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
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