Navpreet Kaur, Apurva More, Jacob McKeeby, Ragaleena Vanipenta, Fenil Patel, Mary Kish, Dimitrios Pelekoudas, Alexandre Piquenot, Mostafa Nakach, Timothy R McCoy, Lauren Fontana, Atul Saluja
A commonly encountered challenge with freeze-dried drug products is glass vial fogging. Fogging is characterized by a thin layer of product deposited upon the inner surface of the vial above the lyophilized cake. While considered to be a routine cosmetic defect in many instances, fogging around the shoulder and neck of the vial may potentially impact container closure integrity and reject rates during inspection. In this work, the influence of processing conditions i.e. vial pre-treatment, lyophilization cycle modifications and filling conditions on fogging was evaluated...
March 29, 2024: Journal of Pharmaceutical Sciences