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 …

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 …

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 …

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

Delamination, or the generation of glass flakes in vials used to contain parenteral drug
products, continues to be a persistent problem in the pharmaceutical industry. To …

Purpose: Studies were initiated to examine the effect of formulation and process variables
on the delamination process and also the influence of the glass manufacturing process …

The occurrence of glass delamination is a serious concern for parenteral drug products.
Over the past several years, there has been a series of product recalls involving glass …