syriQ BioPure®

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Product description
Technical details

Glass syringes for sensitive drugs

Sensitive drugs such as biologics may interact with the container system. These interactions are unpredictable and can lead to aggregation or deterioration, which can compromise the drug’s shelf life, treatment efficiency, and total cost of ownership.

SCHOTT syriQ BioPure® handles these complex drugs with safety and functionality. The manufacturing process of syriQ BioPure® is designed to reduce the amount of tungsten and adhesive residues, as well as ensure a uniform silicone layer. With high dimensional accuracy, tighter tolerances and other dimensions beyond ISO requirements, device compatibility has been tested and verified with the leading autoinjector and safety device platforms.

Properties

Low levels of Extractables & Leachables.
Reduced silicone levels.
The syriQ BioPure® platform is available in 1 ml long and 2.25 ml formats.
Ultra-low tungsten residuals (ICP-MS certificate available).
A comprehensive documentation package, including design control and a detailed Certificate of Analysis, is available.

Chemical Resistance

SCHOTT syriQ BioPure® syringes are manufactured with tighter specifications for improved performance, while additional quality controls are implemented to mitigate the risk of drug-container interaction. The syringes display the following attributes:

• Ultra-low tungsten residuals (ICP-MS certificate available).
• Reduced silicone levels.
• Low adhesive residuals.
• Low E&L from the latest high-quality elastomer formulations.

Dimensions & Cosmetics

• New manufacturing technology provides tighter specifications for glass particles, cosmetic defects and subvisible particles.
• Smaller inner diameter tolerance of the glass tube for improved plunger tightness and a reduced and uniform silicone level for consistent gliding forces.
• Improved flow of viscous drugs through extra-thin needle walls.
• Additional critical dimensional measurements implemented in alignment with industry-leading device manufacturers.

Possible Applications

Biologics and Biosimilars
SCHOTT syriQ BioPure® syringes address the administration of new and complex biologics and biosimilars, such as monoclonal antibodies and proteins.
Hospital and Home Care
Medical drug treatments demand high levels of reliability from products that combine the drug, primary packaging and injection device. The syriQ BioPure® platform is the ideal product for hospitals and the home.

Advantages

• Choice of syringe design available thanks to platform validation approach (1 ml long staked needle or 2.25 ml staked needle).
• Verified compatibility with a wide range of safety devices and autoinjectors.
• Robust injection duration due to a consistent and uniform silicone layer.
• DHF Ready (acc. to FDA 21CFR Part 820) to support the combination product requirements.
• Validated and documented manufacturing process.

Package Information

• Nest 100 or Nest 160.
• Single or double Tyvek® inlay (e-beam compatible).
• Single or header bag on demand.

SCHOTT Pharma Online Shop.

Our Online Shop provides an easy and fast access to small volume and high quality pharmaceutical packaging solutions. With standardized and pre-tested products we ensure fast delivery times. Our customer care helps you in case you need a product recommendation to safely package your drug.

Open at all times. Quality at all times.