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Solvent Removal and Spore Inactivation Directly in Dispensing Vials with Supercritical Carbon Dioxide and Sterilant

A process is described using supercritical carbon dioxide to extract organic solvents from drug solutions contained in 30-mL serum vials. We report drying times of less than 1 h with quantitative recovery of sterile drug. A six-log reduction of three spore types used as biological indicators is achi...

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Detalhes bibliográficos
Main Authors: Howell, Jahna, Niu, Fengui, McCabe, Shannon E., Zhou, Wei, Decedue, Charles J.
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2012
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3364381/
https://ncbi.nlm.nih.gov/pubmed/22528546
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-012-9777-4
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