Tablet_Coating_Uniformity_NIR

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface, user requirements and functional behaviour of Tablet_Coating_Uniformity_NIR. 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

• • Mean coating thickness: within ±10% of target
• • Relative Standard Deviation (RSD): ≤5.0%
• • Coating Quality Index (CQI): ≥0.95
• • Traditional methods (weight gain, micrometry) are laborious and do not provide information on local non-uniformity.
• • Near-Infrared Spectroscopy (NIR) allows rapid, non-contact assessment of polymer film thickness.
• • The method is based on spectral differences between the tablet core and the polymer coating.
• • InfraLUM FT-12 instruments allow integration of probes directly into the coating drum (on-line/at-line).
• • Coating uniformity directly affects product stability and API release profile.
• • Calibration model (PLS/PCR) must be built for the specific core/polymer combination.
• • Surface roughness and tablet orientation can affect the spectrum; averaged sampling is required.
• • RSD ≤5% is a generally accepted criterion for a good coating process for most standard tablets.
• • Monitoring humidity and temperature in the drum is important as they affect NIR spectra.
• • Rapid assessment of coating homogeneity.
• • Calculation of integral Coating Quality Index (CQI).
• • Support for Lumex NIR spectrometer data.
• • Mean Thickness: Target ±10%

URS — User Requirements Specification

input.csv contract

BatchNumber,MeanThickness_um,StdDev_um,RSD_percent,CQI
COAT-NIR-2026-001,50.0,1.5,3.0,0.98
COAT-NIR-2026-002,48.0,2.0,4.2,0.96
COAT-FAIL-2026-003,42.0,5.5,13.0,0.85

FS — Functional Specification

Example output.json

{
  "utilityId": "tablet-coating-uniformity-nir",
  "utilityName": "Tablet_Coating_Uniformity_NIR",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "COAT-NIR-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "MeanThickness_um",
      "value": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "StdDev_um",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RSD_percent",
      "value": "3.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "CQI",
      "value": "0.98",
      "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.