Join hosts Jason Pope and Lise Vanderkelen in this informative webinar that will delve into the essential aspects of thermal disinfection validation studies and steam sterilization validations. These processes are critical steps in the reprocessing cycle of reusable medical devices, each with its own unique requirements and challenges. This session aims to provide attendees with a comprehensive understanding of these validation procedures and their significance in ensuring device safety and efficacy.
The webinar will begin by exploring the importance of validating thermal disinfection procedures. Attendees will learn why it is crucial to validate these procedures to demonstrate the effectiveness of disinfection, ensuring that all microbial contaminants are adequately eliminated. This segment will cover the scientific principles behind thermal disinfection, the key parameters to monitor, and the common pitfalls to avoid during validation.
Next, the session will shift focus to steam sterilization validation, outlining the three critical steps needed to achieve successful sterilization: sterility assurance level (SAL), dry time validation, and thermocoupling. Attendees will gain insights into each of these steps, understanding how to measure and achieve the required SAL, the importance of validating dry times to ensure complete drying of devices, and the role of thermocoupling in monitoring and controlling the sterilization process.
The webinar will also address the different regulatory requirements for thermal disinfection and steam sterilization validations in the European Union (EU) and the United States (US). Participants will learn about the specific standards and guidelines that must be met in each region, ensuring their processes are compliant with both EU and US regulations.
By the end of this webinar, attendees will have a deeper understanding of the critical aspects of thermal disinfection and steam sterilization validation studies. This knowledge is essential for professionals involved in the reprocessing of reusable medical devices, including quality assurance personnel, regulatory affairs specialists, and validation engineers. Equipped with these insights, participants will be better prepared to implement effective and compliant validation procedures, ensuring the safety and reliability of their reprocessed devices.