Essentials of Sterilization for Med Device Professionals

Global Medical Device Podcast · 26 Jan 2023 · 37m · Episode 303

What this episode covers

Laura Maher, a Medical Device Guru at Greenlight Guru, explains the technical differences between sterilization modalities like gamma radiation and ethylene oxide (EO), including material compatibility issues with silicone and batteries. She details the validation processes, such as bio-burden testing and dose audits, and highlights emerging FDA-recognized modalities like chlorine dioxide that offer safer in-house options. Maher also discusses critical sterility pitfalls, including packaging failures, water system biofilm management, and the risks of bacterial endotoxins from high initial bioburden.

Most relevant to

early-stage companies

Topics

Mentioned

Companies: Greenlight Guru, Nelson Labs
Also: Chlorine Dioxide, Ethylene Oxide, Gamma Radiation

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The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.

Essentials of Sterilization for Med Device Professionals

What this episode covers

Most relevant to

Topics

Mentioned

Related episodes from other shows

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

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

131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer

S6E51 Eric Richins | What It's Like Being A Packaging Engineer

70 - Charlie Webb from Van Der Stahl Scientific