Implementation of Safe Pre-Use Post-Sterilization Integrity Test (PUPSIT) on Filters in Single-Use Assemblies
Implementation of Safe Pre-Use Post-Sterilization Integrity Test (PUPSIT) on Filters in Single-Use Assemblies
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
Moderator: Hélène Pora
VP Technical Communication & Regulatory Strategy
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.
Presenter: Alain Vanhecke
Pall Biotech
Senior Technical Specialist
Alain Vanhecke is a senior technical specialist for Pall Biotech based in Hoegaarden, Belgium. With over 33 years of experience in the bioprocessing industry, Alain is a critical driver of the extensive support program Pall provides for customers. He is responsible for multiple facets of integrating the bioprocess portfolio with scientific and laboratory services, including process development for strategic accounts and technical field support for the single-use technology portfolio in the European and Western regions.
Learn more about the Helium Integrity Test
Manage risk in your critical process with this high sensitivity, supplier integrity test for single-use systems, filling sets and mixer biocontainers.
Biotech | 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