# 080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-04-12
- Length: 25m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-12-080-9-cci-tests-in-10-minutes-probabilistic-vs-deterministic-and-cci-vs-permeati
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/080---9-CCI-Tests-in-10-Minutes--Probabilistic-vs--Deterministic--and-CCI-vs--Permeation-with-Derek-Duncan-e2221ul

## Summary

Derek Duncan, Director and VP of Product Management at Lighthouse Instruments, explains the distinction between deterministic and probabilistic Container Closure Integrity (CCI) testing methods as defined in USP 1207. He details nine specific CCI technologies, including helium leak testing, headspace analysis, and vacuum decay, highlighting their sensitivity, destructiveness, and suitability for 100% production inspection. Duncan also clarifies the critical difference between CCI breaches, which pose sterility risks, and gas permeation through materials like rubber stoppers, which occurs over shelf life without compromising sterility.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-12-080-9-cci-tests-in-10-minutes-probabilistic-vs-deterministic-and-cci-vs-permeati#t=0) Introduction: Subi Sedate and Derek Duncan at Lighthouse Instruments
- [2:12](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-12-080-9-cci-tests-in-10-minutes-probabilistic-vs-deterministic-and-cci-vs-permeati#t=132) History of Lighthouse Instruments and Laser Spectroscopy
- [3:07](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-12-080-9-cci-tests-in-10-minutes-probabilistic-vs-deterministic-and-cci-vs-permeati#t=187) Deterministic vs. Probabilistic CCI Methods in USP 1207
- [6:27](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-12-080-9-cci-tests-in-10-minutes-probabilistic-vs-deterministic-and-cci-vs-permeati#t=387) 100% Inspection vs. QC Validation and EU Annex One Requirements
- [11:40](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-12-080-9-cci-tests-in-10-minutes-probabilistic-vs-deterministic-and-cci-vs-permeati#t=700) Overview of 9 CCI Test Methods: Microbial, Bubble, and Helium
- [15:12](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-12-080-9-cci-tests-in-10-minutes-probabilistic-vs-deterministic-and-cci-vs-permeati#t=912) Headspace Analysis, Pressure/Vacuum Decay, and HVLD
- [19:22](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-12-080-9-cci-tests-in-10-minutes-probabilistic-vs-deterministic-and-cci-vs-permeati#t=1162) Distinguishing CCI Breaches from Gas Permeation and Sterility

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

established companies

## Mentioned

- Lighthouse Instruments (company)
- USP 1207 (other)
- Annex One (other)
- Helium Leak Test (tool)
- Headspace Analysis (tool)
- Vacuum Decay (tool)
- High Voltage Leak Detection (tool)
- Microbial Ingress Testing (tool)
- Bubble Emission Test (tool)

## 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/2023-04-12-080-9-cci-tests-in-10-minutes-probabilistic-vs-deterministic-and-cci-vs-permeati. 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.