Integrity of Single-Use Systems

Integrity of Single-Use Systems

Single-use technologies (SUT) have evolved into commercial operations, and drug manufacturers are looking for solutions to industrialize their usage in a safe and reliable way.

With SUT adoption, quality ownership involves shared responsibilities between supplier and end user. Additional parts of the supply and quality chain shift to supplier.

Join us as we present existing good practices to ensure critical quality attributes (CQAs) of the SUS throughout their life cycle.

Participants will learn:

  • How to implement and validate SUS using Quality Risk Management (QRM)
  • Define a reliable integrity strategy for SUS
  • Pre-Use Post Sterilization Integrity Test (PUPSIT) for filters in SUS
  • Simplify validation and toxicological assessment using standardized extractable data sets

Speaker

 

 

Hélène Pora

VP Technical Communication & Regulatory Strategy
Pall Biotech

 

Hélène has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation.

 

She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.

 

 

Patrick Evrard

 

Senior Principle Engineer
Pall Biotech

 

 

Patrick Evrard joined Pall Biotech in 2017, as Senior Director, SLS Single-Use Technologies, to manage the technical team providing expert technical support to Pall Biotech's customers. Before joining Pall, he led for more than 10 years a global technical team in charge of developing and implementing single-use technologies in GSK Vaccines' commercial manufacturing operations. Patrick and his team implemented at global level single-use technologies in critical sterile applications and re-engineered several vaccines processes, switching from classical grade A open processes to closed systems.

White paper: A risk based approach to validation studies for sterilizing filtration. Download Now.

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April 2022
Getting Ready for SUT X-Ray Irradiation

Biotech Research & Commercialization Solutions | Pall Corporation webinar series

Why the introduction of X-ray sterilization technology is a critical change for single-use industry, and how gamma and X-ray irradiation compare

 

The market demand for gamma irradiation, the current primary method for the sterilization in SUT, will soon significantly exceed supply, creating an urgent need for alternatives.

 

Join Christelle Marcoux from GSK Vaccines (BioPhorum workstream member on alternatives to gamma sterilization) and James Hathcock, PhD of Pall Corporation (Bio-Process Systems Alliance X-Ray Committee Co-Chair) as they discuss the introduction of X-ray sterilization technology.

 

You will learn more about:

 

  • Why this is a critical change for industry and the responsibilities of each stakeholder
  • Key questions to address for biomanufacturers
  • How gamma and X-ray irradiation compare
  • What testing has been completed and key milestones for readiness for industry
  • An example of how to qualify a SUS sterilized with X-ray irradiation
Watch