ViscosityRheologyQualityChecker

Viscosity & Rheology

LabEx laboratory QC CSV→JSON URS & FS utilities / cleanroom
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Viscosity & Rheology Quality Checker — Control of Viscosity and Rheology

ℹ️  Utility assesses rheological parameters of pharmaceutical liquids, gels, and ointments according to USP <911>:
     • Dynamic Viscosity (cP or mPa·s) — resistance to flow
     • Shear Rate (1/s) — measurement condition (critical for non-Newtonian fluids)
     • Yield Stress (Pa) — stress required to initiate flow (for ointments/suspensions)
     • Flow Behavior: Newtonian, Pseudoplastic (shear-thinning), Dilatant, Plastic
     • Strict temperature control (±0.5°C)

⚠️  CRITICAL: Viscosity depends exponentially on temperature! Temperature deviation >0.5°C invalidates the result.
     Change in flow behavior (e.g., from pseudoplastic to Newtonian) indicates irreversible structure breakdown.

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

Input format:
BatchNumber,ProductName,Viscosity_cP,ShearRate_1_per_s,YieldStress_Pa,Temperature_C,FlowBehavior,Density_g_cm3

Example:
  VISC-2026-GEL-001,Carbomer Gel 1%,25000.0,10.0,15.0,25.0,Pseudoplastic,1.01

— WHY IS THIS NEEDED?
Viscosity affects processability (filling, pumping), suspension stability (sedimentation), and consumer properties (spreadability of cream, ease of application).
For eye drops and nasal sprays, viscosity is critical for mucosal contact time.

⚠️  CRITICAL:
• Measurement Condition: For non-Newtonian fluids (gels, creams), viscosity depends on shear rate. Always specify shear rate or spindle/speed.
• Temperature: Measurements must be performed in a thermostated cell.
• Yield Stress: Presence of yield stress prevents ointment from dripping off skin or particles from settling in suspension during storage.
• Thixotropy: If viscosity depends on shear time, this must be accounted for in the method.

Key features:
• Viscosity check considering shear rate
• Yield stress control for structured systems
• Flow behavior identification
• Strict temperature control
• Generation of reports for R&D and QC departments, and LIMS LabWare
• Compliance with USP <911> and Ph. Eur. 2.2.10

Critical parameters:
• Viscosity: within specification (product-dependent)
• Temperature: 25.0 ± 0.5°C (or other specified)
• Yield Stress: ≥ specified minimum (if applicable)
• Flow Behavior: strict compliance (e.g., Pseudoplastic)

💡 Usage tips:
1. Method Selection: Use coaxial cylinders for low-viscosity liquids, cone-plate or parallel plates for high-viscosity ointments.
2. Degassing: Air bubbles in sample distort results. Degas sample before measurement.
3. Recovery Time: For thixotropic gels, allow sample to rest after loading into cell before starting measurement.
4. Calibration: Regularly check instrument with standard fluids of known viscosity (silicone oils).
5. Cleaning: Thoroughly clean geometry between measurements; residues of previous sample cause huge errors.

⚠️ Note: Rheology is not just a single viscosity number, but the material's behavior under deformation. This utility helps control key points of this behavior to ensure quality.

input.csv

BatchNumber,ProductName,Viscosity_cP,ShearRate_1_per_s,YieldStress_Pa,Temperature_C,FlowBehavior,Density_g_cm3
VISC-2026-GEL-001,Carbomer Gel 1%,25000.0,10.0,15.0,25.0,Pseudoplastic,1.01
VISC-2026-SYR-002,Cough Syrup,150.0,50.0,0.0,25.0,Newtonian,1.25
VISC-2026-OINT-003,Petrolatum Ointment,80000.0,1.0,120.0,25.0,Plastic,0.90

URS & FS — Viscosity & Rheology

This document describes the user requirements and functional specification for ViscosityRheologyQualityChecker. 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, ProductName, Viscosity_cP, ShearRate_1_per_s, YieldStress_Pa, Temperature_C, FlowBehavior, Density_g_cm3.HighThe CSV file is processed without manual header editing.
URS-002The utility shall perform deterministic evaluation for “Viscosity & Rheology” 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
1BatchNumberVISC-2026-GEL-001Input parameter for deterministic QC evaluation.
2ProductNameCarbomer Gel 1%Input parameter for deterministic QC evaluation.
3Viscosity_cP25000.0Input parameter for deterministic QC evaluation.
4ShearRate_1_per_s10.0Input parameter for deterministic QC evaluation.
5YieldStress_Pa15.0Input parameter for deterministic QC evaluation.
6Temperature_C25.0Input parameter for deterministic QC evaluation.
7FlowBehaviorPseudoplasticInput parameter for deterministic QC evaluation.
8Density_g_cm31.01Input 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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