Integrated Lifecycle Approach for Deterministic Container Closure Integrity in Biopharmaceuticals

Tuesday, October 22, 2024

11:00 AM – 12:00 PM MT

Location:360 Stage #2, Exhibit Hall

Sponsored By

Manufacturing and Analytical Characterization

Partner Presentation-Manufacturing & Bioprocessing

Partner Presentation Speaker(s)

MD

Michael Dominguez (he/him/his)

Container Closure Systems and Medical Device Manager
Kindeva Drug Delivery
Woodbury, Minnesota

Description: Explore an integrated lifecycle strategy for Container Closure Integrity (CCI) in sterile biopharmaceutical products. Learn how deterministic methods aligned with USP < 1207> ensure robust integrity from package processing to commercial stability, utilizing advanced techniques like Residual Seal Force, Helium Tracer Gas detection, and Laser-Based Oxygen Headspace Analysis

Learning Objectives:

Understand the importance of an integrated lifecycle approach to CCI in maintaining product quality.
Learn how deterministic CCI test methods align with USP standards throughout the product lifecycle.
Explore the application and benefits of advanced CCI techniques, including RSF, Helium Tracer Gas detection, and Laser-Based Oxygen Headspace Analysis.