Strontium82BreakthroughChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Strontium82BreakthroughChecker for Strontium-82 Breakthrough.

Domain limits and critical parameters

• Strontium-82 Breakthrough Checker — Strontium-82 Breakthrough Analyzer (Rb-82 Generators)
• ℹ️ Utility checks strontium breakthrough compliance with USP <823>:
• • Sr-82 Limit: ≤20 Bq per 1 MBq Rb-82
• • Sr-85 Limit: ≤500 Bq per 1 MBq Rb-82
• ⚠️ CRITICAL: Exceeding Sr-82 limit requires immediate removal of generator from service!
• Strontium82BreakthroughChecker.exe → demo mode (console output)
• Strontium82BreakthroughChecker.exe input.csv output.json → evaluate your data
• ⚠️ CRITICAL:
• • Breakthrough test must be performed regularly (usually daily or before first use of the day).
• Critical parameters:
• • Sr-82/Rb-82 ratio: ≤20 Bq/MBq
• • Sr-85/Rb-82 ratio: ≤500 Bq/MBq
• 3. Records of breakthrough test must be kept in the Nuclear Medicine department quality log.
• ⚠️ Note: Unlike other quality tests, this test determines the VERY POSSIBILITY of using the generator. A positive result (exceeding limit) is an absolute contraindication for administering the drug to a patient.

URS — User Requirements Specification

input.csv contract

BatchNumber,Rb82ActivityMBq,Sr82ActivityBq,Sr85ActivityBq,ElutionVolumeMl,TimeSinceCalibrationHours,GeneratorID
RUBID-CHECK-2026-001,1500.0,15.0,100.0,50.0,0.5,GEN-SR82-XYZ-099
RUBID-FAIL-2026-002,1000.0,50000.0,200000.0,50.0,1.0,GEN-SR82-OLD-001
RUBID-CHECK-2026-003,1200.0,10.0,50.0,40.0,0.2,GEN-SR82-NEW-055

FS — Functional Specification

Example output.json

{
  "utilityId": "strontium82-breakthrough-checker",
  "api": "Strontium-82 Breakthrough",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "RUBID-CHECK-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Rb82ActivityMBq",
      "value": "1500.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Sr82ActivityBq",
      "value": "15.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Sr85ActivityBq",
      "value": "100.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ElutionVolumeMl",
      "value": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TimeSinceCalibrationHours",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "GeneratorID",
      "value": "GEN-SR82-XYZ-099",
      "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.