Fluorat_Mycotoxins_Ochratoxin

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface, user requirements and functional behaviour of Fluorat_Mycotoxins_Ochratoxin. The utility is intended for automated verification of laboratory, pharmacopoeial, analytical or manufacturing QC parameters using input.csv and producing a structured output.json result.

Domain limits and critical parameters

• • Concentration: ≤5.0 ng/mL (example limit for extract)
• • Signal-to-Noise Ratio (SNR): ≥3.0
• • Inhibition (for immunoassay): 20–80% (linear range)
• ⚠️ CRITICAL: Exceeding limit → raw material toxicity (nephrotoxic effect)!
• • It is highly toxic (nephrotoxin, IARC Group 2B carcinogen).
• • Fluorometric methods (including those using immunoaffinity purification or ELISA) provide high sensitivity and selectivity.
• • Lumex Fluorat instruments allow detection of trace toxin amounts due to low noise levels and excitation source stability.
• • Control is mandatory for ensuring the safety of herbal medicines and food products.
• • OTA content limits are strictly regulated (e.g., in EU for raw materials often ≤5-10 µg/kg).
• • High matrix fluorescence can interfere with analysis (matrix interference), requiring thorough extract cleanup.
• • Immunofluorescent methods require control of linear range (inhibition 20-80%).
• • Reagent light sensitivity requires working in dim conditions.
• • High-sensitivity mycotoxin screening.
• • Signal quality control (SNR).
• • Validity check of immunochemical reaction (Inhibition).
• • Ochratoxin A Content: <= Limit (e.g., 5.0 ng/mL)

URS — User Requirements Specification

input.csv contract

BatchNumber,Concentration_ng_mL,SampleRFU,BlankRFU,Inhibition_%
HERB-OTA-2026-001,2.5,1500.0,50.0,45.0
HERB-OTA-2026-002,4.8,2800.0,60.0,60.0
HERB-FAIL-2026-003,12.5,8000.0,55.0,95.0

FS — Functional Specification

Example output.json

{
  "utilityId": "fluorat-mycotoxins-ochratoxin",
  "utilityName": "Fluorat_Mycotoxins_Ochratoxin",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "HERB-OTA-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Concentration_ng_mL",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SampleRFU",
      "value": "1500.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "BlankRFU",
      "value": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Inhibition_%",
      "value": "45.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "generatedFor": "QA/QC review and LIMS integration"
}

Traceability matrix

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator, documentation and test set.
• Retain input.csv, output.json, executable version, documentation and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits must be verified against the approved specification, local SOPs and registration dossier.