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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-11-29
- Length: 47m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-29-112-steam-sterilization-moist-dry-heat-biological-indicators-cycle-development-v
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/112---Steam-Sterilization--MoistDry-Heat--Biological-Indicators--Cycle-Development--Validation-and-Parametric-with-Release-with-Jeanne-Moldenhauer-e2cgf1j

## Summary

Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting, explains the technical nuances of steam and dry heat sterilization for pharmaceutical and combination products. She details the selection of biological indicators like Geobacillus stearothermophilus and Bacillus smithi, noting how solution chemistry and surface contact alter their heat resistance. The discussion covers the distinction between overkill and product-specific cycles, the calculation of F0 values, and the historical shift toward parametric release to accelerate product availability.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-29-112-steam-sterilization-moist-dry-heat-biological-indicators-cycle-development-v#t=0) Introduction: Jeanne Moldenhauer and Excellent Pharma Consulting
- [2:11](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-29-112-steam-sterilization-moist-dry-heat-biological-indicators-cycle-development-v#t=131) History of Moist Heat and Dry Heat Sterilization
- [8:21](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-29-112-steam-sterilization-moist-dry-heat-biological-indicators-cycle-development-v#t=501) Biological Indicators and Microorganism Resistance
- [14:48](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-29-112-steam-sterilization-moist-dry-heat-biological-indicators-cycle-development-v#t=888) BI Placement, Surface Contact, and Solution Effects
- [20:42](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-29-112-steam-sterilization-moist-dry-heat-biological-indicators-cycle-development-v#t=1242) Overkill vs. Product-Specific Cycles
- [28:53](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-29-112-steam-sterilization-moist-dry-heat-biological-indicators-cycle-development-v#t=1733) Cycle Parameters, F0 Calculation, and Penetration
- [37:07](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-29-112-steam-sterilization-moist-dry-heat-biological-indicators-cycle-development-v#t=2227) Parametric Release and the Limitations of Sterility Testing

## Topics

- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

established companies

## Mentioned

- Excellent Pharma Consulting (company)
- Parenteral Drug Association (company)
- Geobacillus stearothermophilus (other)
- Bacillus smithi (other)
- Burkholderia cepacia (other)
- Baxter (company)
- FDA (company)
- USP (other)
- EP (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)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-29-112-steam-sterilization-moist-dry-heat-biological-indicators-cycle-development-v. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.