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Stevanato Group provides a wide range of washed, siliconized and pre-sterilized EZ-fill® syringe systems, including bypass ones. 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.
Broad range of added value services – regulatory expertise in combination products as well as characterization test in ISO 17025 accredited labs (aligned with GMP) in Stevanato Group’s Technology Excellence Centers.
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.
STAKED NEEDLE
LUER
0.5 ml
1.0 ml long
1.0 ml Short
1.25 ml
1.5 ml
2.25 ml
3.0 ml
5.0 ml
5.0 ml bypass
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
Heparin
Vaccines
Water For Injection
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.
STAKED NEEDLE
LUER
1.0 ml long
1.0 ml
2.25 ml
Off the shelf
To be developed
Upcoming
* Additional formats of 1.25ml and 1.5ml are available upon request.
Ultra-low tungsten
Optimized break-loose and glide performance
Easily integrates with drug delivery systems
Biologics
GLP-1
Nexa® is also available with Integrated Tip Cap (ITC) to streamline vaccine manufacturing processes and address evolving industry needs.
Enhanced Quality Specifications guaranteeing high performance and reliability
Optimized Total Cost of Ownership - Implementation of 100% inline cosmetic controls ensures consistently superior quality, reducing the likelihood of rejected units.
Improved Flexibility and Supply Availability - Available from 1ml to 2.25ml capacity
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.
STAKED NEEDLE
LUER
0.5 ml
1.0 ml long
2.25 ml
Off the shelf
To be developed
Upcoming
All Alba® EZ-fill® products have an internal coating, based on standard silicone oil, which is cross-linked. 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.
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).
*Functionality, subvisible particles (MFI + Light Obscuration) and silicone layer thickness performance till 12 months stability . Internal study, 2023
Protein-based therapeutics
Ophthalmic applications
mRNA-based applications
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.
Plunger Rods
Backstops
(Extended Finger Flange)
Plungers
Our Special Thin-Wall needle is a 27G and 29G ½” 5B needle with an enlarged internal channel diameter to optimize the delivery of highly viscous drug formulations without the need for bigger needles, thereby satisfying auto-injector device requirements and enhancing the overall patient experience.
Dual chamber syringes represent the optimal choice for applications which require drugs to remain separated until just before administration. Dual chamber syringes are made up of two chambers separated by a plunger – the system allows the two substances to be reconstituted when required, preventing premature mixing of drug components while maintaining the ease of use of a pre-filled syringe system. Our syringe portfolio supports pharma companies to ensure the safe and efficient administration of complex drugs, with the ability to develop different formats, depending on the application.
