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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September 2020

From September 22nd to November 19th

 

There is no single vaccine manufacturing approach. There are, however, flexible technologies that can meet each of the challenges during process development and at GMP scale.

 

Accelerating vaccine development and manufacturing by coupling research advances in vaccine technology with systems that support agility through a Quality by Design approach is critical to deliver life-saving immunizations to those in need globally.

 

Diversity in the type of vaccine antigen, along with the inherent variation in the targets, have created challenges for vaccine manufacturers when compared to a relatively small number of platform processes that exist.

 

There are flexible technologies that can meet each of the challenges during PD and at GMP scale.

 

Join this webinar series and learn more about securing process quality with flexible manufacturing solutions.

 

Webinars available

 

  • Vaccines development, regulations and manufacturing Parts 1 & 2

 

  • Developing scalable upstream workflows for recombinant and viral vaccine processes

 

  • Downstream process development for vaccine manufacturing

 

  • Implementing single-use technologies in formulation and filling of vaccines
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