BacterialEndotoxinAndSterilityCombined_QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of BacterialEndotoxinAndSterilityCombined_QualityChecker for Bacterial Endotoxin & Sterility Combined Quality Checker.

Domain limits and critical parameters

• Bacterial Endotoxin & Sterility Combined Quality Checker — Combined Safety Control for Vaccines
• ℹ️ Utility performs comprehensive verification of two critical safety parameters for parenteral vaccines according to Ph. Eur. and USP:
• • Bacterial Endotoxins (BET/LAL): Calculation of individual limit using K/M formula (where K=5.0 EU/kg for most drugs).
• ⚠️ CRITICAL:
• • Exceeding endotoxin limit causes pyrogenic reactions (fever, shock).
• BacterialEndotoxinAndSterilityCombinedQualityChecker.exe → demo mode (console output)
• BacterialEndotoxinAndSterilityCombinedQualityChecker.exe input.csv output.json → evaluate your data
• BatchNumber,ProductName,Endotoxin_EU_per_ml,MaxDose_ml_per_kg,K_Factor,TSB_Growth,FTG_Growth,NegativeControl_TSB,NegativeControl_FTG,PositiveControl_TSB,PositiveControl_FTG,IncubationDays,BET_Recovery_Percent
• • Endotoxin Limit (K/M): Depends on route of administration. For intrathecal drugs K=0.2 EU/kg, for other parenterals K=5.0 EU/kg.
• • Interference: Some vaccines may inhibit LAL reaction. Recovery test (Spike) must be performed.
• • Automatic calculation of endotoxin limit based on dose
• • Compliance with Ph. Eur. 2.6.1, 2.6.14 and USP <71>, <85>
• Critical parameters:
• • Endotoxins: ≤ K/M EU/mL
• 2. Dilution: If product inhibits LAL, use maximum possible dilution not exceeding sensitivity limit.
• 3. Asepsis: Sterility sampling must be performed in Class A conditions.

URS — User Requirements Specification

input.csv contract

BatchNumber,ProductName,Endotoxin_EU_per_ml,MaxDose_ml_per_kg,K_Factor,TSB_Growth,FTG_Growth,NegativeControl_TSB,NegativeControl_FTG,PositiveControl_TSB,PositiveControl_FTG,IncubationDays,BET_Recovery_Percent
SAFE-2026-VAC-001,Inactivated Polio Vaccine,1.5,0.1,5.0,0,0,0,0,1,1,14,95.0
SAFE-2026-FAIL-002,DTPa Vaccine,60.0,0.5,5.0,0,0,0,0,1,1,14,90.0
SAFE-2026-INVALID-003,HepB Vaccine,2.0,0.5,5.0,0,0,1,0,1,1,14,92.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "bacterialendotoxinandsterilitycombined-qualitychecker",
  "utilityFolder": "BacterialEndotoxinAndSterilityCombined_QualityChecker",
  "package": "huvac",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "SAFE-2026-VAC-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ProductName",
      "value": "Inactivated Polio Vaccine",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "Endotoxin_EU_per_ml",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "MaxDose_ml_per_kg",
      "value": "0.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "K_Factor",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "TSB_Growth",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "FTG_Growth",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "NegativeControl_TSB",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "NegativeControl_FTG",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "PositiveControl_TSB",
      "value": "1",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "PositiveControl_FTG",
      "value": "1",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "IncubationDays",
      "value": "14",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-012"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "BacterialEndotoxinAndSterilityCombined_QualityChecker.documentation.html"
  }
}

Traceability matrix

IQ/OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating validator, documentation 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 limits shall be verified against the approved specification, registration dossier and local SOPs.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.