Tiskové zprávy

09.10.2018, Madrid, Spain

The Next Generation Vials from SCHOTT: Perfection made for people

SCHOTT is presenting a new concept for pharmaceutical vials at this year’s CPhI Worldwide trade show. The 'Next Gen Vials' combine a number of features leading to unmatched drug stability even for so-called low-fill applications and efficient and cost-competitive fill & finish. The superior chemical resistance and extractables and leachables (E&L) profile make the vials highly suitable for sensitive biotech drugs, high potent drugs or vaccines. The vials are made of an improved Type I FIOLAX® borosilicate glass and include the company's validated delamination controlled production process, both ensuring a particularly improved resistance of the inner surface. Pharma companies can replace conventional tubular type-I glass vials for already marketed drugs with the next generation of vials without costly re-registration. The complete product offering will be based on a modular approach depending on the customer’s needs. The new vials reflecting the first features for a perfect fit for use are now ready for order from the company's US and German facilities. Pharma manufacturers can learn more about SCHOTT's latest innovation at CPhI booth 4B10 (Oct. 9-11, 2018, Madrid, Spain).
Intelligent combination
"The next generation of vial is the result of longstanding expertise and co-innovation with our customers", SCHOTT Executive Vice Presidents Andreas Reisse and Patrick Markschläger say in unison. The two head the company's pharmaceutical systems and tubing businesses. "New therapies require the packaging to attribute greater attention to drug stability and minimize drug/container interaction during shelf life – yet pharma manufacturers want to avoid the hassle of lengthy registration processes. At the same time, performance on the filling line needs to ensure higher and higher yields," Reisse adds.

SCHOTT has taken action on all of these aspects in recent years, including an improved converting process to control the risk of delamination and the introduction of an improved FIOLAX® borosilicate glass, named by its hydrolytic custom specification FIOLAX® CHR (controlled hydrolytic resistance). With the Next Gen Vial concept, these and upcoming benefits and innovations will be combined in a modular product offer.

Vials with improved Hydrolytic Resistance
The chemically homogeneous FIOLAX® CHR tubing lays the foundation for a unique vial that meets 21st century market demands. This borosilicate glass comes with a highly reduced and certified level of alkalinity release of the inner surface, enabling a superior extractables & leachables profile with the right converting process. Besides the hydrolytic resistance test according to EP 3.2.1 and USP <660>, the company’s patented SCHOTT Quicktest® is used as release criteria to ensure this superior leaching profile and the delamination controlled process.
The unique combination of superior glass and converting process leads to a high chemical stability and improved resistance of the inner surface of the vial, especially in the bottom area.

Perfect fit for low-fill applications
This superior chemical profile is especially beneficial for biologics, high potent drugs, vaccines and so-called low-fill applications. The latter refers to the vial being filled with a significantly smaller amount of the drug than the nominal volume of the container. Consequently, the ratio of the wetted surface to the volume is increased, which leads to a proportionally increased concentration of leached elements. This is particularly critical for sensitive formulations. Thanks to their high chemical resistance SCHOTT’s next generation vials show a low concentration of leached “glass” elements even for low fill volumes – a major advantage over vials made of aluminosilicate glass.

Outlook – towards efficient processing by perfect geometry
To further achieve better yields on pharma customers’ filling lines, SCHOTT is working on additional parameters, which will be introduced into the modular Next Gen Vial concept in the upcoming month. These include production optimization, inspection and packaging for flawless glass quality and increased glass strength. Smooth filling line operations is further enhanced through a low-friction outer surface. Interested customers are highly encouraged to reach out to the SCHOTT team.


About SCHOTT
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, pharma, electronics, optics, life sciences, 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 33 countries. With its workforce of approximately 15,000 employees, sales of 2.05 billion euros were generated in fiscal year 2016/2017. 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.
Next Generation Vials
Press contact
SCHOTT AG
Joana Kornblum
PR & Communication Assistant Manager
Pharma | Medical | Diagnostics
Hattenbergstraße 10
55122 Mainz
Telefon: +49 6131/66-4073
Veletrhy a události
23.
October
Trade fair Glasstec, Düsseldorf, Deutschland, 23.10 - 26.10.2018
05.
November
Trade fair CIIE - China International Import Expo, Shanghai, 中国, 05.11 - 10.11.2018
06.
November
Trade fair Vision, Stuttgart, Deutschland, 06.11 - 08.11.2018
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