SCHOTT, an international technology group, has introduced SCHOTT Vials DC, which further minimize the risk of glass delamination. The company optimized its manufacturing process to ensure that SCHOTT Vials DC have a more homogeneous surface and high chemical stability, and tests the vials using the SCHOTT Delamination Quicktest, a first-of-its-kind, patented test method that documents a container’s tendency toward delamination.
For the first time ever, SCHOTT has developed threshold values that it can monitor over the course of the manufacturing process to control and minimize the risk of delamination.
SCHOTT Vials DC will be available as 2R to 10R ISO vials starting at the beginning of 2014, and displayed at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in San Antonio, Texas.
Concern over the problem of delamination—the peeling off of flakes from the inner glass surface of a pharmaceutical vial as a result of interaction with the formula—has risen in recent years following numerous vial recalls. In turn, the US Food and Drug Administration is explicitly requiring that pharmaceutical companies manage their risks more closely.
SCHOTT Vials DC thus represent an improved packaging product for pharmaceutical companies interested in lowering the risk of delamination. These vials are a viable 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
The causes of delamination have been researched quite thoroughly and are well understood. “When the bottom of the vial is formed, volatile components like boron and sodium evaporate,” said Gerry Wilkins, director of sales for SCHOTT North America. “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 advanced the production process 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 toward delamination while using standard Type I vials. The results showed that SCHOTT Vials DC remained stable even after six weeks of storage involving a 15 per cent potassium chloride solution and a 10 per cent sodium thiosulfate solution at a temperature of 60 degrees Celsius, while conventionally manufactured vials showed clear initial signs of delamination.
SCHOTT is an international technology group with more than 125 years of experience in the areas of specialty glasses and materials and advanced technologies. SCHOTT ranks number one in the world with many of its products. Its core markets are the household appliance, pharmaceuticals, electronics, optics, transportation and architecture industries.