BacterialCountBioburdenChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of BacterialCountBioburdenChecker for Bacterial Count Bioburden Checker.

Domain limits and critical parameters

• ℹ️ Utility assesses the level of microbial bioburden in non-sterile pharmaceutical products according to Ph. Eur. 2.6.12 and USP <61>:
• ⚠️ CRITICAL:
• • Exceeding established limits (e.g., 100 CFU/g for TAMC) indicates unsatisfactory raw material quality or hygiene violations in production.
• • Limits depend on route of administration and product type (oral, topical, rectal, etc.).
• • Neutralization: If product contains preservatives, neutralizers must be used in the culture medium.
• • Verification of compliance with TAMC and TYMC limits
• • Compliance with GMP and Pharmacopoeia requirements
• Critical parameters:
• • TAMC: ≤ 100 CFU/g (for topical products)
• • TYMC: ≤ 10 CFU/g (for topical products)
• • Recovery Efficiency: ≥ 50%
• 1. Sampling: Must be representative and performed aseptically.
• 3. Colony Counting: Use only plates with colony counts between 10 and 300 (or up to 250 per USP) for accuracy.

URS — User Requirements Specification

input.csv contract

BatchNumber,ProductName,TAMC_CFU_per_unit,TYMC_CFU_per_unit,SampleWeight_g,DilutionFactor,IncubationDays_TAMC,IncubationDays_TYMC,RecoveryEfficiency_Percent
BB-2026-CREAM-001,Hydrocortisone Cream,50.0,10.0,1.0,10.0,3,5,85.0
BB-2026-SYRUP-002,Cough Syrup,20.0,5.0,10.0,1.0,4,6,90.0
BB-2026-FAIL-003,Herbal Powder,150.0,25.0,1.0,100.0,3,5,40.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "bacterialcountbioburdenchecker",
  "utilityFolder": "BacterialCountBioburdenChecker",
  "package": "Vet",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "BB-2026-CREAM-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ProductName",
      "value": "Hydrocortisone Cream",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "TAMC_CFU_per_unit",
      "value": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "TYMC_CFU_per_unit",
      "value": "10.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "SampleWeight_g",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "DilutionFactor",
      "value": "10.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "IncubationDays_TAMC",
      "value": "3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "IncubationDays_TYMC",
      "value": "5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "RecoveryEfficiency_Percent",
      "value": "85.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "BacterialCountBioburdenChecker.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.