Diane M McCormick, Evgeniia Vorozhbit, Steve Nail, Alina Alexeenko, NIPRO
Extreme temperatures necessary in the glass converting process causes sublimation of glass components. Consequently, these components re-sublimate on the glass surface causing a structural change of the very inner glass surface layer. An altered inner glass surface layer leaves drugs at a high risk of increased of defects such as fogging during the lyophilization process.With this presentation, we provide new data on innovative technology that yields exceptional inner surface conditions for lyophilized drugs. Focus will be on the behavior of the inner glass surface during lyophilization.