Nipro launches Silicone Oil-Free D2F™ Pre-fillable Glass Syringe System
Ideal solution for drug product sensitive to silicone-oil
At present, the inner glass surface of the large majority of ready-to-use pre-fillable glass syringes delivered to the pharmaceutical industry are siliconized. Silicone oil acts as a lubricant to enable the movement of the plunger in the syringe barrel ensuring its functionality.
However, silicone oil can interact with highly sensitive molecules in biotech products. For this reason, it has been recognized as one of the potential causes for aggregation and particle formation in therapeutic protein formulations.
Today, more than 80% of injection drugs in the drug pipeline are biotech products and the demand for silicone oil-free injection systems is growing.
Nipro launches the new D2F™ Pre-fillable Glass Syringe System – Silicone Oil-Free. This new drug delivery system is a solution for drug products highly sensitive to silicone oil.
The key quality attributes of the D2F™ Pre-fillable Glass Syringe System – Silicone Oil-Free have been thoroughly tested and the results confirm:
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Smooth Plunger Movement Performance
Consistent break loose and gliding forces due to plunger characteristics and hydrophilic glass surface with high surface free energy, good wettability, and good adhesiveness - Very Low Particle Levels
Amount of visible and subvisible particles significantly below the limit criteria in EP 2.9.20 and EP 2.9.19 - Container Closure Integrity
- Excellent Drug-container Compatibility
- Smooth Integration into Auto-injection Devices
- Optimized Processability for Minimal Drug Loss
- Extended Data Package for Fast Acceptance of Goods
