04.20.18
SCHOTT has introduced its syriQ BioPure, pre-fillable glass syringes for biologics designed to ensure drug stability and ease administration, as well as shorten time to market. Key features include ultra-low tungsten and low adhesive residuals and accurate dimensions for optimal device compatibility. Also, more than 48 pre-validated configurations are available with top-class elastomer components.
“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).
The syringes offer an improved extractables and leachables profile and are made of highly inert FIOLAX borosilicate glass for packaging complex drug products. In addition, the syriQ BioPure syringes are available with a range of coated plunger stoppers tailored for sensitive applications. Options include various closure systems, such as Aptar 4800, Aptar 4900, West 7025 and West 7028.
The new glass syringes work with leading safety and autoinjector devices to meet market demand for products that can be administered at home. Integration into these devices is achieved with 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 forming technology and online inspection systems.
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.
The syringes are documented according to the latest design controlled guidelines (FDA 21CFR Part 820) to support the combination product requirements to help shorten time to market with all required documentation readily available.
“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).
The new glass syringes work with leading safety and autoinjector devices to meet market demand for products that can be administered at home. Integration into these devices is achieved with 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 forming technology and online inspection systems.
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.
The syringes are documented according to the latest design controlled guidelines (FDA 21CFR Part 820) to support the combination product requirements to help shorten time to market with all required documentation readily available.
