Palladium103QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Palladium103QualityChecker for Palladium-103.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Palladium-103:
• • Radionuclidic purity (≥99.9%)
• • Palladium-109 impurity (≤0.1%)
• • Chemical purity (≥99.0%)
• • Radiochemical purity (≥98.0%)
• • pH, endotoxins, sterility
• ⚠️ CRITICAL: Pd-109 impurity >0.1% → beta emission unpredictably alters dose!
• Sterility failure → high risk of infection during permanent implantation!
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Palladium109ImpurityPercent,Silver103ImpurityPercent,RadiochemicalPurityPercent,ChemicalPurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Chemical purity ≥99.0% — Presence of target material (e.g., Rhodium-103, if produced via Rh-103(p,n)) or other metals can disrupt the coating process on the graphite rod inside the seed, affecting activity uniformity.
• • Sterility and endotoxins — Critical as seeds are implanted directly into patient tissues.
• • Radiochemical purity — Determines the form of palladium (usually chloride or metal coating), important for the seed manufacturing process.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Palladium109ImpurityPercent,Silver103ImpurityPercent,RadiochemicalPurityPercent,ChemicalPurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
Pd103-SEED-2026-001,400.0,99.95,0.02,0.01,99.5,99.9,3.0,10.0,0,1,Brachytherapy_Seeds
Pd103-SEED-2026-002,380.0,99.80,0.15,0.05,98.0,99.5,3.5,180.0,0,8,Brachytherapy_Seeds
Pd103-RES-2026-001,500.0,99.99,0.005,0.001,99.9,99.99,2.0,5.0,0,0.5,Research_Solution

FS — Functional Specification

Example output.json

{
  "utilityId": "palladium103-quality-checker",
  "api": "Palladium-103",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "Pd103-SEED-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "400.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.95",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Palladium109ImpurityPercent",
      "value": "0.02",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Silver103ImpurityPercent",
      "value": "0.01",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ChemicalPurityPercent",
      "value": "99.9",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "3.0",
      "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.