Rhenium188QualityChecker

1. Scope

This document defines requirements and functional behaviour for Rhenium188QualityChecker used to control: Rhenium-188. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• Rhenium188QualityChecker.exe — demo mode or help output.
• Rhenium188QualityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Rhenium-188 Quality Checker — Radiopharmaceutical (Generator-based) (Ph. Eur., USP)
• ℹ️ The utility checks W-188 breakthrough, RCP, free perrhenate, sterility.
• ⚠️ CRITICAL! W-188 breakthrough ≤0.005%. Free perrhenate ≤5%. Sterility mandatory!
• BatchNumber,Formulation_Type,Radionuclidic_Purity_Percent,Tungsten_188_Breakthrough_ppm,Radiochemical_Purity_Percent,Free_Perrhenate_Percent,Hydrolyzed_Reduced_Re_Percent,Specific_Activity_MBq_mg,pH_Value,Ethanol_Content_Percent,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
• • Tungsten-188 Breakthrough: Critical parameter. W-188 has a half-life of 69 days (vs 17 hours for Re-188). Even trace amounts of W-188 lead to significant additional patient dose in the long term. Limit is extremely strict (≤0.005% or <50 ppm).
• • Radiochemical Purity: As with Re-186, it is important to control free perrhenate (thyroid) and hydrolyzed rhenium (liver).
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.9%
• • W-188 Breakthrough: ≤ 0.005% (Critical!)
• • 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 controlling parent nuclide (W-188) breakthrough, which is a specific issue for generator-produced radiopharmaceuticals. Deviation in W-188 content is grounds for batch rejection due to long-term radiotoxicity.

4. URS — user requirements

5. input.csv contract

BatchNumber,Formulation_Type,Radionuclidic_Purity_Percent,Tungsten_188_Breakthrough_ppm,Radiochemical_Purity_Percent,Free_Perrhenate_Percent,Hydrolyzed_Reduced_Re_Percent,Specific_Activity_MBq_mg,pH_Value,Ethanol_Content_Percent,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
RE188-LIP-2026-001,Lipiodol,99.99,0.001,98.0,1.0,0.5,1000.0,6.0,5.0,0,10.0,0,0,0,0,0

6. FS — functional specification

7. output.json example

{
  "utilityId": "rhenium188-quality-checker",
  "api": "Rhenium-188",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "RE188-LIP-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Formulation_Type",
      "value": "Lipiodol",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radionuclidic_Purity_Percent",
      "value": "99.99",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Tungsten_188_Breakthrough_ppm",
      "value": "0.001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiochemical_Purity_Percent",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Free_Perrhenate_Percent",
      "value": "1.0",
      "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": "Specific_Activity_MBq_mg",
      "value": "1000.0",
      "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.