by Glen Bolton, Jason Cormier, Mani Krishnan, John Lewnard, and Herbert Lutz
Volume 5, Issue 1 (Spring 2006)
Manufacturers must demonstrate, with a very high degree of assurance, that biopharmaceutical products derived from mammalian cells or from human plasma are safe and free of viral contamination. Viruses can be physically removed from most proteins using filtration. Often air diffusion is used as a nondestructive test to ensure that a process filter is installed properly and free of defects that can compromise virus retention. In this article, theoretical models were used to relate air and liquid flow rates through integral and defective filters. The effect of defect diameter and defect density on the virus retentive ability of a filter was also modeled…
Citation:
Bolton G, Cormier J, Krishnan M, Lewnard J, Lutz H. Integrity Testing of Normal Flow Parvovirus Filters Using Air-Liquid Based Tests. BioProcess J, 2006; 5(1): 52-57. https://doi.org/10.12665/J51.Bolton