Tc99mMDPQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Tc99mMDPQualityChecker for Tc-99m MDP.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Tc-99m MDP:
• • Radiochemical purity (≥95%)
• • Free pertechnetate (≤5%)
• • Colloidal technetium (≤5%)
• • Aluminum content (≤10 ppm) — CRITICAL!
• • pH, endotoxins, sterility
• ⚠️ CRITICAL: Aluminum breakthrough from generator (>10 ppm) leads to colloid formation.
• BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,AluminumContentPPM,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — Low RCP reduces image contrast. Free technetium creates background in soft tissues, stomach, and thyroid.
• • Free pertechnetate ≤5% — Artifacts in neck and chest area.
• • Reduced/Hydrolyzed Tc ≤5% — Colloid accumulating in liver.
• • pH 4.0–7.5, Endotoxins ≤175 EU/vial, Sterility — standard requirements.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,AluminumContentPPM,ProductType
TC99M-MDP-2026-030,740.0,98.0,1.5,0.5,6.5,10.0,0,2.0,BoneScintigraphy
TC99M-MDP-AL-FAIL,700.0,96.0,2.0,2.0,6.8,15.0,0,15.0,BoneScintigraphy
TC99M-MDP-RCP-FAIL,720.0,88.0,8.0,4.0,6.2,12.0,0,1.5,BoneScintigraphy

FS — Functional Specification

Example output.json

{
  "utilityId": "tc99m-mdp-quality-checker",
  "api": "Tc-99m MDP",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TC99M-MDP-2026-030",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "740.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreePertechnetatePercent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ReducedHydrolyzedTcPercent",
      "value": "0.5",
      "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": "10.0",
      "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.