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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-04-10
- Length: 42m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-10-131-novel-sterilization-methods-for-drugs-devices-combination-products-ema-decis
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/131---Novel-Sterilization-Methods-for-Drugs--Devices--Combination-Products--EMA-Decision-TreeAssessing-Aseptic-Filling-and-Sterility-Priniciples-with-Jeanne-Moldenhauer-e2i6uk9

## Summary

Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting, explains the regulatory framework for sterilizing drug-device combination products, focusing on the EMA's decision tree which prioritizes terminal sterilization over aseptic filling. She details novel methods such as liquid phase sterilization, ionization, and high-pressure techniques, noting that pharmaceutical companies are often reluctant to adopt them due to perceived regulatory risk despite their availability. Moldenhauer argues that traditional methods (steam, dry heat, radiation, gas, aseptic) are sufficient for nearly all products, but novel approaches like liquid phase sterilization are critical for complex items like 3D-printed artificial organs.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-10-131-novel-sterilization-methods-for-drugs-devices-combination-products-ema-decis#t=0) Introduction: Subi Sedate and Jeanne Moldenhauer
- [2:45](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-10-131-novel-sterilization-methods-for-drugs-devices-combination-products-ema-decis#t=165) EMA Decision Tree and Terminal Sterilization Priority
- [7:15](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-10-131-novel-sterilization-methods-for-drugs-devices-combination-products-ema-decis#t=435) Biological Indicators and Product Compatibility
- [12:36](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-10-131-novel-sterilization-methods-for-drugs-devices-combination-products-ema-decis#t=756) Liquid Phase Sterilization and Self-Sterilizing Solutions
- [20:40](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-10-131-novel-sterilization-methods-for-drugs-devices-combination-products-ema-decis#t=1240) Physics-Based, High Pressure, and Flash Sterilization
- [33:59](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-10-131-novel-sterilization-methods-for-drugs-devices-combination-products-ema-decis#t=2039) Novel Gases and Radiation Technologies
- [37:53](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-10-131-novel-sterilization-methods-for-drugs-devices-combination-products-ema-decis#t=2273) Regulatory Reluctance and Validation of Novel Methods

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

early-stage companies

## Mentioned

- Excellent Pharma Consulting (company)
- EMA (other)
- FDA (other)
- USP 1229 (other)
- MAPP 504.01 (other)
- PDA (other)
- Sterigenics (company)

## Related episodes from other shows

- [Essentials of Sterilization for Med Device Professionals](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-26-essentials-of-sterilization-for-med-device-professionals) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [How to Choose the Right FDA Regulatory Pathway for your Device](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [Demystifying the De Novo Process](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process) (Global Medical Device Podcast)

## Citing this page

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