Hardware Podcasts

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

Let's Combinate · 27 Dec 2023 · 39m

What this episode covers

Jeanne Moldenhauer, a sterilization expert, explains the mechanics of gas sterilization, emphasizing that penetration requires gas-permeable packaging like Tyvek rather than hermetic seals. She details the process involving preconditioning, gas exposure, and critical aeration to remove toxic residuals, particularly for Ethylene Oxide (ETO). The discussion covers various gases including ETO, VHP, chlorine dioxide, and ozone, highlighting safety risks, OSHA regulations, and validation strategies like half-cycle qualification to ensure sterility assurance levels.

Most relevant to

early-stage companies

Topics

Mentioned

Materials
Tyvek
Also
Ethylene Oxide, VHP, Chlorine Dioxide, Ozone, USP 1229

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