0.05,4.5,2000.0,6.5,0,10.0,8.0
Y90-GLASS-2026-003,Glass,25.0,35.0,0.1,99.8,0.02,6.0,3000.0,7.2,0,5.0,20.0

URS & FS — user requirements and functional specification

URS — User Requirements Specification

  • The utility shall accept input.csv with these mandatory columns: BatchNumber, MicrosphereType, MeanParticleSizeUm, ParticleSizeD90Um, PolydispersityIndex, RadiochemicalPurityPercent, FreeYttriumPercent, ActivityGBq, SpecificActivityGBq_per_g, pH, SterilityTest, EndotoxinsEU_per_mL, LungShuntFraction.
  • Each row shall be processed as a separate batch or record identified by BatchNumber.
  • Before evaluation, the utility shall validate the CSV structure, mandatory values, numeric fields and allowed text values.
  • Rules and limits shall be applied to every parameter in the input row.
  • Critical violations identified in the supplied description shall set the record result to FAIL.
  • Each row shall receive an overall PASS, WARNING or FAIL status with the triggered rules.
  • An invalid row shall not receive PASS.
  • output.json shall contain source values, applied limits, individual check results and errors.
  • The same input and the same rule profile shall produce the same result.

FS — Functional Specification

  1. Run Y90MicrosphereRadioembolizationChecker.exe in demonstration mode or with input.csv output.json arguments.
  2. Read UTF-8 CSV and verify the exact set of mandatory columns.
  3. Convert row values to numeric and text types.
  4. Apply the rules defined in the approved version or configuration profile.
  5. Generate individual check results and derive the overall status from the most severe violation.
  6. Write machine-readable output.json.
  7. Structural and type errors shall be reported explicitly and shall not be masked by a successful status.

Complete input.csv example

BatchNumber,MicrosphereType,MeanParticleSizeUm,ParticleSizeD90Um,PolydispersityIndex,RadiochemicalPurityPercent,FreeYttriumPercent,ActivityGBq,SpecificActivityGBq_per_g,pH,SterilityTest,EndotoxinsEU_per_mL,LungShuntFraction
Y90-GLASS-2026-001,Glass,30.0,40.0,0.1,99.9,0.01,5.0,2500.0,7.0,0,5.0,3.0
Y90-RESIN-2026-002,Resin,35.0,50.0,0.15,99.5,0.05,4.5,2000.0,6.5,0,10.0,8.0
Y90-GLASS-2026-003,Glass,25.0,35.0,0.1,99.8,0.02,6.0,3000.0,7.2,0,5.0,20.0

Purpose of the supplied test rows

  • The first row contains values consistent with the criteria stated in the supplied description.
  • The second row contains values closer to the limits or moderate deviations.
  • The third row contains clear deviations for negative-result testing.

Minimum output.json structure

{
  "utility": "Y90MicrosphereRadioembolizationChecker",
  "source": "input.csv",
  "results": [
    {
      "batchNumber": "BATCH-001",
      "status": "PASS",
      "checks": [
        {
          "parameter": "ParameterName",
          "value": 0,
          "limit": "configured rule",
          "status": "PASS"
        }
      ],
      "errors": []
    }
  ]
}

Minimum OQ scenarios

  • Process the complete supplied input.csv.
  • Remove a mandatory column and confirm a contract error.
  • Provide text instead of a numeric value and confirm a type error.
  • Test values directly on the configured limits.
  • Repeat the run with the same input and confirm an identical result.

Before operational use

  • Reconcile rules and limits with the approved specification, methods and SOP.
  • Fix the executable version and rule-profile version.
  • Retain the source CSV together with the generated JSON.

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