Pre-Sterilized & Bulk Syringe Systems

Alba^® EZ-fill^®: breakthrough solution for biologics. De-risking the development of sensitive drugs.

Alba^® EZ-fill^® syringes represent the best-in-class solution for biologics and ophthalmic applications addressing the key requirements of protein-based drugs, and minimizing adsorption, aggregation and inorganic extractable interaction.

All Alba^® EZ-fill^® products have an internal coating, based on standard silicone oil, which is cross-linked to form a chemical bond with the glass surface. It ensures that particle levels - caused by silicone migration during container storage - are significantly lower than ones using standard siliconization technologies. Moreover, the internal treatment offers superior gliding performance, reducing the risk of functional issues when combined with auto-injectors.

Due to the excellent properties of the layer, Alba^® platform mitigates packaging-related risks and enhances drug-interaction stability. Learn more about Alba® EZ-fill® syringes.

Benefits

• Particle reduction
  • Minimized subvisible particles versus conventional sprayed-on siliconized containers to alleviate potential drug-silicone interaction.
• Optimized break-loose and glide performance
  • Silicone lubricant layer integrity, optimized to withstand challenging formulations and aggressive conditions, helps conserve gliding performances throughout the drug shelf-life.
• Reduction risk of stalling and injection time variation
  • The low silicone-drug interaction helps to maintain the injection time and dose delivery with an auto-injector.
• Inorganic extractable mitigation
  • A barrier between the drug and the glass reduces the amount of inorganic extractables.
• Time stability
  • Alba^® inner coating does not undergo critical variations after contact with the placebo solution over a period of 6 months (tested @40°C/75%RH).
• Available in EZ-fill^® for seamless processing in fill & finish combo lines

Preferred market choice

• Protein-based therapeutics
• Ophthalmic applications

Nexa^®: Optimized for high-value sensitive injectables

Extremely safe, compatible, and extremely resistant, Nexa ® syringe is the preferred solution for high-value sensitive injectables drug products.

Nexa^® syringes have been specifically designed to meet the dimensional requirements of auto-injectors and to ensure excellent mechanical resistance when compared to a standard syringe. These durable properties are derived through optimized product handling throughout the entire manufacturing process (no glass-to-glass contact and limited glass-to-metal contact). Advanced in-line inspection technologies carefully check products before release, minimizing the risk of in-line breakages during filling operations and reducing the number of filled rejects.

Drug stability is ensured by an ultra-low tungsten level and an optimized silicone-oil distribution along the barrel provides enhanced gliding performance, a key aspect when integrating a syringe into a drug delivery device.

Benefits

• Ultra-low tungsten
• Optimized break-loose and glide performance
• Easily integrates with drug delivery systems

Preferred market choice

• Biologics

Fina^®: A customizable solution for your injectables

Fina^® provides a flexible platform for designing a customized prefilled syringe solution. The line boasts a wide range of container sizes and matching components.

Fina^® syringes are manufactured on fully automated production lines featuring 100% inline camera controls, inspecting all critical phases. As a result of using validated manufacturing processes, Fina^® syringes have excellent mechanical performance and cosmetic appearance - fulfilling the most stringent AQL standards.

Benefits

• Compliant with PH.Eur., USP and JP for applicable parts
• Our Regulatory Affairs team can support customer drug applications and provide authorization of DMF submissions to US FDA and Health Canada

Preferred Market Choice

• Heparin
• Vaccines
• Water For Injection

Add-on components

As a system supplier, Stevanato Group works hand in hand with rubber manufacturers to supply best-in-class components for each intended use. The plunger rod and backstop (extended finger flange) are designed for maximum compatibility with industry rubber components and safety devices.

A full range of colors and materials are available for product differentiation, dose differentiation or improved machinability.

Add-on Specifications

Plunger Rods

• 0,5 mL – 5 mL
• PS / PP

Backstops
(Extended Finger Flange)

• 0,5 mL – 3 mL
• PP

Plungers

• Best-in-class rubber components for all syringe formats
• Coated / Non-coated
• RfS / RtU