Delamination is defined as the peeling of inorganic flakes from the inner glass surface of a pharmaceutical vial as a result of interaction with its contents. This issue remains a top priority for pharmaceutical drug manufacturers with aggressive or high pH value drug products as delamination of vials has resulted in very costly drug recalls, which has led to the FDA advising that pharmaceutical companies look into how this issue affects their products.
This has led SCHOTT to develop a highly optimised vial to mitigate this risk, a product known as SCHOTT® Vials DC (DC = delamination controlled).
SCHOTT Vials DC combine an optimised production process with a reliable chemical test procedure.
During their investigation, SCHOTT identified that delamination occurs in vials at the points of vial forming, especially where the bottom of the vial is formed. Volatile components, such as boron and sodium evaporate at the forming sites due to the high levels of heat used to form the vial shape. These elements then go on to form inhomogeneous spots on the glass surface, especially near the bottom of the vial, where they show a higher tendency to delaminate.
SCHOTT® Vials DC are produced with an improved production process which helps to ensure that the glass surface is more homogeneous and therefore less susceptible to delamination.
To confirm this effect, SCHOTT conducted storage studies with systems that showed a high tendency toward delamination while using standard Type I vials. The results showed that SCHOTT® Vials DC remained stable even after eight weeks of storage involving a 15 percent potassium chloride solution and a 10 percent sodium thiosulphate solution at a temperature of 60° C, while conventionally manufactured vials showed clear initial signs of delamination.
The high inner glass surface homogeneity decreases the tendency for delamination especially at the bottom near delamination risk zone.
The product quality is routinely inspected by the patented SCHOTT Delamination Quicktest.
Conventional SCHOTT vials can be easily replaced by SCHOTT Vials DC without re-registration because of an unchanged glass composition and glass surface.
SCHOTT® Vials DC will be available in the ISO formats 2R to 10R (2 to 10 ml) starting at the beginning of 2014.