At Interphex 2015, SCHOTT will introduce a new polymer prefillable syringe designed to improve the safety and stability of sensitive drugs (SD). As pharma companies are looking for safe and reliable packaging solutions, the new product named SCHOTT TopPac® SD offers new features for a reduced E&L (extractables and leachables) profile. For the first time, these new features were combined with the proven benefits of the SCHOTT TopPac® polymer syringe system.
Through specific component selection and an optimized processing method, SCHOTT TopPac® SD offers a significantly reduced level of impurities, decreasing the chance of drug/container interaction. The syringe features an inert COC barrel (cyclic olefin copolymer) that releases no ions or heavy metals, and reduces the chances of a chemical interaction with sensitive drugs. Additionally, the PFS (prefilled syringe) was developed with pure elastomer components in order to reduce the E&L profile. Cross-linked silicone for barrel lubrication reduces the amount of subvisible particles with optimal functionality. Finally, the new syringes are sterilized with an ETO (Ethylene Oxide) sterilization method, rather than irradiation, to further reduce the E&L profile.
While the new product features a number of components that were specially designed to house sensitive drugs, the PFS also retains the traditional advantages of the TopPac product line, including glass-like transparency, an integrated Luer Lock system, standardized tub-and-nest offerings, and compatibility with needleless IV connectors.
“As more sensitive drugs enter the market, the need for high-quality, reliable packaging becomes increasingly important,” said Anil-Kumar Busimi, Head of Global Product Management Syringes Business. “SCHOTT TopPac® SD provides pharmaceutical manufacturers a trusted solution for their sensitive drugs and supports patient safety."
SCHOTT TopPac® is registered trademarks of SCHOTT AG and SCHOTT North America, Inc.
SCHOTT (schott.com) 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 $2.55 billion were generated in fiscal year 2013/2014.