Delamination, which is the formation of flakes in drug products owing to specific and
localized corrosion of glass vials, is a rare but serious problems, on which the FDA (US Food …

This paper is the result of two round robin activities run by the Technical Committee TC12,
Pharma Packaging, of the International Commission on Glass (ICG). It deals with the …

Delamination of flakes in glass containers used for primary drug packaging has become a
serious quality concern in recent years. Because glass delamination typically occurs …

Glass delamination has developed as a quality problem for primary packaging containers
over the last years. Beside other factors the container production process can contribute to …

Glass delamination is characterized by the dissociation of glass flakes from the glass
surface. Since glass delamination is time dependent, 5 vial types were investigated to …

Glass, even exceptionally inert Type I borosilicate glass, is susceptible to attack by
aggressive chemicals, causing it to spall. This phenomenon in primary packaging for …

The delamination of pharmaceutical glass is a serious issue, as it can cause glass particles
to appear in vials, a problem that has forced a number of drug product recalls in recent …

Primary packaging containers used for the storage of parenteral drugs are designed to
protect the medicinal product from the environment to ensure patient safety. Mainly …

An accelerated lamellae formation (ALF) methodology has been developed to determine the
delamination propensity and susceptibility of pharmaceutical glass vials. The ALF process …

Glass delamination has been at the forefront of the pharmaceutical industry since the FDA
published its advisory in 2011. The term delamination refers to the production of thin, visible …