Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control

This training course is based on 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. This training course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control.

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. Important moist heat sterilization topics also covered by this training course include:

• Application of key terms including D-value, z-value, physical (F0), biological lethality (FBIO), steam quality and equilibration time
• Considerations in the use of steam and water requirements for moist heat processes
• Fundamentals in the selection and use of biological indicators and chemical indicators
• Selection of a sterilization process type based on product attributes
• Design considerations for key and critical parameters
• Determination of cold spots
• Practical application of semi-log survivor curve equation in sterilization calculations
• Use the overkill approach and alternates to the overkill approach (product specific approach)
• Use of master site and master solution approach
• Use of bracketing approaches to optimize process qualification activities
• Sterilizer suitability and equivalency
• Parametric release of moist heat sterilized products
• Impact assessment for product, process and sterilization equipment modifications

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. Use 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 loads types
5. List the critical elements of process performance qualification