ParticleCountInjectionUSP788QualityChecker

Particle Count Injection USP <788> Quality Checker — Control of Subvisible Particles in Injections

ℹ️  Utility checks compliance of subvisible particle content with USP <788> requirements:
   • For small volumes (<100 mL): ≤6000 particles/container (≥10 µm), ≤600 particles/container (≥25 µm)
   • For large volumes (≥100 mL): ≤25 particles/mL (≥10 µm), ≤3 particles/mL (≥25 µm)

⚠️  CRITICAL: Exceeding particle limits can cause embolism or inflammatory reaction!
   Requires use of Light Obscuration method or microscopy.

Usage:
 ParticleCountInjectionUSP788QualityChecker.exe                            → demo mode (console output)
 ParticleCountInjectionUSP788QualityChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,SampleVolumeMl,ParticlesGe10um,ParticlesGe25um,LimitType

Example:
 INJ-SVP-2026-001,10.0,500,50,PerContainer

— WHY IS THIS NEEDED?
Control of mechanical inclusions is critical for safety of parenteral products.
• USP <788> regulates permissible levels of particle contamination.
• Light Obscuration method is the primary quantitative method.
• Distinction between SVP (Small Volume Parenterals) and LVP (Large Volume Parenterals) is important for correct limit application.
• Automation eliminates manual calculation and table comparison errors.

⚠️  CRITICAL:
• Sample must be degassed to exclude air bubbles, which are counted as particles.
• Diluent must be particle-free (filtered).
• Instrument must be calibrated using standard spheres (NIST traceable).
• If results exceed limits, confirmatory test by microscopic method is performed.

Key features:
• Automatic limit selection based on volume type (SVP/LVP).
• Verification of both particle sizes (10 and 25 µm).
• Generation of PASS/FAIL status for QC reports.

Critical parameters:
• Particles ≥10 µm: Within Limit
• Particles ≥25 µm: Within Limit

💡 Usage tips:
1. Thoroughly clean instrument sensor between samples to avoid cross-contamination.
2. Perform test in Class A laminar flow hood to exclude background contamination.
3. Use correct instrument sensitivity threshold settings.
4. For viscous products, dilution with filtered solvent may be required.
5. Record background count of solvent before starting series.

⚠️ Note: USP <788> applies only to solutions intended for intravascular administration. For suspensions or emulsions, other assessment methods apply.