Y90MicrosphereRadioembolizationChecker
Y-90 Microsphere Radioembolization Checker
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.csvwith 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.jsonshall 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
- Run
Y90MicrosphereRadioembolizationChecker.exein demonstration mode or withinput.csv output.jsonarguments. - Read UTF-8 CSV and verify the exact set of mandatory columns.
- Convert row values to numeric and text types.
- Apply the rules defined in the approved version or configuration profile.
- Generate individual check results and derive the overall status from the most severe violation.
- Write machine-readable
output.json. - 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.
Included in packages
PetRad QC Suite
A specialised utility package for radiopharmaceutical quality control: PET, SPECT, therapeutic radionuclides, generators and decay calculations.
OpenPetRad3: expanded PET/SPECT and radiopharmaceutical QC package
A curated suite for PET/SPECT radiopharmaceuticals, generator and cyclotron radionuclides, labelled compounds, radiochemical purity, breakthrough, sterility and endotoxin control.
OpenRadioligand & Theranostics Expansion QC Suite
Radioligand & Theranostics Expansion QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.
OpenRadiopharmaceutical Diagnostics and Therapy QC Suite
36 utilities for clinically oriented radiopharmaceutical and workflow quality control: PET/SPECT tracers, the Tc-99m renal workflow, PRRT, PSMA therapy, targeted alpha therapy, radioembolization, bone-pain palliation, immuno-PET and generator-based radionuclide control.
OpenRPH isotope family: beta-emitting therapy
Lu-177, Y-90, Ho-166, Re-188, Sm-153, Sr-89, P-32, Cu-67 and Tb-161.
OpenRPH organ/system: bone and musculoskeletal
Bone scintigraphy, MDP/PYP, marrow, bone-pain palliation, skeletal metastases and radiosynovectomy.
OpenRPH organ/system: hepatobiliary and GI
HIDA, mebrofenin, gallbladder, gastric emptying, GI transit, bleeding and liver/spleen imaging.
OpenRPH organ/system: oncology and theranostics
Tumour imaging, PSMA/FAPI/receptor tracers, immuno-PET, targeted radionuclide therapy and radioembolization.
OpenRPH organ/system: pulmonary and ventilation
Lung perfusion, MAA, V/Q, aerosol, xenon ventilation, shunt and pulmonary dosimetry.
OpenRPH use case: radionuclide therapy and theranostics
Lu-177, Ac-225, Ra-223, Y-90, Ho-166, Sm-153, Sr-89, Re-188, Tb-161, I-131 and other therapeutic radiopharmaceuticals: activity, purity, free metal, daughters and toxicological constraints.
OpenRPH workflow: dosimetry and therapy planning
Activity planning, absorbed dose, organ dose, lung shunt, preplanning and therapy verification.
OpenRPH workflow: product release QC
Assay, purity, sterility, endotoxins, pH, impurities, appearance and batch-release checks.
OpenRPH: combined radiopharmaceutical QC package
RPH combines PetRad, PetRad2 and PetRad3 into one umbrella package for PET/SPECT, therapeutic radionuclides, generators, labelled compounds, decay calculations, sterility, endotoxins and radiochemical/radionuclidic purity.
Open