Let's Combinate - Drugs + Devices

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


Listen Later

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system and the impact of sterilization processes on functionality. Fran also discusses the scope of USP 382, covering vials, syringes, pens, IV bags, and blow-fill-seal containers, emphasizing the need for harmonization with ISO standards. The episode highlights the necessity for pharmaceutical sponsors to generate data on the system to comply with USP 382 and prepare for its 2025 implementation.

00:00 Introduction to the Combinate Podcast
01:08 Understanding USP 382 and Its Importance
01:41 Differences Between USP 381 and USP 382
03:50 Challenges and Responsibilities in Compliance
07:49 Impact of Sterilization on Stoppers
11:11 Upcoming Changes and Industry Adaptation
15:21 Functional Performance Tests and System Understanding
19:04 Broader Scope: IV Bags and Alternative Packaging
21:33 Conclusion and Contact Information

Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals. She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products.


Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas. DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018.


Frankly Fran Newsletter: https://www.drugdeliveryleader.com/doc/setting-the-bar-for-drug-product-quality-part-the-evolving-practice-of-particle-testing-0001

...more
View all episodesView all episodes
Download on the App Store

Let's Combinate - Drugs + DevicesBy Subhi Saadeh

  • 4.9
  • 4.9
  • 4.9
  • 4.9
  • 4.9

4.9

13 ratings


More shows like Let's Combinate - Drugs + Devices

View all
Marketplace by Marketplace

Marketplace

8,625 Listeners

Fresh Air by NPR

Fresh Air

37,873 Listeners

Planet Money by NPR

Planet Money

30,725 Listeners

Global Medical Device Podcast powered by Greenlight Guru by Greenlight Guru + Medical Device Entrepreneurs

Global Medical Device Podcast powered by Greenlight Guru

91 Listeners

The Daily by The New York Times

The Daily

110,824 Listeners

Up First from NPR by NPR

Up First from NPR

55,990 Listeners

The Indicator from Planet Money by NPR

The Indicator from Planet Money

9,502 Listeners

SmartLess by Jason Bateman, Sean Hayes, Will Arnett

SmartLess

57,301 Listeners

The Ezra Klein Show by New York Times Opinion

The Ezra Klein Show

15,363 Listeners