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V6 Safer Syringe

V6 Safer Syringe

V6 Safer Syringe

Product catalog summary
Manufacturing & Engineering
Our experienced team specializes in innovative medical devices and pharmaceutical packaging solutions. Key areas include manufacturing process development, process characterization and validation, predictive engineering, lean manufacturing with Six Sigma, and automation development. We handle polymers, additives, and various plastic material processes such as compounding, extrusion, overmolding, injection molding, and assembly. Our supply chain management ensures efficiency.

R&D, Regulatory & IP
Our in-house R&D team rapidly transforms innovative concepts from design to patent and production. Services include finite element analysis, feasibility studies, prototyping, design verification and validation, and certification from pilot to full-scale manufacturing.

Facility
Our facility is dedicated to drug delivery devices for regulated medical use, featuring a cleanroom area of 1800 sqm, a molding area of 2100 sqm, a temperature-controlled warehouse of 1200 sqm, and an office and technical area of 1600 sqm. There is ample space for future expansion.

SafeR® Syringe
The SafeR® Syringe is a passive safety syringe with a retractable needle designed to enhance healthcare safety. It features a one-touch coaxial needle retraction system that activates automatically after injection. This product complies with the USA Needlestick Prevention Act 2000 and the European directive 2010/32/UE, addressing the WHO's concern about unsafe injections leading to millions of infections annually.

Product Features
Available in various formats (1ml, 2ml, 3ml, 5ml syringes and 20G to 27G needles), the SafeR® Syringe meets regulatory requirements with CE marking. It includes safety-engineered mechanisms such as Auto Disable (AD), Re-Use Prevention (RUP), and Sharp Injury Protection (SIP). The design ensures minimal force is needed to activate the safety feature, minimal dead space, and waste material. It is user-friendly, requiring no specific training.

Materials
The syringe is made from materials like PP, COC, and COP, ensuring durability and safety.
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Catalog excerpts

V6 Safer Syringe-1

We make drug delivery safer! MANUFACTURING & ENGINEERING Our highly skilled team with 20+ years of experience delivers innovative medical devices and pharma packaging solutions. Our in-house R&D takes innovative concepts from design to patent and production in record time. Our state-of-the-art facility focuses on drug delivery devices for highly regulated medical use. Finite Element Analysis. Manufacturing process development. Feasibility studies and prototyping. Process characterization and validation. Multi-technology platform. Predictive engineering. Design verification and validation. Office and technical area: 1600 sqm. Lean manufacturing - Six Sigma. Polymers, additives. Automation development. Compounding, extrusion, overmolding, injection molding, and assembly of plastic materials. We believe everyone deserves safer healthcare practices Ample greenfield for expansion. Certification, from pilot to fullscale manufacturing. THE PASSIVE SAFETY SYRINGE WITH RETRACTABLE NEEDLE Supply Chain. One-handed activation Roncadelle Operations s.r.l. Via Renolda 10 25030 – Castel Mella (BS) – Italy T. +39 030 6724310 [email protected]

 Open the catalog to page 1
V6 Safer Syringe-2

WHO: unsafe injections lead to an estimated 23 milion infections a year USA Needlestick Prevention Act 2000 and European directive 2010/32/UE require healthcare facilities to prevent needlestick injuries providing medical devices with safety and protection mechanism. Our passive safety syringe solution Our safety engineered solution to improve the healthcare system SafeR® Retractable Syringes work with SafeR® Needles. Just one click SafeR® Retractable Syringe features a one-touch coaxial needle retraction system that automatically activates upon completion of the injection. SAFE SUSTAINABLE SMART...

 Open the catalog to page 2

All Roncadelle Operations s.r.l. catalogs and technical brochures

  1. FDA 510K

    11  Pages

  2. White Paper

    32  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.