# 119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-01-18
- Length: 26m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-18-119-what-are-the-basics-of-clean-rooms-rabs-and-isolators-in-iso14644-and-eu-ann
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/119---What-are-the-basics-of-Clean-Rooms--RABS-and-Isolators-in-ISO14644-and-EU-Annex-I--with-David-Simoens-e2ehle9

## Summary

David Simoens, founder of Life Science Professionals, explains the technical and regulatory differences between isolators and RABS in sterile manufacturing. He details how Annex I and ISO 14644 standards dictate pressure cascades, background environments, and the shift toward isolators to minimize operator intervention. Simoens discusses the specific classifications of these systems and the importance of contamination control strategies for both cytotoxic and sterile products.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-18-119-what-are-the-basics-of-clean-rooms-rabs-and-isolators-in-iso14644-and-eu-ann#t=0) Introduction and Guest Background
- [3:28](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-18-119-what-are-the-basics-of-clean-rooms-rabs-and-isolators-in-iso14644-and-eu-ann#t=208) Regulatory Standards: Annex I and ISO 14644
- [6:35](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-18-119-what-are-the-basics-of-clean-rooms-rabs-and-isolators-in-iso14644-and-eu-ann#t=395) Pressure Cascades: Sterility vs. Containment
- [14:29](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-18-119-what-are-the-basics-of-clean-rooms-rabs-and-isolators-in-iso14644-and-eu-ann#t=869) Isolators vs. RABS: Operator Risk and Intervention
- [18:05](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-18-119-what-are-the-basics-of-clean-rooms-rabs-and-isolators-in-iso14644-and-eu-ann#t=1085) Technical Definitions and Classifications of Isolators and RABS
- [22:40](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-18-119-what-are-the-basics-of-clean-rooms-rabs-and-isolators-in-iso14644-and-eu-ann#t=1360) Background Environments and Learning Resources

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- Life Science Professionals (company)
- Annex I (other)
- ISO 14644 (other)
- RABS (tool)
- Isolators (tool)

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- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)
- [Ajay Panwar | Statistical Control Processes, Regression Analysis, and Philanthropy](https://hardwarepodcasts.com/podcast/being-an-engineer/2022-03-18-ajay-panwar-statistical-control-processes-regression-analysis-and-philanthropy) (Being an Engineer)

## Citing this page

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