Common Challenges in Designing Final Filtration
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admin
작성일
2022-03-03 17:22
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7811
[ Webinar ]
Common Challenges in Designing Final Filtration
[ Overview ]
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
What You Will Learn
- 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.