Depyrogenation Tunnels
Depyrogenation Tunnels Validation Services
Vashishta Engineering Services provides specialized validation solutions for depyrogenation tunnels, critical systems designed to eliminate pyrogens and sterilize glassware, vials, and containers in pharmaceutical manufacturing processes.
How Depyrogenation Tunnels Work
Depyrogenation tunnels utilize continuous high-temperature processes to destroy endotoxins and achieve sterility. Containers move through the tunnel on a conveyor belt system, passing through precisely controlled temperature zones:
Pre-heating Zone: Gradual temperature increase to minimize thermal shock
High-Temperature Sterilization Zone: Sustained exposure to temperatures typically ranging from 250°C to 350°C
Cooling Zone: Controlled temperature reduction for safe container handling
Our Validation Services Include:
Temperature Mapping: Comprehensive profiling of all temperature zones
Belt Speed Validation: Verification of conveyor speed consistency and dwell times
HEPA Filter Integrity Testing: Certification of air filtration systems
Airflow Pattern Analysis: Validation of unidirectional airflow patterns
Performance Qualification: Testing with worst-case load scenarios
Environmental Monitoring: Particulate and non-viable particle testing
Key Validation Parameters:
Temperature uniformity and stability (±5°C or better)
Heat distribution consistency across all zones
Endotoxin reduction verification (3-log reduction minimum)
Sterility assurance level (SAL) of 10⁻⁶
Compliance with USP <1211> and ISO 17665 standards