Yttrium90ResinMicrosphereChecker

Utility description: Yttrium-90 Resin Microsphere

Yttrium-90 Resin Microsphere Quality Checker — Yttrium-90 Resin Microspheres (SIR-Spheres)

ℹ️  Utility checks critical parameters of Y-90 Resin Microspheres:
    • Particle size (20–60 μm)
    • Number of particles (important for dosimetry)
    • Sphericity (≥90%)
    • Absence of free Y-90 (<0.5%)
    • Y-88 impurity (≤0.001%)
    • pH, endotoxins, sterility

⚠️  CRITICAL: Resin microspheres have LOW specific activity.
    Y-90 is adsorbed on the surface. Leaching risk is higher than glass.
    Dosing is often calculated based on particle count and body surface area (BSA).

Usage:
  Yttrium90ResinMicrosphereChecker.exe                            → demo mode (console output)
  Yttrium90ResinMicrosphereChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,TotalActivityGBq,NumberOfParticlesMillions,MeanDiameterMicrons,DiameterRangeMinMicrons,DiameterRangeMaxMicrons,SphericityPercent,RadionuclidicPurityPercent,Yttrium88ImpurityPercent,FreeYttriumPercent,pH,EndotoxinsEU,SterilityTest,ProductType

Example (sterility: 0=sterile, 1=contaminated):
  Y90-RESIN-2026-001,3.0,60.0,35.0,20.0,60.0,95.0,99.95,0.0005,0.1,5.5,20.0,0,ResinMicrospheres

Supported product types:
• ResinMicrospheres — resin microspheres (SIR-Spheres®)

— WHY IS THIS NEEDED?
Y-90 Resin Microspheres (e.g., SIR-Spheres®) are used for liver radioembolization:
• Y-90 is chemically bound (adsorbed/chelated) to the surface of acrylic resin.
• Low specific activity (~50 Bq per particle). A large number of particles (40-80 million) is required to deliver therapeutic dose.
• Particles have a wider size range (20-60 μm) and less perfect sphericity compared to glass.
• Used for treating hepatocellular carcinoma (HCC) and liver metastases.
• Dosimetry is often based on BSA (Body Surface Area) model or compartmental model.

⚠️  CRITICAL:
• Particle size 20–60 μm — Control is necessary to prevent lung shunting and ensure occlusion of tumor vessels.
• Number of particles — Key parameter for resin microspheres. Excess particles can lead to mechanical occlusion of healthy vessels (unwanted embolization), while insufficient count leads to inadequate activity delivery.
• Sphericity ≥90% — Important for passage through microcatheter. Resin is less rigid and less spherical than glass.
• Absence of free Y-90 (<0.5%) — Since Y-90 is on the surface, it can leach into the bloodstream. Free Y-90 accumulates in bones and bone marrow, causing toxicity. Limit is stricter than some other drugs but looser than glass.
• Y-88 impurity ≤0.001% — Long-lived impurity.
• pH 4.0–7.5, Endotoxins ≤175 EU/vial, Sterility — standard safety requirements.

Key features:
• Specific control of particle count (Number of Particles)
• Assessment of low specific activity
• Control of Y-90 leaching from resin surface
• Support for parameters specific to SIR-Spheres

Critical parameters:
• Particle size: 20–60 μm (mean)
• Number of particles: Typically 40-80 million per dose
• Sphericity: ≥90.0%
• Free Y-90: ≤0.5% (leaching)
• Y-88 impurity: ≤0.001%
• Radionuclidic purity: ≥99.9%
• pH: 4.0–7.5
• Endotoxins: ≤175 EU/vial
• Sterility: no microbial growth

💡 Usage tips:
1. Resin microspheres may swell in aqueous media.
2. Due to low specific activity, dose calculation often requires accounting for particle count to avoid excessive embolization of healthy liver tissue.
3. Leaching control is performed by measuring supernatant activity.
4. When handling Y-90 resin, consider the possibility of reflux due to lower density and rigidity of particles compared to glass.

⚠️ Note: Y-90 Resin Microspheres require larger injection volume and higher particle count to achieve the same activity as glass. This creates a risk of mechanical embolization of healthy vessels if particle count limits are not observed. Y-90 leaching is a more significant risk compared to glass microspheres.