Schott is offering new sizes of its Vials DC (Delamination Controlled) range of glass vials from this month, which offer a reduced of delamination and decreased risk of product recalls to the pharmaceutical industry.
The company has added ISO sizes 6R and 8R to the 2R and 4R vials already available.
Delamination is the detachment of glass flakes from the inner glass surface of a pharmaceutical vial as a result of interaction with its contents. In response to the delamination issues surrounding the storage of pharmaceutical products in glass vials, Schott has combined high quality Fiolax glass tubing with an optimised hot forming process and a quantitative chemical glass surface test routine to develop these vials.
In the Schott Delamination QuickTest, a certain number of vials are removed from every batch. The random samples are then subjected to stress for four hours inside an autoclave to identify the delamination critical zone. In a second step, the vials are filled with high purity water (WFI – Water for Injection) and sodium is extracted inside an autoclave. The volume of sodium extracted correlates with the probability that the vials will experience delamination at a later point in time.
By monitoring these values and keeping to certain threshold values, Schott says it is able to control the risk of delamination.
The company says the improved manufacturing processes help to ensure the glass surface is more homogeneous and therefore less susceptible to delamination. An important consideration is that conventional tubular type I glass vials can simply be replaced by Schott Vials DC for authorised drugs, without costly re-registration.
