November 29, 2023

112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer

47 minutes

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting.

Jeanne and I discuss:

-Steam Sterilization - Moist and Dry Heat

-Biological/Chemical Indicators, Placement and Resistance

-Cycle Development and Validation

-Overkill Cycles vs Product Specific Cycles

-Parametric Release of Steam Sterilized 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.

...more