Product/Service

Pre-Sterilized & Bulk Syringe Systems

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Stevanato Group through its historical brand Ompi provides a wide range of washed, siliconized and pre-sterilized SG EZ-fill® syringes systems. Available in a range of sizes from 0,5 ml to 5 mL with staked needle, Luer cone or Luer lock adapter. Bulk syringe systems are available with or without staked needle and provided in trays.

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

SG 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 SG 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, SG Alba® platform mitigates packaging-related risks and enhances drug-interaction stability.

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
    • SG 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 SG EZ-fill® for seamless processing in fill & finish combo lines

Preferred market choice

  • Protein-based therapeutics
  • Ophthalmic applications

SG 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.

SG 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

SG Fina®: A customizable solution for your injectables

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

SG 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, SG 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