116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer

In this episode, I was joined by Jeanne Moldenhauer, a sterilization expert to discuss all things gas sterilization. Jeanne and I explore how efficiency is determined by the seal of the container and the type of material being sterilized. Jeanne discusses its application in medical devices, the challenge of permeability, and its comparative cost-effectiveness. Jeanne delves into how the sterilization process works, safety considerations, validation, and the use of gas sterilization in combination products. Lastly, Jeanne discuss sterilization process development and the challenges that come with gas sterilization. 00:23 Deep Dive into Gas Sterilization 00:46 Applications and Limitations of Gas Sterilization 01:51 Understanding Material Permeability in Gas Sterilization 02:29 Gas Sterilization in Medical Devices 06:15 Different Types of Gases Used in Sterilization 07:41 Safety and Environmental Risks of Gas Sterilization 14:14 Understanding the Gas Sterilization Process 18:25 Safety Measures in Handling Gas Sterilization 25:39 Validation and Bioburden Considerations in Gas Sterilization 35:28 Gas Sterilization in Combination Products Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.