SCHOTT solutions no. 2/2013 > Pharmaceutical Packaging
SCHOTT® Vials DC (DC = delamination controlled) offer a future-oriented packaging solution for pharmaceutical companies interested in reducing the risk of delamination by providing an improved packaging product. Photo: SCHOTT
SCHOTT is the first manufacturer to offer pharmaceutical vials that lower the risk of delamination so that it remains within threshold values. This was made possible by an optimized manufacturing technique and a patented Quicktest.
The problem of delamination, which is the peeling of inorganic flakes from the inner glass surface of a pharmaceutical vial as a result of interaction with its contents, remains a top priority issue for the pharmaceutical industry. This phenomenon has already caused numerous recalls that can each cost several million dollars. The US drug authority is thus explicitly requiring that pharmaceutical companies manage their risks more closely. But there is good news: SCHOTT® Vials DC (DC = delamination controlled) offer pharmaceutical companies a new way to lower the risk of delamination by providing an improved packaging product. These vials are a future-oriented solution not only for new products that have yet to undergo stability tests, but also for those that are already well established in the marketplace.
A more homogeneous surface thanks to an improved production processDr. 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, such as 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 improved 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 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 thiosulfate solution at a temperature of 60° C, while conventionally manufactured vials showed clear initial signs of delamination.
When delamination occurs, inorganic flakes become dislodged from the inside surface of the glass with a pharmaceutical vial (see also micro photo to the right). Photos: SCHOTT
How the SCHOTT Delamination Quicktest worksSCHOTT 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,” Hladik adds. ”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. SCHOTT® Vials DC will be available in the ISO formats 2R to 10R (2 to 10 milliliters) starting at the beginning of 2014.
SCHOTT developed a Quicktest for use in vial manufacturing to determine the risk of delamination with the help of threshold values. First, random samples are subjected to stress in the form of steam inside an autoclave to identify the zone in which the risk of delamination is the highest. Then, the vials are filled with high purity water and sodium is extracted inside an autoclave (see photo). The sodium extracted correlates with the probability that the vials will experience delamination at a later point in time. Photo: SCHOTT/T. Hauser