Safe’n’Sound® 5.5ml

Ensuring a safer injection process, while improving patient experience

Safe’n’Sound^® is a highly customizable platform of add-on passive safety devices for prefilled syringes. It helps in preventing needlestick injuries, providing user-friendly protection for healthcare professionals or patients.
Ergonomically designed, Safe’n’Sound® is intended for naïve users including patients with dexterity issues, experienced users, and healthcare professionals alike. It features a large thumb-pad for ease of use, and it provides a clear tip visibility for easy drug inspection. Its rounded shape allows an increased labeling surface.
The safety system is robust against shocks and vibrations and compatible with all scales of manual to fully automated assembly line.

Large-volume safety system designed for next-generation biologics

Safe’n’Sound^® 5.5 mL builds on Nemera’s proven passive safety platform to address the growing demand for large-volume (>2.25 mL) self-injection solutions. Driven by the transition from IV to SC delivery, the development of high-concentration biologics and the move toward less frequent dosing, pharmaceutical companies increasingly require devices capable of supporting larger drug payloads.
Developed in parallel with Schott Pharma’s syriQ BioPure^® 5.5 mL pre-filled syringe, it offers the first fully compatible large-volume syringe and safety device platform. This integrated approach reduces development risk, streamlines combination product development and accelerates the path to market for large-volume subcutaneous therapies.

Safe injection: Automatic needle protection
Comfortable handling: User-friendly design
Smooth injection: Low activation force
Reliable performance: Proven robustness
Optimized drug delivery: Low residual volume
Confident dose delivery: Automatic needle retraction
Facilitated drug inspection: Clear and visible tip
Increased labelling surface: Round shape

Enhance the patient injection experience, enabling safe and intuitive self-injection, including for users with hand weakness and dexterity limitations
Support large-volume delivery of high-viscosity biologics
Accelerate the path to market through integration of the syriQ BioPure^® 5.5 mL prefilled syringe and Safe’n’Sound^®
De-risk combination product development with a proven and fully compatible platform
Demonstrate proven usability through a human factors study conducted in the United States with 30 participants (July 2026), achieving 100% successful injections and a mean injection time under 30 seconds

Our Parenteral featured services

Comprehensive tests range to ensure compliant and reliable drugdevice combination, leveraging know-how on standard deliverables including robustness study, device performances, pre-conditioning.

Diversified activities to evaluate the compatibility between device platform and specific selected primary drug containers, to ensure combination product performances and regulatory dossier filing.

Complete set of tests and evaluation to prove the biocompatibility of specific drug/device development process for regulatory dossier filing.