114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne talks through the different methods of irradiation like gamma, beta, microwave, x-ray, and ebeam, their respective pros and cons, as well as their environmental impacts. Jeanne also delves into the practical considerations associated with this sterilization method. This includes important factors like product density, cycle development, dosimeters, sterilization and the bioburden. The episode ends with a look at the regulatory approval process, addressing the timeline for validating an irradiation sterilization cycle. 00:22 Understanding Irradiation Sterilization 00:34 Differences between Autoclaving and Irradiation 04:22 The Impact of Product Density on Irradiation 05:09 The Role of Dose in Irradiation Sterilization 06:21 E-beam Sterilization 08:52 Impact of Gamma Sterilization on Different Materials 22:07 The Role of Bioburden in Irradiation Sterilization 30:19 Dosimetric Release 37:31 Gamma Irradiation for Combination Products 41:59 The Process of Validating an Irradiation Sterilization Cycle 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.