# 153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-09-11
- Length: 21m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-11-153-usp-382-elastomeric-component-functional-suitability-delivery-systems-spikes
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/153---USP-382--Elastomeric-Component-Functional-Suitability--Delivery-Systems--Spikes--IV-Bags-and-Alternate-Packaging-with-Fran-Degrazio-e2o8khh

## Summary

Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and former Chief Scientific Officer at West Pharmaceuticals, explains the transition from USP <381> to USP <382>, which shifts the focus from isolated component testing to evaluating elastomeric closures as part of a functional system. She details how sterilization processes like steam and gamma radiation impact rubber integrity and why pharmaceutical sponsors must now generate system-level data to ensure compliance by the December 2025 effective date. Degrazio also discusses the importance of harmonizing with ISO standards and addressing functional challenges such as spike penetration and push-in in vial, syringe, and IV bag systems.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-11-153-usp-382-elastomeric-component-functional-suitability-delivery-systems-spikes#t=0) Introduction and USP 382 Overview
- [1:41](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-11-153-usp-382-elastomeric-component-functional-suitability-delivery-systems-spikes#t=101) Differences Between USP 381 and 382
- [4:36](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-11-153-usp-382-elastomeric-component-functional-suitability-delivery-systems-spikes#t=276) System-Level Compliance and Supplier Roles
- [7:48](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-11-153-usp-382-elastomeric-component-functional-suitability-delivery-systems-spikes#t=468) Impact of Sterilization on Elastomers
- [11:11](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-11-153-usp-382-elastomeric-component-functional-suitability-delivery-systems-spikes#t=671) Implementation Timeline and Harmonization
- [15:21](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-11-153-usp-382-elastomeric-component-functional-suitability-delivery-systems-spikes#t=921) Functional Tests and Spike Challenges
- [19:04](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-11-153-usp-382-elastomeric-component-functional-suitability-delivery-systems-spikes#t=1144) Broader Scope: IV Bags and Alternative Packaging

## Topics

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

## Most relevant to

established companies

## Mentioned

- USP <381> (other)
- USP <382> (other)
- USP <1382> (other)
- West Pharmaceuticals (company)
- Strategic Parenteral Solutions (company)
- ISO (other)
- FDA (company)

## 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)
- [#446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu) (Global Medical Device Podcast)
- [#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech) (Global Medical Device Podcast)
- [EUA and the Impending Transition](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition) (Global Medical Device Podcast)
- [323 - Nerding Out on Medical Packaging & Ditching PVC with Keith Smith of Vonco](https://hardwarepodcasts.com/podcast/people-of-packaging/2025-09-08-323-nerding-out-on-medical-packaging-ditching-pvc-with-keith-smith-of-vonco) (People of Packaging)

## Citing this page

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