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Thermal Disinfection & Steam Sterilization Validation for Reusable Devices

Published Date: April 8, 2021

As part of the three-part webinar series on cleaning, disinfection and sterilization validations of reusable devices, this 50-minute webinar will address the final installment. This time, Jason Pope and Lise Vanderkelen will address some of the key aspects of what is required for thermal disinfection validation studies and steam sterilization validations. These are two different, but important, steps in the processing cycle of reusable devices.

This session should give you a deeper understanding of:

  • Why a validation of the thermal disinfection procedure is crucial to demonstrate the effectiveness of the disinfection.
  • The 3 different steps that you need to include to obtain a successful steam sterilization (sterility assurance level, dry time validation & thermocoupling)
  • The different requirements for EU and US registrations
Lise Vanderkelen

Lise Vanderkelen

Pharmaceuticals and Microbiology Expert

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016,...

Jason Pope

Senior Scientist

Jason Pope is a certified quality auditor and specializes in providing consultations for clients about sterilization of reusable medical devices, endoscopes, and pharmaceuticals and general sterilization validation process development. He has over 22 years of experience working in research and development, validation, and routine control of various sterilization processing modalities including, but not limited to, steam, ethylene oxide (EO), dry heat, and H2O2 sterilization. Jason also specializes in developing sterilization testing protocols for new packaging products prior to regulatory clearance submissions.

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