PyrogenTestRabbitMATQualityChecker

Pyrogen Test (Rabbit & MAT) Quality Checker — Control of Pyrogenicity

ℹ️  Utility checks pyrogen test results according to USP <151> and Ph. Eur. 2.6.30:
   • Rabbit Pyrogen Test:
     - Sum temperature increase in 3 rabbits < 1.4 °C
     - Individual increase < 0.6 °C
   • Monocyte Activation Test (MAT):
     - Endotoxin equivalent concentration ≤ specified limit

⚠️  CRITICAL: Positive result indicates presence of pyrogens!
   Product cannot be released until cause is investigated and retesting performed.

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

Input format:
BatchNumber,TestType,SumTemperatureIncrease,MaxIndividualIncrease,NumberOfRabbits,CalculatedEndotoxinEquivalent,MATLimit

Example (Rabbit):
 PYRO-RAB-2026-001,Rabbit,0.8,0.4,3,0,0
Example (MAT):
 PYRO-MAT-2026-001,MAT,0,0,0,0.25,0.5

— WHY IS THIS NEEDED?
Pyrogens (fever-causing substances) may be present in parenteral products even in absence of bacteria.
• Rabbit Pyrogen Test (USP <151>) is classic biological method detecting wide range of pyrogens.
• MAT (Monocyte Activation Test, Ph. Eur. 2.6.30) is modern alternative using human monocytes to detect both endotoxins and non-endotoxin pyrogens (NEPs).
• MAT is gradually replacing rabbit test in Europe due to ethics (3R) and sensitivity.
• Automation eliminates interpretation errors of complex temperature curves or MAT calibration data.

⚠️  CRITICAL:
• For rabbit test: animals must be healthy and kept in controlled conditions.
• For MAT: important to exclude sample interference with clotting system or cells.
• Positive result requires investigation of contamination source (raw material, water, process).
• MAT requires use of standard endotoxin for calibration curve construction.

Key features:
• Support for both main pharmacopoeial methods.
• Verification of sum and individual limits for rabbits.
• Assessment of endotoxin equivalent for MAT.

Critical parameters:
• Rabbit Sum Temp: < 1.4 °C
• Rabbit Individual Temp: < 0.6 °C
• MAT Endotoxin Equivalent: <= Limit

💡 Usage tips:
1. Use validated commercial reagent kits for MAT.
2. For rabbit test, strictly adhere to measurement time (usually 3 hours).
3. Account for ambient temperature when preparing rabbits.
4. Perform System Suitability Test (SST) before each MAT run.
5. Document any deviations in animal behavior or MAT reagent color.

⚠️ Note: MAT is more sensitive to non-endotoxin pyrogens (e.g., Gram-positive bacterial cell wall components, viruses) than traditional LAL test, making it preferred for complex biologics.