Manganese52QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Manganese52QualityChecker for Manganese-52.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Manganese-52:
• • Radionuclidic purity (≥99.0%)
• • Manganese-54 impurity (≤0.1%)
• • Manganese-56 impurity (≤1.0%)
• • Radiochemical purity (≥95%)
• • Free manganese (≤5%)
• • pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Mn-54 impurity >0.1% → long-term radiation burden (T½=312 days)!
• Free manganese >5% → accumulation in liver and pancreas!
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Manganese54ImpurityPercent,Manganese56ImpurityPercent,RadiochemicalPurityPercent,FreeManganesePercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Manganese-54 impurity ≤0.1% — Mn-54 (T½=312 days) is a long-lived gamma emitter. Even trace amounts create significant radiation burden to the patient over months and years.
• • Manganese-56 impurity ≤1.0% — Mn-56 (T½=2.6 h) has high-energy gamma lines, increasing dose to staff and patient in the first hours after administration.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Manganese54ImpurityPercent,Manganese56ImpurityPercent,RadiochemicalPurityPercent,FreeManganesePercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
Mn52-TRACER-2026-001,500.0,99.5,0.05,0.1,98.0,1.5,6.5,40.0,0,2,PET_Tracer
Mn52-TRACER-2026-002,480.0,98.5,0.2,0.5,94.0,6.0,6.0,180.0,0,8,PET_Tracer
Mn52-RES-2026-001,600.0,99.8,0.02,0.05,99.0,0.5,7.0,20.0,0,1,Research

FS — Functional Specification

Example output.json

{
  "utilityId": "manganese52-quality-checker",
  "api": "Manganese-52",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "Mn52-TRACER-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "500.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Manganese54ImpurityPercent",
      "value": "0.05",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Manganese56ImpurityPercent",
      "value": "0.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeManganesePercent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "6.5",
      "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.