Erbium169QualityChecker

1. Scope

This document defines requirements and functional behaviour for Erbium169QualityChecker used to control: Erbium-169. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• Erbium169QualityChecker.exe — demo mode or help output.
• Erbium169QualityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Erbium-169 Quality Checker — Radiocolloid for Synovectomy (Ph. Eur., USP)
• ℹ️ The utility checks particle size, RCP, free ions, sterility, endotoxins.
• ⚠️ CRITICAL! Particle size 100-1000 nm. Free ions ≤2%. Endotoxins ≤2.5 EU/mL!
• BatchNumber,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_mg,Particle_Size_Mean_nm,Particle_Size_Max_nm,Aggregation_Percent,Free_Erbium_Ion_Percent,Target_Material_Residue_ppm,pH_Value,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
• • Particle Size: Critical. Particles must be large enough (100–1000 nm) to remain in the joint space and not migrate to lymph nodes or bloodstream. Too small particles (<100 nm) are dangerous due to systemic spread.
• • Radiochemical Purity: Presence of free $^{169}\text{Er}^{3+}$ ions is unacceptable as they rapidly leave the joint and accumulate in liver and bones. RCP must be ≥98%.
• • Sterility and Endotoxins: Drug is injected directly into the joint. Endotoxin requirements are extremely strict (≤2.5 EU/mL) to avoid post-injection inflammation.
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.0%
• • Radiochemical Purity: ≥ 98.0%
• • Free Erbium Ions: ≤ 2.0%
• • Max Particle Size: ≤ 5000 nm
• • Aggregation: ≤ 5.0%
• • pH: 5.0–8.0
• • Endotoxins: ≤ 2.5 EU/mL (Critical for joints)
• • Sterility: No growth
• ⚠️ Note: Utility focuses on specific radiocolloid parameters: particle size and absence of free ions. Deviation in particle size is a critical defect leading to treatment inefficacy or systemic toxicity.

4. URS — user requirements

5. input.csv contract

BatchNumber,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_mg,Particle_Size_Mean_nm,Particle_Size_Max_nm,Aggregation_Percent,Free_Erbium_Ion_Percent,Target_Material_Residue_ppm,pH_Value,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
ER169-COL-2026-001,99.9,99.2,500.0,400.0,1500.0,1.0,0.5,2.0,6.5,0,1.0,0,0,0,0,0

6. FS — functional specification

7. output.json example

{
  "utilityId": "erbium169-quality-checker",
  "api": "Erbium-169",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ER169-COL-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radionuclidic_Purity_Percent",
      "value": "99.9",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiochemical_Purity_Percent",
      "value": "99.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Specific_Activity_MBq_mg",
      "value": "500.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Particle_Size_Mean_nm",
      "value": "400.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Particle_Size_Max_nm",
      "value": "1500.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Aggregation_Percent",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Free_Erbium_Ion_Percent",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

8. OQ/PQ test scenarios

9. QA/QC and change control

• Do not rename columns without validator update.
• Store 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 checked against the approved specification and local SOPs.