Rhenium186QualityChecker

1. Scope

This document defines requirements and functional behaviour for Rhenium186QualityChecker used to control: Rhenium-186. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• Rhenium186QualityChecker.exe — demo mode or help output.
• Rhenium186QualityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Rhenium-186 Quality Checker — Radiopharmaceutical (Therapy) (Ph. Eur., USP)
• ℹ️ The utility checks RCP, free perrhenate, hydrolyzed rhenium, particle size (colloids), sterility.
• ⚠️ CRITICAL! Free perrhenate ≤5%. Hydrolyzed Re ≤5%. Sterility mandatory!
• BatchNumber,Formulation_Type,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_mg,Free_Perrhenate_Percent,Hydrolyzed_Reduced_Re_Percent,Particle_Size_Mean_nm,pH_Value,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
• • Radiochemical Purity: Critical to distinguish three forms:
• 2. Free perrhenate ($^{186}\text{ReO}_4^-$): Accumulates in thyroid, stomach, and salivary glands. Limit ≤5%.
• 3. Hydrolyzed reduced rhenium ($\text{ReO}_2$): Colloidal particles accumulating in liver and spleen. Limit ≤5%.
• • Sterility and Endotoxins: Drug is administered intra-articularly or intravenously. Requirements are strict.
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.0%
• • Radiochemical Purity: ≥ 95.0%
• • Free Perrhenate: ≤ 5.0%
• • Hydrolyzed Rhenium: ≤ 5.0%
• • pH: 4.0–8.0
• • Endotoxins: ≤ 17.5 EU/mL
• • Sterility: No growth
• ⚠️ Note: Utility focuses on specific rhenium impurities (perrhenate and hydroxide/oxide) which have completely different biodistribution than the target drug, leading to incorrect dosimetry and toxicity.

4. URS — user requirements

5. input.csv contract

BatchNumber,Formulation_Type,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_MBq_mg,Free_Perrhenate_Percent,Hydrolyzed_Reduced_Re_Percent,Particle_Size_Mean_nm,pH_Value,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
RE186-COL-2026-001,Colloid,99.9,98.5,500.0,0.8,0.5,400.0,6.5,0,5.0,0,0,0,0,0
RE186-HEDP-2026-001,Complex,99.9,97.0,200.0,2.0,1.0,0.0,7.0,0,10.0,0,0,0,0,0

6. FS — functional specification

7. output.json example

{
  "utilityId": "rhenium186-quality-checker",
  "api": "Rhenium-186",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "RE186-COL-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Formulation_Type",
      "value": "Colloid",
      "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": "98.5",
      "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": "Free_Perrhenate_Percent",
      "value": "0.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Hydrolyzed_Reduced_Re_Percent",
      "value": "0.5",
      "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"
    }
  ],
  "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.