AAS_Dialysis_Fluid_Monitor

URS & FS — User Requirements and Functional Specification

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

• • Calcium (Ca): within ±5% of label claim
• • Magnesium (Mg): within ±5% of label claim
• • Sodium (Na): within ±5% of label claim
• • Potassium (K): within ±5% of label claim
• • Aluminum (Al): ≤10.0 ppb (µg/L)
• • Accuracy of main electrolytes (Na, K, Ca, Mg) is vital to prevent arrhythmias and seizures.
• • Aluminum can enter dialysate from water or chemical reagents.
• • Since the dialyzer membrane is permeable to aluminum, its excess in dialysate leads to direct accumulation in the patient's body.
• • Atomic Absorption Spectrometry (AAS) on Lumex MGA-1000 allows precise control of both macro-elements (flame mode) and trace aluminum (graphite furnace).
• • Aluminum ≤10 ppb — strict safety limit (complies with Ph. Eur. and USP requirements for dialysis water/fluids).
• • Electrolytes must strictly match concentrate formulation (usually ±5% tolerance).
• • Regular monitoring prevents mass patient intoxications.
• • Use of pure water (reverse osmosis) for preparing dialysate is mandatory.
• • Comprehensive control of electrolyte composition.
• • Strict supervision of toxic aluminum content.
• • Compliance with clinical hemodialysis safety standards.

URS — User Requirements Specification

input.csv contract

BatchNumber,Ca_mg_L,Mg_mg_L,Na_mg_L,K_mg_L,Al_ppb
DIAL-CONC-2026-001,60.0,15.0,8000.0,100.0,2.5
DIAL-CONC-2026-002,61.0,15.5,8100.0,102.0,4.0
DIAL-FAIL-AL-003,60.0,15.0,8000.0,100.0,15.0

FS — Functional Specification

Example output.json

{
  "utilityId": "aas-dialysis-fluid-monitor",
  "utilityName": "AAS_Dialysis_Fluid_Monitor",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "DIAL-CONC-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Ca_mg_L",
      "value": "60.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Mg_mg_L",
      "value": "15.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Na_mg_L",
      "value": "8000.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "K_mg_L",
      "value": "100.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Al_ppb",
      "value": "2.5",
      "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.