# 083 - Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-05-03
- Length: 27m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-03-083-holistic-approach-to-container-closure-integrity-capping-crimping-rsf-and-an
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/083---Holistic-Approach-to-Container-Closure-Integrity--CappingCrimping--RSF--and-Annex-IUSP-1207-Requirements-with-Derek-Duncan-e23938p

## Summary

Derek Duncan, Director and VP of Product Management at Lighthouse Instruments, explains the 'holistic approach' to Container Closure Integrity (CCI) testing for sterile pharmaceutical products. He details how risk management strategies dictate testing intensity, contrasting the robust data needs for lyophilized and ultra-cold products with standard liquid fills. Duncan also clarifies the relationship between EU Annex I and USP 1207 regulations, emphasizing the shift toward science-based, deterministic analytical methods over subjective visual inspections.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-03-083-holistic-approach-to-container-closure-integrity-capping-crimping-rsf-and-an#t=0) Introduction and CCI Fundamentals
- [1:51](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-03-083-holistic-approach-to-container-closure-integrity-capping-crimping-rsf-and-an#t=111) The Holistic Approach to CCI
- [5:10](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-03-083-holistic-approach-to-container-closure-integrity-capping-crimping-rsf-and-an#t=310) Risk Management and Testing Strategy
- [7:45](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-03-083-holistic-approach-to-container-closure-integrity-capping-crimping-rsf-and-an#t=465) Lyophilized and Ultra-Cold Product Risks
- [12:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-03-083-holistic-approach-to-container-closure-integrity-capping-crimping-rsf-and-an#t=720) Residual Seal Force and Capping/Crimping
- [15:38](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-03-083-holistic-approach-to-container-closure-integrity-capping-crimping-rsf-and-an#t=938) EU Annex I vs. USP 1207 Requirements
- [19:23](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-03-083-holistic-approach-to-container-closure-integrity-capping-crimping-rsf-and-an#t=1163) Dynamic Devices and Future Trends

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)

## Most relevant to

established companies

## Mentioned

- Lighthouse Instruments (company)
- Pfizer (company)
- EU Annex I (other)
- USP 1207 (other)
- Residual Seal Force (other)

## Related episodes from other shows

- [#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)

## 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/2023-05-03-083-holistic-approach-to-container-closure-integrity-capping-crimping-rsf-and-an. 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.