How a Helium Manufacturing Release Test Increases
WEBINAR
Helium integrity testing is an industry-proven test that detects defects in single-use systems. This sensitive test reduces the risk of leaks or microbial ingress into manufacturing processes so manufacturers can be confident their entire systems, including tubing and connection points, are integral. This is especially critical during freezing, thawing, transportation, and storage. This webinar will describe the development and validation of the helium integrity test and demonstrate how it can benefit critical single-use process steps.
In this webinar, you will learn:
- Different approaches for integrity testing single-use systems
- The benefits of the helium integrity test for increased integrity assurance in critical single-use systems
Speakers
Monica Cardona
Merck
Global Senior Program Manager- Single Use & Integrated Platform Solutions
Monica Cardona is senior program manager for single-use and integrated platform solutions at our company, with 20+ years in life sciences across technical, strategic, and operational marketing roles. She leads cross-functional portfolio enhancement programs with quality, Emprove®, regulatory, operations, R&D, and commercial teams. She holds a B.S. from Hofstra and an M.S. from Adelphi, and is an active author, speaker, and industry member (PDA, BioPhorum, BPSA board).
Chuck Raye
Merck
Senior Strategic Product Manager, Single-use Fill Finish Products
Chuck Raye has 14 years of experience in the bioprocessing industry, designing, validating, and managing single-use (SU) components and systems. He has also supported operational teams in the manufacturing of SU systems. In his current role, he works directly with customers, R&D, and operations to develop solutions that advance SU technology in the fill finish processes of sterile filtration and filling. Chuck holds a B.S. in mechanical engineering from Syracuse University.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:45min
Language:English
Session 1:presented March 31, 2022