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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-12-13
- Length: 43m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/114---Irradiation-Sterilization--Gamma--X-Ray--E-Beam--Dosimeters--and-Combination-Products-with-Jeanne-Moldenhauer-e2d4mua

## Summary

Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting, explains the technical and regulatory nuances of irradiation sterilization for combination products, comparing gamma, e-beam, and x-ray modalities. She details how product density, material degradation (such as free radical formation), and bioburden levels dictate cycle development and dose selection. The discussion covers the shift toward terminal sterilization of finished auto-injectors and pre-filled syringes, highlighting the validation timelines and the critical role of dosimeters in ensuring sterility assurance levels (SAL).

## Chapters

- [0:02](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod#t=2) Introduction: Jeanne Moldenhauer and Irradiation Overview
- [2:49](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod#t=169) Sterilization Modalities: Gamma, E-Beam, and X-Ray
- [4:51](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod#t=291) Product Density and Cycle Development Factors
- [8:41](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod#t=521) Impact of Gamma on Drug Products and Materials
- [15:21](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod#t=921) Free Radicals, Material Degradation, and Literature Reviews
- [21:37](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod#t=1297) Bioburden, Verification Dose, and Sterility Assurance
- [26:53](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod#t=1613) Dosimeters and Dosimetric Release
- [31:29](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod#t=1889) Terminal Sterilization of Combination Products (Auto-injectors)
- [38:49](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-13-114-irradiation-sterilization-gamma-x-ray-e-beam-dosimeters-and-combination-prod#t=2329) Validation Process and Regulatory Timelines

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

early-stage companies

## Mentioned

- Excellent Pharma Consulting (company)
- Jeanne Moldenhauer (other)
- Subi Sedate (other)
- Baxter (company)
- Parenteral Drug Association (other)
- FDA (other)

## 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)
- [S6E51 Eric Richins | What It's Like Being A Packaging Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-12-19-s6e51-eric-richins-what-its-like-being-a-packaging-engineer) (Being an Engineer)
- [#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)

## Citing this page

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