PowderFlowQualityChecker

Powder Flow

LabEx laboratory QC CSV→JSON URS & FS solid dosage forms
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Powder Flow Quality Checker — Control of Powder Flowability

ℹ️  Utility checks critical flowability parameters according to USP <616>:
   • Carr's Index: ≤15% (Good flowability)
   • Hausner Ratio: ≤1.18 (Good flowability)
   • Angle of Repose: ≤30° (Excellent/Good)

⚠️  CRITICAL: Poor flowability leads to tablet and capsule weight variations!
   This can cause batch rejection during compression or encapsulation stages.

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

Input format:
BatchNumber,BulkDensity_g_ml,TappedDensity_g_ml,AngleOfRepose_deg,CarrsIndex,HausnerRatio

Example:
 POW-FLOW-2026-001,0.45,0.55,28.0,18.18,1.22

— WHY IS THIS NEEDED?
Powder flowability is a key technological parameter for solid dosage forms.
• Affects filling of tablet press dies and capsule dosators.
• Determined by ratio of bulk and tapped density, and angle of repose.
• USP <616> classifies flowability from "Excellent" to "Very Very Poor".
• Automation of index calculations eliminates manual computation errors.

⚠️  CRITICAL:
• Carr's Index >25% indicates very poor flowability, requiring granulation or glidants.
• Angle of Repose >40° indicates strong particle cohesion.
• Measurement method must be standardized (drop height, funnel diameter).
• Humidity and static electricity strongly affect measurement results.

Key features:
• Calculation and verification of Carr's Index and Hausner Ratio.
• Assessment of Angle of Repose.
• Flowability classification per USP scale.

Critical parameters:
• Carr's Index: <= 15% (Target for Good Flow)
• Hausner Ratio: <= 1.18 (Target for Good Flow)
• Angle of Repose: <= 30°

💡 Usage tips:
1. Perform measurements under controlled humidity conditions.
2. Use standard tapping methods (e.g., 100-500 taps for tapped density).
3. For sticky powders, consider using glidants (colloidal silicon dioxide).
4. Compare results of different raw material batches to identify trends.
5. Optimize granulation process if flowability is poor.

⚠️ Note: Flowability is a complex property depending on particle size, shape, roughness, and humidity. One parameter (e.g., angle of repose) may not give full picture, so combination of methods is recommended.

input.csv

BatchNumber,BulkDensity,TappedDensity,AngleOfRepose,CarrsIndex,HausnerRatio
POW-FLOW-2026-001,0.45,0.55,28.0,18.18,1.22
POW-FLOW-2026-002,0.50,0.52,24.0,3.85,1.04
POW-FAIL-2026-003,0.30,0.50,45.0,40.0,1.66

URS & FS — Powder Flow

This document describes the user requirements and functional specification for PowderFlowQualityChecker. 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, BulkDensity, TappedDensity, AngleOfRepose, CarrsIndex, HausnerRatio.HighThe CSV file is processed without manual header editing.
URS-002The utility shall perform deterministic evaluation for “Powder Flow” 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
1BatchNumberPOW-FLOW-2026-001Input parameter for deterministic QC evaluation.
2BulkDensity0.45Input parameter for deterministic QC evaluation.
3TappedDensity0.55Input parameter for deterministic QC evaluation.
4AngleOfRepose28.0Input parameter for deterministic QC evaluation.
5CarrsIndex18.18Input parameter for deterministic QC evaluation.
6HausnerRatio1.22Input 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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