Astatine211QualityChecker

1. Scope

This document defines requirements and functional behaviour for Astatine211QualityChecker used to control: Astatine-211. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• Astatine211QualityChecker.exe — demo mode or help output.
• Astatine211QualityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Astatine-211 Quality Checker — Astatine-211 for targeted alpha therapy
• ℹ️ Utility checks critical parameters of astatine-211:
• • Radionuclidic purity (≥99.9%)
• • Astatine-210 impurity (≤0.001%) — CRITICAL!
• • Radiochemical purity (≥95%)
• • Free astatine (≤5%) — volatility and thyroid uptake risk
• • pH (5.0–8.0), endotoxins, sterility
• ⚠️ CRITICAL: Astatine-210 impurity >0.001% → formation of polonium-210 (deadly poison)!
• BatchNumber,ActivityMBq,RadionuclidicPurityPercent,At210ImpurityPercent,RadiochemicalPurityPercent,FreeAstatinePercent,pH,EndotoxinsEU,SterilityTest,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• • MABG — therapy for neuroblastoma and pheochromocytoma
• • ANTIBODY — targeted alpha therapy with monoclonal antibodies
• Astatine-211 is one of the most promising alpha-emitters for micrometastasis therapy:
• • Alpha radiation (5.87 MeV) — high linear energy transfer (LET), effective single-cell killing
• ⚠️ CRITICAL:
• • Radionuclidic purity ≥99.9% — ensures absence of other radioactive contaminants
• • Astatine-210 impurity ≤0.001% — CRITICAL! At-210 decays to Polonium-210 (T½=138 days). Polonium-210 is a potent toxin that accumulates in the body and creates lifelong radiation burden. Even trace amounts are unacceptable!
• • Free astatine ≤5% — FREE astatine is volatile (like iodine) and actively taken up by the thyroid gland, causing hypothyroidism and local irradiation. Also risks air contamination in the lab.
• • Radiochemical purity ≥95% — ensures alpha particle delivery specifically to the target (tumor).
• • pH 5.0–8.0 — optimal range for stability of most At-C and At-N conjugates.

4. URS — user requirements

5. input.csv contract

BatchNumber,ActivityMBq,RadionuclidicPurityPercent,At210ImpurityPercent,RadiochemicalPurityPercent,FreeAstatinePercent,pH,EndotoxinsEU,SterilityTest,ProductType
AT211-DEMO-001,500.0,99.95,0.0005,97.5,2.0,6.5,50.0,0,MABG
AT211-FAIL-002,480.0,99.5,0.005,90.0,8.0,4.0,100.0,0,PSMA

6. FS — functional specification

7. output.json example

{
  "utilityId": "astatine211-quality-checker",
  "api": "Astatine-211",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "AT211-DEMO-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ActivityMBq",
      "value": "500.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.95",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "At210ImpurityPercent",
      "value": "0.0005",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "97.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeAstatinePercent",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "6.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "50.0",
      "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.