This presentation will provide a comprehensive review of the different virus retention behaviors, and mechanisms, for two parvovirus filters. The same conditions that cause virus breakthrough, for these two parvovirus filters, apply to all parvovirus filters. It is only the degree of the impact that differs for each specific filter type. This is explained by the fact that each virus filter has a unique material of construction, membrane morphology, and membrane pore size distribution. This presentation will also review the relative virus retention behaviors of other virus filter types in studies where they were tested all together. The primary objective is to discuss worst case conditions and critical parameters for parvovirus filters in general. This is a very important and timely discussion to have now, with over two decades of experience running these filters. It is important for filter suppliers, filter users, and regulators to have this open discussion and clarify what is and is not critical for any specific virus filter, so the process can be effectively validated and controlled. A proposed option for a single standard validation test method will be described, one that includes all of the virus breakthrough causing conditions in one test. This agreed upon single standard validation test method, with agreed upon reasonable worst-case endpoints, would make the validation process more predictable and efficient, and improve safety when it comes to all virus filter types, and be more transparent for everyone. All would know what needs to be tested and why, and what reasonable worst-case endpoints should be used.

Proposed standard virus filter validation method: One that covers all worst-case conditions in a single test

ACS Fall 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.