# Packaging Validation Best Practices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-09-07
- Length: 37m
- Episode: 279
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices
- Listen: https://podcast.greenlight.guru/episode/packaging-validation-best-practices

## Summary

Jeff Barrett, CEO of J-Pac Medical, explains the complexities of ISO 11607 packaging validation for sterilized medical devices, emphasizing that over a third of validations fail transit testing due to a lack of understanding regarding shipping modes. He details how companies can avoid costly 510(k) delays by conducting feasibility testing, using worst-case scenarios for sterilization, and managing labeling risks, which account for 40% of FDA recalls. Barrett highlights that sterilization validations can cost $40,000-$80,000 and take 16-20 weeks, urging engineers to integrate packaging design early in the process to prevent revalidation issues as companies scale.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=0) Introduction: Jeff Barrett and J-Pac Medical
- [2:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=158) J-Pac Medical's Turnkey Packaging Services
- [5:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=308) ISO 11607 Standards and Timeline Expectations
- [7:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=437) Packaging System Design and Sterile Transfer
- [10:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=635) Feasibility Testing and Transit Failure Rates
- [13:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=816) Worst-Case Scenarios and Dummy Parts
- [15:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=934) Root Causes of Packaging Validation Failures
- [18:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=1087) Sterilization Validation Costs and Scales
- [20:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=1239) Worst-Case Sealing and 2X Sterilization
- [26:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=1597) Labeling Risks and FDA Recalls
- [27:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=1678) Integrity and Strength Testing Methods
- [31:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices#t=1862) Separating Product and Package Aging

## Topics

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

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- J-Pac Medical (company)
- ISO 11607 (other)
- FDA (other)
- 510(k) (other)
- Green Light Guru (company)
- ASTM (other)

## Related episodes from other shows

- [70 - Charlie Webb from Van Der Stahl Scientific](https://hardwarepodcasts.com/podcast/people-of-packaging/2021-08-19-70-charlie-webb-from-van-der-stahl-scientific) (People of Packaging)
- [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)
- [249 - Cali compostabull and Pistakio Packaging 911](https://hardwarepodcasts.com/podcast/people-of-packaging/2024-03-14-249-cali-compostabull-and-pistakio-packaging-911) (People of Packaging)
- [127 - "If we do our job, no one will know" with LeRonda Perry](https://hardwarepodcasts.com/podcast/people-of-packaging/2022-04-27-127-if-we-do-our-job-no-one-will-know-with-leronda-perry) (People of Packaging)
- [Ep. 30 - Avoiding Packaging Mistakes](https://hardwarepodcasts.com/podcast/open-hardware-manufacturing-podcast/2024-10-10-ep-30-avoiding-packaging-mistakes) (Open Hardware Manufacturing Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-07-packaging-validation-best-practices. 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 Global Medical Device Podcast.