Common Challenges in Designing Final Filtration
Regulatory agencies require biopharmaceutical manufacturers to thoroughly understand and control their final filtration processes. Furthermore, in the EU GMP Annex 1, they provide specific instructions covering how to perform integrity tests on sterilizing filters, both pre-use/post sterilization (PUPSIT) and post-use. Manufacturers, vendors and industry stakeholder associations have worked diligently to understand the risks, requirements and mitigation measures needed to design processes and equipment to meet these regulatory demands and, more importantly, protect patients.
Single-use solutions are ideally suited for final filtration and PUPSIT applications, and standardized assemblies and holders deliver a number of advantages. In this webinar, our experts will explain the basics of PUPSIT requirements and review how standardized, single-use filter assemblies free biopharmaceutical from much of the major design, engineering, qualification and risk mitigation activities in final filtration. They will also introduce Sartorius’ final filtration solutions and describe how they are unique in the industry.
- Review the common challenges encountered when performing final filtration and PUPSIT.
- Understand PUPSIT and how to implement it more efficiently in final filtration applications.
- Summarize the benefits of using a plug-and-play solution for final filtration and PUPSIT.
Meet Our Experts:
Lucia Dinehart
Product Specialist of Filter Transfer Sets
Lucia has been working for Sartorius for over 8 years and currently is a Product Specialist responsible for providing technical support and expertise in the field of single-use solutions focusing on filter transfer sets. She has over 20 years of experience supporting biotech manufacturing and has worked for GE Healthcare and Amersham Biosciences supporting large-scale chromatography applications. She was also a senior scientist at the Monoclonal Antibody/Hybridoma Core Facility at University of Florida’s Interdisciplinary Center for Biotechnology Research.
Sven Linz
Product Manager of Confidence® Validation Services
Sven Linz is the Product Manager of Confidence® Validation Services since January 2020. He holds a Master’s degree in Marketing, Energy, and Process Engineering. Sven has gained first-hand marketing experience while working for an international startup accelerator based in San Juan, Puerto Rico. In addition, he has been working as a management consultant with a focus on organizational development of an R&D department at Volkswagen.