PDA 468 Validation of Moist Heat Sterilization Processes

Based on PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control, this training course will provide a foundational understanding of sterilization science that can be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. Hands-on activities will include actual sterilization cycle operations and execution with data review. The class will then participate in brainstorming over possible solutions to challenges. If the attendee can bring an example of the load item, it will be integrated into the autoclave execution.

Participants will also receive a free copy of PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control.

1. Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
2. Develop a decision tree to select the most appropriate sterilization process based on the attributes of the load type
3. Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program
4. Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods load types
5. List the critical elements of process performance qualification