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HomeWebinarsHow a Helium Manufacturing Release Test Increases Integrity Assurance for Single-Use Assemblies

How a Helium Manufacturing Release Test Increases Integrity Assurance for Single-Use Assemblies



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

Monica Cardona

Merck

Senior Program Manager

Monica Cardona is a senior program manager for single-use and integrated systems at Merck. She has worked in life sciences for more than 20 years. She has had several global roles in technical, strategic, and operational marketing.

Monica holds a B.S. in Biology from Hofstra University and an M.S in Biology from Adelphi University. She has published and lectured internationally on a wide range of filtration, validation, and single-use bioprocessing topics. Monica is a member of the Parenteral Drug Association (PDA), BioPhorum, and a founding member of Bio-Process Systems Alliance (BPSA).

Chuck Raye

Chuck Raye

Merck

Product Manager, Final Fill Single Use Systems

Chuck Raye has 10+ years of experience in the bioprocessing industry, designing and validating 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 sterile filtration and aseptic filling applications. Chuck holds a B.S. in Mechanical Engineering from Syracuse University.