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 look for solutions to industrialize its usage in a safe and reliable way.
With single-use systems (SUS) 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.
In this webinar, the fundamental principles of Quality Risk Management (QRM) applied to SUS adoption and validation will be discussed. In addition, participants will gain an in-depth understanding of how to define an integrity strategy for their critical SUS, as well as on how to safely Pre-Use Post Sterilization Integrity Test (PUPSIT) filters in SUS. By the conclusion of the session, all attendees should be able to define a risk mitigation strategy for SUS.
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.
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.
Request a demo
See how fast and simple filter integrity testing can be!
¡Todo sobre los ensayos de validaciones para cumplir con los máximos estándares regulatorios!
Hablaremos sobre puntos cruciales de los servicios de validación, incluyendo:
1. Necesidad de validación
2. Cómo se realizan los ensayos de validación
3. Análisis de riesgo: re uso de filtros y toma de decisión en ensayos a realizar
4. Servicio de Validación Pall: documentación requerida para iniciar una cotización
¡No pierdas esta segunda oportunidad!