AdjuvantAdsorptionEfficiency_QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of AdjuvantAdsorptionEfficiency_QualityChecker for Adjuvant Adsorption Efficiency Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility assesses the degree of antigen binding to aluminum adjuvant (aluminum hydroxide or phosphate) according to Ph. Eur. 5.2.2 and internal vaccine manufacturer standards:
• • Adsorption Efficiency: Calculated as % of antigen bound to adjuvant. Norm: ≥ 90-95%.
• • Free Antigen: Amount of unadsorbed protein in supernatant. Must be minimal.
• • pH of Medium: Critical parameter affecting adjuvant surface charge and protein stability.
• ⚠️ CRITICAL: Low adsorption efficiency (<90%) means a significant part of the antigen will be rapidly cleared from the body without depot formation!
• ⚠️ CRITICAL:
• • pH: Adsorption is maximal when pH is close to the protein's isoelectric point (IEP) and opposite to the adjuvant's charge.
• • Compliance with Ph. Eur. 5.2.2 and GMP requirements
• Critical parameters:
• • Adsorption Efficiency: ≥ 90%
• • Free Antigen: ≤ 10% of total amount
• 5. Validation: Phase separation method must be validated for completeness of adjuvant precipitation/filtration.

URS — User Requirements Specification

input.csv contract

BatchNumber,ProductName,AdjuvantType,TotalAntigen_ug_per_ml,FreeAntigen_ug_per_ml,AluminumContent_mg_per_ml,pH,SeparationMethod
ADJ-2026-HEPB-001,Hepatitis B Vaccine,AluminiumHydroxide,20.0,0.5,0.5,6.2,Centrifugation
ADJ-2026-DTP-002,DTPa Vaccine,AluminiumPhosphate,100.0,2.0,0.33,5.8,Filtration
ADJ-2026-FAIL-003,Pneumococcal Conj.,AluminiumHydroxide,50.0,15.0,0.5,6.0,Centrifugation

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "adjuvantadsorptionefficiency-qualitychecker",
  "utilityFolder": "AdjuvantAdsorptionEfficiency_QualityChecker",
  "package": "huvac",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ADJ-2026-HEPB-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ProductName",
      "value": "Hepatitis B Vaccine",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "AdjuvantType",
      "value": "AluminiumHydroxide",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "TotalAntigen_ug_per_ml",
      "value": "20.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "FreeAntigen_ug_per_ml",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "AluminumContent_mg_per_ml",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "pH",
      "value": "6.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "SeparationMethod",
      "value": "Centrifugation",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "AdjuvantAdsorptionEfficiency_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.