SCHOTT introduces syriQ BioPure, prefillable glass syringes for the biologics market, designed to keep sensitive drugs stable for their entire 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 owing 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 US Food and Drug Administration latest guidelines.
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 includes 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 device compatibility by design, and therefore leads 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 presterile 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 at INTERPHEX in New York (booth 1212) and at CPhI North America (booth 2020).
The syringes are documented according to the latest design controlled guidelines (21 CFR 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.
