This course provides hands-on training on the science of sterilization (microbiology and thermal science) with a validated steam autoclave and thermal validation equipment. Bring your challenges to the course and brainstorm possible solutions with the class and instructor while running actual loads.
Moist heat sterilization processes are considered to be "special processes" since the output of the process, product sterility, cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat sterilization processes be properly designed, validated and controlled. This course will provide a foundational understanding of sterilization science that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. The course is based on the latest revision of PDA's most popular sterilization reference, PDA Technical Report No. 1, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control. Since its issuance, it has been widely utilized by industry and regulatory sterilization professionals in the development and assessment of sterilization programs across the globe.
The laboratory hands-on part of the class will include actual cycle execution with data review. During this section of the class the attendees will be encouraged to discuss challenges being faced or expected to be faced. The class will then participate in brainstorming over possible solutions. Based on the load items discussed, actual load runs will be executed, so that attendees can observe actual performance. If the attendee can bring an example of the load item, it will be integrated into the lab execution.
Who Should Attend
Manufacturing Operations, Formulation, Engineering, QA/QC, Product and Process Development, Regulatory Affairs, Research and Development, Sterility Assurance, Technical Operations and Validation Professionals.