Dry Heat Ovens

Components and products. Dry heat sterilization is often used for heat-stable oils, ointments and powders. Most often, depyrogenation of parenteral containers is performed utilizing a dry heat oven. The depyrogenation process is also utilized on certain heat-stabile components, glass containers, metal equipment, etc. to render the item and final parenteral product free of pyrogens. The equipment utilized to provide the dry heat medium must be validated to ensure that the system is able to provide sterile and/or depyrogenated components, on a reproducible basis. The validation of a dry heat sterilization and depyrogenation process involves approaches and procedures which parallel those utilized for steam sterilization. The efficiency of any heat treatment is determined by the design and source of the heat. Hot air is substantially less efficient in a thermal transfer medium as compared to steam. The validation effort must include heat distribution, heat penetration, bioburden and pyroburden determination, filter integrity and microbial/endotoxin challenges.