Cobalt57QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Cobalt57QualityChecker for Cobalt-57.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of cobalt-57:
• • Radionuclidic purity (≥99.9%)
• • Cobalt-56 impurity (≤0.05%) — long-lived impurity (T½=77 days)
• • Cobalt-58 impurity (≤0.05%) — (T½=71 days)
• • Chemical purity, pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Co-56 and Co-58 impurities increase patient radiation dose and create background noise!
• BatchNumber,RadionuclidicPurityPercent,Co56ImpurityPercent,Co58ImpurityPercent,ChemicalPurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radionuclidic purity ≥99.9% — ensures signal clarity and reduces dose
• • Co-56 impurity ≤0.05% — Co-56 has high gamma yield and long half-life, which is undesirable
• • Co-58 impurity ≤0.05% — creates additional background
• • Endotoxins ≤175 EU/vial — for parenteral administration
• • Sterility — MANDATORY for diagnostic products

URS — User Requirements Specification

input.csv contract

BatchNumber,RadionuclidicPurityPercent,Co56ImpurityPercent,Co58ImpurityPercent,ChemicalPurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
CO57-DIAG-2026-001,99.95,0.02,0.01,98.5,6.0,50.0,0,2,Diagnostic
CO57-CAL-2026-002,99.92,0.04,0.03,99.0,5.5,10.0,0,1,CalibrationSource

FS — Functional Specification

Example output.json

{
  "utilityId": "cobalt57-quality-checker",
  "api": "Cobalt-57",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "CO57-DIAG-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.95",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Co56ImpurityPercent",
      "value": "0.02",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Co58ImpurityPercent",
      "value": "0.01",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ChemicalPurityPercent",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "6.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SterilityTest",
      "value": "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.