# 086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with ⁠Fran DeGrazio⁠

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-05-24
- Length: 30m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-24-086-elastomers-stopper-and-plunger-manufacturing-processing-and-usp-381-382-with
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/086---Elastomers---Stopper-and-Plunger-Manufacturing--Processing-and-USP-381382-with-Fran-DeGrazio-e24j1mg

## Summary

Fran DeGrazio, President & Principal Consultant at Strategic Parenteral Solutions and former Chief Scientific Officer at West Pharmaceuticals, explains the manufacturing and processing of elastomeric stoppers and plungers for injectable drug products. She details the differences between uncoded, coated, and laminated components, the specific challenges of silicone oil migration, and the distinction between compression molding and injection molding for rubber. DeGrazio also clarifies the regulatory landscape, specifically the split of USP <381> into <381> and <382> and the role of ISO standards in global harmonization.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-24-086-elastomers-stopper-and-plunger-manufacturing-processing-and-usp-381-382-with#t=0) Introduction and Nomenclature Confusion
- [2:19](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-24-086-elastomers-stopper-and-plunger-manufacturing-processing-and-usp-381-382-with#t=139) Machinability and Component Types
- [4:30](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-24-086-elastomers-stopper-and-plunger-manufacturing-processing-and-usp-381-382-with#t=270) Uncoded, Coated, and Laminated Variations
- [8:27](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-24-086-elastomers-stopper-and-plunger-manufacturing-processing-and-usp-381-382-with#t=507) Silicone Oil Issues and Polymerized Coatings
- [14:16](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-24-086-elastomers-stopper-and-plunger-manufacturing-processing-and-usp-381-382-with#t=856) Compression Molding vs. Injection Molding
- [21:19](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-24-086-elastomers-stopper-and-plunger-manufacturing-processing-and-usp-381-382-with#t=1279) Washing, Sterilization, and Lamination Processes
- [26:12](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-24-086-elastomers-stopper-and-plunger-manufacturing-processing-and-usp-381-382-with#t=1572) USP <381>/<382> and Global Standards

## Topics

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

## Most relevant to

established companies

## Mentioned

- Strategic Parenteral Solutions (company)
- West Pharmaceuticals (company)
- USP <381> (other)
- USP <382> (other)
- ISO 15378 (other)
- USP <1663> (other)
- USP <1664> (other)
- EP 3.2.9 (other)

## Related episodes from other shows

- [S5E12 Dylann Ceriani | Prototype Injection Molding](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-03-22-s5e12-dylann-ceriani-prototype-injection-molding) (Being an Engineer)
- [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)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)
- [UDI and the Current State of Global Implementation](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-18-udi-and-the-current-state-of-global-implementation) (Global Medical Device Podcast)

## Citing this page

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