Depyrogenation
Depyrogenation is a process that aims the reduction of pyrogens with the use of hot air in temperature ranging from 160°C up to 400°C. The temperature depends on the duration of the process. Gravity or mechanical heat convection can be used for this process.
Depyrogenation is mainly used in the sterilization of vials for aseptic filling. The process is also used to sterilize packaged materials, since heat conduction does not require the contact of the product with steam or water.
Batch and dynamic are the two main techniques for depyrogenation. Batch production is usually done in static ovens where the product is placed in metal crates and exposed to high temperatures. Dynamic involves the use of a depyrogenation tunnel, where goods are transported over a continuous band through different heating zones of the tunnel.
Tunnel validation test should incluede empty and loaded thermal mapping, speed of the conveyor as well as HVAC.