title: Evaluating ultraviolet sensitivity of adventitious agents in biopharmaceutical manufacturing.
abstract: Incidents of contamination in biopharmaceutical production have highlighted the need to apply alternative or supplementary disinfection techniques. Ultraviolet (UV) irradiation is a well-established method for inactivating a broad range of microorganisms, and is therefore a good candidate as an orthogonal technique for disinfection. To apply UV as a safeguard against adventitious agents, the UV sensitivity of these target agents must be known so that the appropriate dose of UV may be applied to achieve the desired level of inactivation. This document compiles and reviews experimentally derived 254 nm sensitivities of organisms relevant to biopharmaceutical production. In general, different researchers have found similar sensitivity values despite a lack of uniformity in experimental design or standardized quantification techniques. Still, the lack of consistent methodologies has led to suspicious UV susceptibilities in certain instances, justifying the need to create a robust collection of sensitivity values that can be used in the design and sizing of UV systems for the inactivation of adventitious agents.
authors.affiliation: Trojan Technologies, 3020 Gore Rd., London, ON, N5V 4T7, Canada.|Department of Chemical Engineering, Waterloo Institute for Nanotechnology, University of Waterloo, Waterloo, ON, N2L 3G1, Canada.
authors.forename: Sarah M
authors.initials: SM
authors.lastname: Meunier
authors.affiliation: Trojan Technologies, 3020 Gore Rd., London, ON, N5V 4T7, Canada. msasges@trojanuv.com.
authors.forename: Michael R
authors.identifier: 0000-0002-6150-2659
authors.initials: MR
authors.lastname: Sasges
authors.affiliation: Department of Chemical Engineering, Waterloo Institute for Nanotechnology, University of Waterloo, Waterloo, ON, N2L 3G1, Canada.
authors.forename: Marc G
authors.initials: MG
authors.lastname: Aucoin
mesh_terms: D001419:Bacteria / Q000528:radiation effects; D001702:Biopharmaceutics; D004203:Disinfection; D011836:Radiation Tolerance; D014466:Ultraviolet Rays; D014780:Viruses / Q000528:radiation effects
keywords: Adventitious agent; Biopharmaceutical; Disinfection; Irradiation; Ultraviolet; Viral clearance