Depyrogenation Tunnels Validation Services

Continuous High-Speed Container Sterilization

Pharma Integrity Validations & Services offers specialized validation services for continuous depyrogenation tunnels. These critical systems destroy pyrogens and achieve container sterility in high-speed automated aseptic filling lines.

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How Depyrogenation Tunnels Operate

Depyrogenation tunnels move containers along a continuous conveyor system across three distinct thermal zones:

• Drying & Pre-heating Zone: Gradual thermal ramp-up to prevent glass thermal shock.
• Sterilization Zone: Exposure to laminar hot air (250°C to 350°C) for complete pyrogen destruction.
• Cooling Zone: Laminar sterile air flow reducing container temperature prior to filling.

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Our Validation Scope & Key Parameters

• Conveyor Belt Speed Mapping: Dwell-time calculation across variable speed settings.
• Multi-Zone Thermal Profiling: Real-time wireless logging across heating and cooling boundaries.
• Airflow Velocity & Differential Pressure: Balancing pressure differentials to prevent cross-zone contamination.
• Endotoxin Challenge Verification: Confirming $\ge 3\text{-log}$ endotoxin reduction using spiked glass vials.
• HEPA Filter Integrity: In-situ PAO testing across all heating and cooling zone filter banks.