SCHOTT will be presenting SCHOTT Vials DC - a pharmaceutical vial that, for the first time ever, allows for the risk of delamination to be determined based on threshold values.
SCHOTT monitors these values over the course of the manufacturing process and is thus able to minimize the risk of delamination.
The company succeeded in optimizing its manufacturing process to ensure that SCHOTT Vials DC have a more homogeneous surface, hence offering high chemical stability.
Furthermore, SCHOTT is the first manufacturer to develop a patented test method that even allows for this lower tendency to delamination to be documented - known as SCHOTT Delamination Quicktest. SCHOTT Vials DC will be available as 2R to 10R ISO vials starting at the beginning of 2014.
The problem of delamination, in other words the peeling off of flakes from the inner glass surface of a pharmaceutical vial as a result of interaction with the formulation and / or medication, has become increasingly important to the pharmaceutical industry in recent years.
Numerous recalls clearly confirm this, and the US drug authority in turn is explicitly requiring that pharmaceutical companies manage their risks more closely.
SCHOTT Vials DC thus represents an interesting solution for pharmaceutical companies interested in lowering the risk of delamination by selecting an improved packaging product. These vials are an interesting alternative not only for new products, but also for products that are already well established in the marketplace.
A more homogeneous surface thanks to a better production process
Dr. Bernhard Hladik, Head of Product Management, says that the mechanism behind delamination has been researched quite thoroughly and is well understood. “When the bottom of the vial is formed, volatile components like boron and sodium evaporate. They then go on to form inhomogeneous spots on the glass surface near the bottom of the vial that show a higher tendency to delaminate. With our new SCHOTT Vials DC, we have developed the production process even further to ensure that the glass surface is more homogeneous and thus less susceptible to delamination.”
To confirm this effect, SCHOTT conducted storage studies with systems that showed a high tendency to experience delamination while using standard Type I vials. The result: SCHOTT Vials DC remained stable even after six weeks of storage involving a 15% potassium chloride solution and a 10% sodium thiosulfate solution at a temperature of 60°C, while conventionally manufactured vials showed clear initial signs of delamination.
How the SCHOTT Delamination Quicktest works
SCHOTT is currently 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 Quicktest and had it patented. “In the past, the vials had to be examined 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,” Hladik adds.
He describes the way in which the SCHOTT Delamination Quicktest works as follows: “A certain number of vials are removed from every batch. The random samples are then subjected to stress for four hours inside an autoclave in order to tease out 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.