SASY™-G1 transforms a staked needle prefilled syringe into a passive safety syringe. It maintains the familiar usability of standard prefilled syringes and safety syringes, with no changes to injection technique. The intuitive, innovative design ensures full dose delivery and activation of the safety mechanism. At the end of injection, the PFS retracts into the safety device. The SASY™-G1 is a single-use disposable device that is connected to the syringe as an external add-on.
The syringe is pre-assembled in the SASY™ G1, with the PFS automatically retracted into the safety device.
Assured full-dose delivery Special patented mechanism ensures complete dose delivery
Automatic passive safety activation Automatic retraction mechanism provides passive protection against needlestick injuries
Usability Maintains standard injection practice with no change to technique
Ergonomic and comfortable handling Designed for smooth, controlled handling and injection
Large drug inspection window Clear visibility of drug, injection progress, and all printed labeling
Durable, transport-safe construction Remains stable and secure throughout handling and transportation, preventing inadvertent pre-activation
Large labeling area Ample space for clear product identification and branding
Regulatory-supportive design Unchanged primary container and drug contact path simplify regulatory approval
Same usability Same handling as standard prefilled syringes and commonly used safety syringes
Simplified supply-chain integration External add-on to existing prefilled syringe with no plunger rod changes, preserving current manufacturing and commercial configurations
The prefilled syringe is pre-assembled in the SASY™-G1 add-on passive safety device, ready for use.
The needle is automatically shielded and locked.
In known passive safety syringes, users may feel noticeable resistance (a mechanical stop) when pressing the plunger. This stems from the inherent mechanism, which can interrupt the usability flow and increase the risk of early stopping, leading to underdosing and an exposed needle (the passive safety mechanism not activating as intended). For those devices, users need to be guided and pre-trained that, once they feel this mechanical stop, they should apply additional force to the plunger to overcome this resistance.
In fact, testing of common commercial safety syringes has shown that user usability errors related to this resistance could result in underdosing of up to 33% (for 0.4 mL fills) and 13% (for 1 mL fills) of the nominal fill volume (95% confidence interval). *
SASY™-G1’s innovative design, based on a patented mechanism, enables highly intuitive use without resistance or additional force required during injection. It maintains a smooth, continuous injection motion, ensuring complete dose delivery and activation of the passive safety mechanism, while maintaining the same usability as the original PFS and/or common safety syringes.
SASY™-G1 can be easily assembled with 1 mL staked-needle glass prefilled syringes at the final assembly stage. The device is assembled externally without modifying the syringe or contacting the drug product and is supplied as two sub-assemblies for streamlined assembly around the prefilled syringe.
SASY™-G1 can be easily assembled with 1 mL staked-needle glass prefilled syringes at the final assembly stage. The device is assembled externally without modifying the syringe or contacting the drug product and is supplied as two sub-assemblies for streamlined assembly around the prefilled syringe.
| Description | Details |
| Primary Container | 1 mL Glass Staked Needle Prefilled Syringe (PFS) |
| Viscosity | Compatible with a wide range of formulation viscosities |
| Safety Mechanism | Passive. syringe automatically retracts into the device |
| Ergonomics | Large thumb pad and built-in finger flange for comfortable and secure handling |
| Material | High-quality medical-grade plastics |
| Durability | Robust and mechanically stable design withstands transport shocks and vibration |
| Customization Options | Syringe – volume and material; thumb cap and finger flange – shape and textures; branding – logo, colors, labeling |
Tailored to your therapy, formulation, and device requirements
Our team will customize your product to ensure complete compatibility, functionality, and usability.
| Category | Customizable Options |
| Primary container | 2.25 mL is under development; additional volumes available on request; customizable for glass or polymer syringes |
| Plunger rod | Compatible with the original PFS plunger or available as optional customizable add-on |
| Thumb press | Customizable shape, size, color, and texture |
| Finger flange | Customizable shape, size, color, texture |
| Branding | Custom color-coding, logo placement, and partner-specific branding options |
| Viscosity | Customizable to support different formulation viscosities and delivery profiles |
A customized version of SAN®-Light, for Lanreotide, was launched in the U.S. (Combination Product) by an Indian pharmaceutical company in 2024. For more information, click the Success Story.
*This product is under development
DALIMED has been developing drug delivery devices from concept to commercialization since 2003, serving pharmaceutical and medical device companies.
Our injectable solutions are designed to improve patient compliance with biologic, biosimilar, and generic therapies, offering greater ease, comfort, and enabling simple self-administration. With expertise across the full product lifecycle, we provide both market-ready devices and customizable solutions tailored to specific needs-covering everything from design and development to verification, validation, and compliance with all relevant standards and regulations.
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