AluminumFluoride18FQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of AluminumFluoride18FQualityChecker for [18F]AlF.

Domain limits and critical parameters

• ℹ️ The utility checks RCP, free fluoride, residual aluminum, sterility, endotoxins.
• ⚠️ CRITICAL! RCP ≥95%. Aluminum ≤10 ppm. Free fluoride ≤5%!
• • Radiochemical Purity: Must be ≥95%. Main impurity is free [18F]fluoride, which accumulates in bones and degrades image quality.
• • Residual Aluminum: Used as salts (AlCl3). Excess aluminum is toxic. Limit is strict (≤10 ppm).
• • Free Fluoride: Must be minimal (<5%) as it competes for bone binding.
• • Sterility and Endotoxins: Drug is administered intravenously. Requirements are strict.
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.0%
• • Radiochemical Purity: ≥ 95.0%
• • Specific Activity: ≥ 10 GBq/umol
• • Free Fluoride: ≤ 5.0%
• • Aluminum: ≤ 10 ppm
• • Precursor: ≤ 50 ppm
• • Ethanol: ≤ 10%

URS — User Requirements Specification

input.csv contract

BatchNumber,Radiopharmaceutical,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_GBq_umol,Free_Fluoride_Percent,Aluminum_Residue_ppm,Precursor_Residue_ppm,Ethanol_Content_Percent,Acetonitrile_Residue_ppm,pH_Value,Osmolality_mOsm_kg,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
F18-ALF-2026-001,[18F]AlF-NOTA-PEG3-RGD,99.9,98.0,30.0,1.5,5.0,10.0,5.0,50.0,6.5,290,0,5.0,0,0,0,0,0

FS — Functional Specification

Example output.json

{
  "utilityId": "aluminum-fluoride18-f-quality-checker",
  "api": "[18F]AlF",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "F18-ALF-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiopharmaceutical",
      "value": "[18F]AlF-NOTA-PEG3-RGD",
      "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": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Specific_Activity_GBq_umol",
      "value": "30.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Free_Fluoride_Percent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Aluminum_Residue_ppm",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Precursor_Residue_ppm",
      "value": "10.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator and test set.
• Retain 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 verified against the approved specification and local SOPs.