pHConductivityWaterQualityChecker

pH & Conductivity Water

LabEx laboratory QC CSV→JSON URS & FS microbiology utilities / cleanroom
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pH & Conductivity Water Quality Checker — Control of Pharmaceutical Water Quality

ℹ️  Utility checks critical parameters of Purified Water (PW) and Water for Injection (WFI):
   • Conductivity: ≤1.3 µS/cm (at 25°C, USP <645>)
   • pH: 5.0–7.0 (USP <645> Stage 2 / Ph. Eur.)
   • Temperature compensation of conductivity limits

⚠️  CRITICAL: Exceeding conductivity indicates ionic contamination!
   Incorrect pH may indicate CO2 absorption or ammonia contamination.

Usage:
 pHConductivityWaterQualityChecker.exe                            → demo mode (console output)
 pHConductivityWaterQualityChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,MeasuredPH,ConductivityUScm,TemperatureC,WaterType

Example:
 WFI-LOOP-2026-001,5.8,0.9,25.0,WFI

— WHY IS THIS NEEDED?
Water is the most widely used substance in pharmaceutical manufacturing.
• USP <645> and Ph. Eur. 2.2.38 regulate methods for conductivity and pH control.
• Conductivity is the primary indicator of water purity (absence of ions).
• pH is controlled to confirm absence of acidic or alkaline contaminants.
• Automation of temperature limit checks eliminates manual table comparison errors.

⚠️  CRITICAL:
• Measurements must be performed online (in-line) or immediately after sampling (at-line) to avoid CO2 absorption from air.
• CO2 absorption lowers pure water pH to ~5.5, which is normal but can be mistaken for contamination.
• Conductivity cell must be calibrated before use.
• For WFI, requirements are stricter than for regular purified water (especially for endotoxins, but here only phys-chem).

Key features:
• Conductivity check with temperature consideration.
• pH range control.
• Support for PW and WFI water types.

Critical parameters:
• Conductivity: <= Limit (Temp Dependent)
• pH: 5.0 - 7.0

💡 Usage tips:
1. Use flow-through cells to minimize air contact.
2. Regularly clean electrodes from biofilms.
3. Check sample temperature as conductivity is highly T-dependent.
4. If conductivity is normal (Stage 1 Pass), pH test may not be required by USP, but is often performed for data completeness.
5. Store conductivity and pH meter calibration data for auditing.

⚠️ Note: Pure water has very low buffer capacity, so its pH is extremely unstable in air. Conductivity is a more reliable and reproducible parameter for purity control.

input.csv

BatchNumber,pH,Conductivity_uScm,Temperature_C,WaterType
WFI-LOOP-2026-001,5.8,0.9,25.0,WFI
PW-TANK-2026-001,6.2,1.1,22.0,PW
WATER-FAIL-2026-001,7.5,2.5,25.0,WFI

URS & FS — pH & Conductivity Water

This document describes the user requirements and functional specification for pHConductivityWaterQualityChecker. The utility is intended for QC laboratory use as a rule-based check of data prepared from an instrument, LIMS, ELN, MES or an approved input.csv.

URS — User Requirements Specification

IDRequirementCriticalityAcceptance criterion
URS-001The utility shall accept input.csv with approved columns: BatchNumber, pH, Conductivity_uScm, Temperature_C, WaterType.HighThe CSV file is processed without manual header editing.
URS-002The utility shall perform deterministic evaluation for “pH & Conductivity Water” without machine learning.HighThe same input data produce the same JSON result.
URS-003The utility shall validate mandatory fields, numeric formats, flags, ranges and domain plausibility.HighSchema and conversion errors are explicitly reported.
URS-004The utility shall generate output.json with PASS / WARNING / FAIL statuses, source values, warnings and failures.HighThe JSON result is suitable for review, deviation investigation and integration.
URS-005The documentation shall support IQ/OQ/PQ or CSV/CSA verification.MediumURS/FS, CSV/JSON contract and test scenarios are supplied with the utility.

input.csv contract

#FieldSamplePurpose
1BatchNumberWFI-LOOP-2026-001Input parameter for deterministic QC evaluation.
2pH5.8Input parameter for deterministic QC evaluation.
3Conductivity_uScm0.9Input parameter for deterministic QC evaluation.
4Temperature_C25.0Input parameter for deterministic QC evaluation.
5WaterTypeWFIInput parameter for deterministic QC evaluation.

FS — Functional Specification

IDFunctionImplementation
FS-001CSV importRead input.csv; validate header, column count and encoding.
FS-002Schema validationCheck required fields and permitted input values.
FS-003Rule engineApply domain rules, limits and system suitability/specification checks described in the source utility description.
FS-004Status aggregationProduce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance.
FS-005JSON exportWrite machine-readable output.json for LIMS/ELN/MES and QA/QC review.

OQ/PQ scenarios

  • OQ-001: a valid sample row shall be processed without schema error.
  • OQ-002: a missing mandatory column shall produce a schema error.
  • OQ-003: a non-numeric value in a numeric field shall produce a conversion error.
  • OQ-004: a critical parameter outside the limit shall produce FAIL or a critical finding.
  • PQ-001: user real batches shall be checked with retention of input.csv, output.json, utility version and checksum.

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