AAS_Glass_Leachables_Test

URS & FS — User Requirements and Functional Specification

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

• • Glass can leach metal ions and alkali, especially during sterilization and storage.
• • USP <660> and Ph. Eur. 3.2.1 classify glass into Types I, II, III, NP based on hydrolytic resistance.
• • Type I (borosilicate) is the most inert, used for parenteral products.
• • Atomic Absorption Spectrometry (AAS) on Lumex MGA-1000 allows precise determination of trace Pb, Cd, As in water extract.
• • Titration determines the amount of released alkali (hydrolysis of silicate network).
• • Alkalinity ≤10.0 mL 0.01M HCl — criterion for Type I Glass compliance (Powdered Glass Test).
• • Lead, Cadmium, Arsenic are toxic elements; their leaching must be minimal.
• • Glass degradation ("delamination") can lead to visible particles in the product.
• • Control is necessary for each batch of primary packaging.
• • Assessment of glass hydrolytic resistance.
• • Control of toxic metal impurities in the extract.
• • Compliance with USP <660> and Ph. Eur. 3.2.1 requirements.
• • Lead: ≤5.0 ppm
• • Cadmium: ≤0.5 ppm
• • Arsenic: ≤0.5 ppm
• • Alkalinity (Hydrolytic Resistance): ≤10.0 mL 0.01M HCl

URS — User Requirements Specification

input.csv contract

BatchNumber,Pb_ppm,Cd_ppm,As_ppm,Alkalinity_mL_HCl
GLASS-VIAL-2026-001,0.8,0.05,0.05,1.2
GLASS-AMP-2026-002,1.2,0.10,0.10,2.5
GLASS-FAIL-2026-003,6.0,0.80,0.70,15.0

FS — Functional Specification

Example output.json

{
  "utilityId": "aas-glass-leachables-test",
  "utilityName": "AAS_Glass_Leachables_Test",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "GLASS-VIAL-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Pb_ppm",
      "value": "0.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Cd_ppm",
      "value": "0.05",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "As_ppm",
      "value": "0.05",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Alkalinity_mL_HCl",
      "value": "1.2",
      "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.