This live eLearning training course focuses on the microbiology and principles for qualification of dry heat sterilization and depyrogenation processes as well as the general approach to sterilization and depyrogenation science in batch and continuous sterilizers (ovens and tunnels). Current industry practices and approaches to validating dry heat depyrogenation processes will be covered in addition to various aspects of dry heat as a sterilization process. Points to consider in equipment design, equipment verification, process development and performance qualification for new systems and the development and validation of processes for existing systems will also be discussed.
Participants will understand equipment options and the factors for consideration in qualification, validation and ongoing maintenance. During this training course, participants will learn about the use and limitations of endotoxin indicators and biological indicators and the calculations used to determine inactivation of both types of challenges. Participants will have an opportunity to discuss actual problems encountered and consider causes and possible solutions.