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04.02.2015, Mainz

Delamination Under Control

New sizes for SCHOTT Vials DC available
Mainz, February 4, 2015 – In line with previous announcements, SCHOTT has extended its SCHOTT Vials DC (Delamination Controlled) product range. These new vials bring the advantages of reduced delamination propensity and decreased risk of product recalls to the pharma industry. Specifically, 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. The new sizes will be available from February 2015 on.

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.

Dr. Bernhard Hladik of SCHOTT Pharmaceutical Systems explained that, "Minimizing the risk of delamination is a top priority for many pharmaceutical manufacturers due to the very costly drug recalls it can cause. The concept of SCHOTT Vials DC has therefore generated great interest within the industry. In order to offer maximum flexibility to our customers we are continuously extending our range of vial sizes and are also able to work on customized solutions.”

How the SCHOTT Delamination Quicktest works
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,” 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 is a leading international technology group in the areas of specialty glass and glass-ceramics. The company has more than 130 years of outstanding development, materials and technology expertise and offers a broad portfolio of high-quality products and intelligent solutions. SCHOTT is an innovative enabler for many industries, including the home appliance, pharmaceutical, electronics, optics, automotive and aviation industries. SCHOTT strives to play an important part of everyone’s life and is committed to innovation and sustainable success. The group maintains a global presence with production sites and sales offices in 35 countries. With its workforce of approximately 15,400 employees, sales of 1.87 billion euros were generated in fiscal year 2013/2014. The parent company, SCHOTT AG, has its headquarters in Mainz (Germany) and is solely owned by the Carl Zeiss Foundation. As a foundation company, SCHOTT assumes special responsibility for its employees, society and the environment.
Press contact
Christina Rettig
Public Relations Manager
Hattenbergstraße 10
55122 Mainz
Phone: +49 6131/66-4094
Further information
Salvatore Ruggiero
Vice President Marketing and Communication
Hattenbergstraße 10
55122 Mainz
Phone: +49 6131/66-4140