SCHOTT Pharmaceutical Systems presents expanded portfolio on SCHOTT Vials DC
SCHOTT has combined high quality FIOLAX® glass tubing with an optimized hot forming process and a quantitative chemical glass surface test routine to develop SCHOTT Vials DC. The improved manufacturing processes help to ensure the glass surface is more homogeneous and therefore less susceptible to delamination.
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 optimized hot forming process and a quantitative chemical glass surface test routine to develop SCHOTT Vials DC. The improved manufacturing processes help to ensure the glass surface is more homogeneous and therefore less susceptible to delamination. Importantly, conventional tubular type I glass vials can simply be replaced by SCHOTT Vials DC for authorized drugs, without costly re-registration. Just recently, the company has expanded its portfolio of SCHOTT Vials DC to include ISO sizes 6R and 8R in addition to the 2R and 4R vials already available.
SCHOTT is also the first manufacturer capable of determining the risk of delamination based on threshold values, and then monitoring these values over the course of manufacturing. To achieve this, the company developed a patented Quicktest. In the past, the vials had to be examined very carefully with a stereomicroscope during testing in order to be able to comment on delamination. For this reason, it was impossible to control the production process in a timely manner. 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 adhering to certain threshold values, SCHOTT is now able to control the risk of delamination for the first time ever.