Ho166MicrosphereQualityChecker

Ho-166 Microsphere Quality Checker

api radiopharmaceuticals nuclear-medicine ho-166 radioembolization microspheres liver-tumours

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Ho-166 Microsphere Quality Checker — Quality control of Ho-166 microspheres for radioembolization

ℹ️ Utility checks critical parameters of Ho-166 microspheres:

Radiochemical purity (≥98%)
Free holmium (≤2%)
Particle size (20-50 μm) and D90 (<60 μm)
Specific activity (≥1000 MBq/mg)
Ho-166m impurity, pH, endotoxins, sterility

⚠️ CRITICAL: Incorrect particle size leads to lung shunting!

Ho-166 is used for liver radioembolization (SIRT).

Free holmium is toxic and accumulates in bones.

Usage

Ho166MicrosphereQualityChecker.exe → demo mode (console output)

Ho166MicrosphereQualityChecker.exe input.csv output.json → evaluate your data

Input format

BatchNumber,RadiochemicalPurityPercent,FreeHolmiumPercent,ParticleSizeMeanUm,ParticleSizeD90Um,SpecificActivityMBq_per_mg,pH,EndotoxinsEU_per_mL,SterilityTest,ActivityGBq,RadionuclidicPurityPercent,Ho166mImpurityPercent

Example

HO166-MS-2026-001,99.0,0.5,25.0,35.0,3000.0,7.0,10.0,0,6.0,99.99,0.0005

— WHY IS THIS NEEDED?

Ho-166 microspheres (e.g., QuiremSpheres) are used for selective internal radiation therapy (SIRT) of liver.

Microspheres lodge in tumor capillaries, delivering high beta radiation dose.
Ho-166 has 26.8-hour half-life and emits high-energy beta particles.
Also emits gamma quanta, allowing post-therapeutic imaging (SPECT/CT).
Particle size is critical: too small pass to lungs (shunt), too large block major vessels.

⚠️ CRITICAL:

Radiochemical purity ≥98% — guarantee that emitter stays in tumor.
Free holmium ≤2% — free ions are toxic and accumulate in bones and GI tract.
Particle size 20-50 μm — optimal range for capillary embolization.
D90 < 60 μm — ensures absence of large aggregates.
Specific activity ≥1000 MBq/mg — necessary for therapeutic effect.
Ho-166m impurity < 0.01% — Ho-166m has different decay spectrum and may distort dosimetry.
pH 6.0-8.0 — for biocompatibility.
Endotoxins <175 EU/mL — standard for intravascular drugs.
Sterility — MANDATORY.

Key features

Strict control of particle size (Mean and D90).
Assessment of free holmium content, critical for safety.
Specific activity check for effective therapy.
Control of Ho-166m impurity formed during reactor activation.
Compliance with GMP requirements for radioembolization drugs.

Critical parameters

Radiochemical purity: ≥98.0%
Free holmium: ≤2.0%
Particle size (Mean): 20–50 μm
Particle size (D90): <60 μm
Specific activity: ≥1000 MBq/mg
Radionuclidic purity: ≥99.9%
Ho-166m impurity: <0.01%
pH: 6.0–8.0
Endotoxins: <175 EU/mL
Sterility: no growth

💡 Usage tips:

1. Particle size determined by laser diffraction or microscopy.

2. Radiochemical purity checked by centrifugation or filtration.

3. Ho-166 produced by neutron activation of stable Ho-165 in nuclear reactor.

4. Drug requires thorough mixing before administration to avoid sedimentation.

5. Post-therapeutic imaging is possible due to Ho-166 gamma emission (80.6 keV).

⚠️ Note: Ho-166 microspheres combine therapeutic effect (beta radiation) and diagnostic potential (gamma radiation), allowing precise verification of drug distribution in liver after procedure. This makes quality control especially important for dose planning.

input.csv

BatchNumber,RadiochemicalPurityPercent,FreeHolmiumPercent,ParticleSizeMeanUm,ParticleSizeD90Um,SpecificActivityMBq_per_mg,pH,EndotoxinsEU_per_mL,SterilityTest,ActivityGBq,RadionuclidicPurityPercent,Ho166mImpurityPercent
HO166-MS-2026-001,99.0,0.5,25.0,35.0,3000.0,7.0,10.0,0,6.0,99.99,0.0005
HO166-MS-2026-002,97.0,2.5,28.0,40.0,2500.0,6.5,20.0,0,5.5,99.95,0.0008
HO166-MS-2026-003,95.0,4.0,15.0,55.0,1500.0,7.5,50.0,1,4.0,99.80,0.0020

URS & FS — user requirements and functional specification

URS — User Requirements Specification

The utility shall accept input.csv with these mandatory columns: BatchNumber, RadiochemicalPurityPercent, FreeHolmiumPercent, ParticleSizeMeanUm, ParticleSizeD90Um, SpecificActivityMBq_per_mg, pH, EndotoxinsEU_per_mL, SterilityTest, ActivityGBq, RadionuclidicPurityPercent, Ho166mImpurityPercent.
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

Run Ho166MicrosphereQualityChecker.exe in demonstration mode or with input.csv output.json arguments.
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,RadiochemicalPurityPercent,FreeHolmiumPercent,ParticleSizeMeanUm,ParticleSizeD90Um,SpecificActivityMBq_per_mg,pH,EndotoxinsEU_per_mL,SterilityTest,ActivityGBq,RadionuclidicPurityPercent,Ho166mImpurityPercent
HO166-MS-2026-001,99.0,0.5,25.0,35.0,3000.0,7.0,10.0,0,6.0,99.99,0.0005
HO166-MS-2026-002,97.0,2.5,28.0,40.0,2500.0,6.5,20.0,0,5.5,99.95,0.0008
HO166-MS-2026-003,95.0,4.0,15.0,55.0,1500.0,7.5,50.0,1,4.0,99.80,0.0020

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": "Ho166MicrosphereQualityChecker",
  "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.

Ho166MicrosphereQualityChecker