International journal of pharmaceuticsDrug PackagingFreeze DryingGlassPharmaceutical Preparations
Does fogging impact container closure integrity for a lyophilized drug product?
Markela Ibo Murphy, Sajal M Patel, Mohsina Rahman, Ben Hong, Sandra Plata Lee, Andrea Allmendinger, Hanns-Christian Mahler
Published: 202610.1016/j.ijpharm.2025.126452
Abstract
The impact of fogging on container closure integrity (CCI) in lyophilized drug products in glass vials was investigated. Fogging occurs when the drug solution moves above the intended fill level on the side, shoulder, or neck of the vial and dries, r…
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