Depyrogenation Tunnel Process Validation/Qualification

Depyrogenation Tunnel Process Validation/Qualification

Depyrogenation tunnels are critical equipment in parenteral pharmaceutical manufacturing, providing continuous inline sterilization and depyrogenation of glass vials and ampoules. Validating these systems requires specialised expertise in high-temperature thermometric surveying and endotoxin challenge methodology.

IETQAN validates depyrogenation tunnels in accordance with EU GMP Annex 1 and applicable USP depyrogenation guidance, demonstrating the required 3-log reduction of endotoxin across all zones and conveyor speeds for the defined production range. Our validation approach is fully aligned with the expectations of international regulatory inspectors, and our reports have been accepted in multiple markets.