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09.06.2015, Rimini / Italy

55° SIMPOSIO AFI: SCHOTT to Support Italian Pharma Industry with Next Generation Packaging

SCHOTT at the industry forum “55° SIMPOSIO AFI”
For the first time SCHOTT will be presenting its portfolio and innovations in pharmaceutical packaging at the industry forum “55° SIMPOSIO AFI” (Rimini, June 10-12, Boot 99). Focus will be on SCHOTT’s ingenious solution against delamination – SCHOTT Vials Delamination Controlled. These new vials bring the advantages of reduced delamination propensity and decreased risk of product recalls to the pharma industry. Furthermore, the company’s broad portfolio of glass and polymer syringes will be on display.

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. Just recently, the company has expanded its portfolio of SCHOTT Vials DC to include ISO sizes 6R, 8R and 10R in addition to the 2R and 4R vials already available.

SCHOTT is also 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,” says Dr Bernhard Hladik, Product Manager at SCHOTT Pharmaceutical Systems. ”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.

Complete Syringe Portfolio
To offer pharmaceutical companies a broad range of solutions, SCHOTT has developed a complete portfolio of both glass and polymer syringes. In the field of glass syringes, the offerings range from 0.5 to 3 Milliliter (ml) products, suitable for a broad variety of applications like heparin, vaccines, biotech, and special applications. All glass syringes are available with luer lock, luer cone or with staked needle. SCHOTT has been manufacturing glass and polymer syringes in Europe for more than 14 years. The production facility in St. Gallen, Switzerland, has developed into a center of excellence and is supported by an R&D team based at the site.

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