Validation of Dry Heat Sterilization and Depyrogenation

Abstract

This chapter details the steps of a program that may be employed to properly specify equipment and validate a dry heat process. The validation of a dry heat sterilization and depyrogenation process involves approaches and procedures that parallel those utilized for steam sterilization. The efficiency of any heat treatment is determined by the design and source of the heating medium. Hot air is substantially less efficient as a thermal transfer medium compared with steam. The choice of the thermocouple type and insulation surrounding the wires is dependent on the operating temperature and required temperature accuracy. For dry heat sterilization or depyrogenation processes, both type T (copper and constantan) and type J (iron and constantan) thermocouples can be used. An appropriate sterilization or depyrogenation cycle must be developed before validation testing commences. Complete records and documentation of the cycle development must be referenced or included within the validation documentation.