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• New prefillable syringe designed to ensure drug stability and ease administration;
• Key features include ultra low tungsten and low adhesive residuals and accurate dimensions for optimal device compatibility;
• Over 48 pre-validated configurations with top-class elastomer components.
SCHOTT introduces syriQ BioPure®, pre-fillable glass syringes for the biologics market, designed to keep sensitive drugs stable over shelf life and shorten time to market while making administration more convenient for patients. “Sensitive and complex drugs are often highly viscous, which makes them more difficult to administer. Furthermore, they are prone to interaction with the container due to their complex molecule structure,” said global product manager Dr. Nicolas Eon. Hence, syriQ BioPure® syringes are manufactured under improved processes to lower tungsten and adhesive residuals and to ensure a uniform silicone layer all validated and documented according to U.S. Food and Drug Administration latest guidelines. Samples of the staked-needle syringes are available upon customer requests (NFHU not for human use).
High-end materials for improved E&L profile
The syringes are made of highly inert FIOLAX® borosilicate glass, the gold standard for packaging complex drug products. Thanks to its strong track record, the suitability of this glass type for sensitive drugs is well researched.
In addition, the syriQ BioPure® syringes are available with a range of coated plunger stoppers tailored for sensitive applications. More than 48 combinations have been validated. Options include various closure systems, such as Aptar 4800, Aptar 4900, West 7025 and West 7028. The use of high-end materials further attributes to the superior E&L profile (Extractables & Leachables) of syriQ BioPure®.
Seamless autoinjector integration
The new glass syringes work with leading safety and autoinjector devices, meeting market demand for products that can be administered at home for patient comfort. Seamless integration into these devices is reached thanks to the syringe’s high dimensional accuracy. This include glass tubing inspected with SCHOTT’s big data perfeXion™ process, additional dimensions beyond ISO requirement and new geometrical tolerances achieved by our cutting edge forming technology and online inspection systems. This ensures the device compatibility by design, and therefore lead to superior functionality in the patient experience.
A new member of the iQ™ platform
The latest member of SCHOTT’s iQ™ platform of ready-to-use packaging is delivered pre-sterile in a standard nest and tub. The syringes can be filled on a wide variety of standard RTU (ready-to-use) filling lines and are easy to handle. SCHOTT will launch syriQ BioPure® April 17 19 at INTERPHEX in New York (booth 1212) and at CPhI North America (April 24 26, Philadelphia, booth 2020).
The syringes are documented according to the latest design controlled guidelines (acc. to FDA 21CFR Part 820) to support the combination product requirements. This leads to a short time to market for the pharmaceutical industry as all required documentation is fully available.
About SCHOTT
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, 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 $2.26 billion were generated in fiscal year 2016/2017.
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