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

 

 

Charlotte Masy

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.

 

 

Charlotte Masy

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.

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May 2021
Overcome Exosome Production Challenges

Biotech | Pall Corporation 웨비나 시리즈

This webinar was recorded by BioPharma Asia and first published on their website. https://biopharma-asia.com. It is made available here by kind permission of BioPharma Asia and the presenters. Scroll down to see a transcript of the webinar question and answer session.

 

Hailed as the “next frontier” in cell therapy and regenerative medicine, exosomes are a type of extracellular vesicle and play a key role in the regulation of the intercellular communication processes.

David Haylock of VivaZome will present on upstream production of angiogenic exosomes using the iCELLis® nano fixed bed bioreactor. This will be followed by a presentation by Roberto Ciboldi of Pall Corporation on a platform solution including cell culture, purification and sterile filtration of exosomes.

Participants will be able to:

 

  • Compare the performance of the iCELLis Nano bioreactor to traditional flasks for exosome production from adherent cell culture
  • Understand how an integrated end to end platform delivers highly   purified and consistently-sized exosomes
  • Discover an innovative cGMP scalable manufacturing platform for   exosomes
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