This section addresses the principles and validation of dry heat sterilization processes used in GMP environments. It covers heat distribution and penetration studies, load configuration, cycle development, critical temperature control, and requalification strategy to ensure reliable microbial inactivation and reproducible lethality.
Dry heat sterilization uses controlled exposure to heated air to inactivate viable microorganisms on heat-stable materials. Unlike moist heat sterilization, it does not depend on saturated steam contacting the load. Heat must be transferred from the surrounding air through the…
Dry heat sterilization qualification demonstrates that an oven or continuous tunnel is installed correctly, operates as intended, and repeatedly delivers the required microbial lethality to the most difficult-to-heat locations within approved load configurations. Qualification must evaluate more than chamber or…