Oncology drug products are highly sensitive and complex molecules that are prone to drug-container interactions. Nipro PharmaPackaging offers high-quality primary packaging solutions that meet the challenging requirements of these demanding medicines. Collaborate with our dedicated, cross-functional team of experts to develop the exact packaging solution that your drug product requires, or choose from a selected oncology range.
D2F™ Pre-fillable Glass Syringes for Sensitive Oncology Medicines
Optimized Drug-Container Compatibility
- Low silicone amount | Silicone oil-free1
[lower | no risk of interactions]
- Low tungsten residual
[minimized risk of interactions]
- Minimized particle levels2
[reduced risk of interactions]
Contributes to Stable Fill-Finish Operations
- Strong mechanical durability3
[minimized risk of breakage]
- Very high cosmetic quality
[lower risk of rejection during final inspection]
- Strong container closure integrity (CCI)
[reduced risk of leakage]
- High dimensional quality
[reliable filling and plunger placement]
-
Unique identifier (UID)
[tracking of single container by radio-frequency identification "RFID" or print]
Designed to be Part of a Combination Product
- High dimensional quality with very narrow acceptable quality levels (AQLs)
[for a precise fit into the device]
- Strong mechanical durability
[reduced risk of breakage]
- Compatibility with auto-injection devices
[reliable performance]
- Homogenous siliconization4
[low break-loose force and smooth gliding force]
- Syringe size up to 3 ml
Suitable for Storage at Low Temperatures
- Functionality5 ensured down to -40°C
[secure and reliable performance] - Container closure integrity maintained5
Footnotes
-
Silicone-influenced parameters were carefully tested (break-loose force, gliding force, particle level, container closure integrity)
-
Use of light obscuration test for very precise results, laser-based cutting technology, D2F™ process takes place in ISO 7 cleanroom under laminar air flow, syringes are washed, tub & nest are cleaned with ionized air before use, careful cosmetic inspections
-
Laser-based cutting, precise forming process
-
Amount and distribution controlled 100%, in-line
-
Parameters tested: Break-loose and gliding force, particle burden, leakage test, flange breakage, cone breakage, needle & soft needle shield pull-off force, LInC™ unscrew force, plunger position, total length
Recommended Syringe Range for Sensitive Oncology Products
| RNS1 (for manual) |
RNS (for auto-injectors) |
|
|---|---|---|
| Quality level | ENHANCE | |
| Syringe size (ml) | 1 long | 2.25 | |
| Rubber material - RNS | 4800 GS | FM30 | 7025/65 | |
| Stopper material supplier | West | Datwyler | GORE2 | |
| Silicone amount (mg) | 0.35 to 0.55 | Silicone oil-free2 | |
| Flange type | Cut flange | Round | Small round |
| Staked needle | 27G ½“ or 29G ½“ with thin- or extra-thin wall | |
Footnotes
- Rigid Needle Shield
- 1 ml long only
Related products
Glass Vials for Sensitive Oncology Drug Products
Lower risk of Drug-Container Interactions
-
VIALEX™ - Significantly lower risk of interactions between drug molecules and formulations with the inner glass surface1
[more stable drug storage]
-
VIALEX™ - Reduced risk of glass delamination1
[potential longer shelf-life]
-
Silicone coating on inner surface of vial (optional)
-
Amber glass for light-sensitive medicines
-
Glass tubing in ENHANCE quality
[Type I, Borosilicate, 51 expansion]
Enhanced Lyophilization Process
VIALEX™ - Optimized lyophilization process2
[contributes to less fogging]
Design for Viscous and Large Volumes
- Vial size up to 100 ml
- Optional silicone coating on inner surface of vial
[contributes to a higher restitution rate]3
Contributes to Stable Fill-finish Processes
- High dimensional quality expressed in very narrow AQLs
[supports efficient filling process]
- Strong mechanical durability
[reduced risk of vial breakage during filling operations]
- Very high cosmetic quality
[less risk of rejects during final inspection]
- Optional UID for single container tracking4
[track and trace of singles containers]
Footnotes
-
Results of long-term study - 24 weeks at 40°C: Phosphate, High purity water, Citrate, NaCl with terminal sterilization
-
Results of Simtra Biopharma Solutions study: Introduction to Vial Fogging and Mitigation Strategies Kevin Bond, Research Associate II – Inc. Live Webinar Transcription, 2022
-
Test results available upon request
-
Print of 2D data matrix code on vial barrel
VIALEX™ - Exceptional Inner Surface Durability
The inner glass surface of the vial undergoes Nipro's proprietary thermal process, known as VIALEX™ treatment, which involves no additional materials or alteration in glass chemistry and is subject to 100% in-line inspection. This treatment mitigates the effects of the converting process in two ways: by reducing sodium concentrations and by improving the inner glass surface.
VIALEX™-treated vials offer unparalleled benefits for challenging drug formulations, featuring exceptional inner surface durability. The enhanced durability leads to lower levels of extractables and leachables (E&L), minimizing the risk of pH shifts and delamination events. Additionally, VIALEX™ technology has a positive effect on the lyophilization process, resulting in less fogging. These benefits enhance the storage stability of drug products and contribute to a longer shelf-life.
Recommended Vials for Sensitive Oncology Products
| Specifications | |
|---|---|
| Quality level | ENHANCE |
| Vial size (ml) | 2R to 50R |
| Glass color | Clear | Amber |
| Inner surface treatment | VIALEX™ | Siliconization |
| Silk screening |
Medical Devices for Easier and Safer Reconstitution
As a vertically integrated company Nipro offers you a selective range of medical devices. D2Mix™ reconstitution devices enable safer and easier reconstitution of a drug product with a diluent in just a few steps. Consult the full range of devices to discover which device best fits your requirements.
Related products
High-quality Primary Packaging and Medical Device Solutions
for Sensitive Oncology Drug Products!
Need help?
Get in touch
For information regarding Nipro products, services, and resource material:
| Give us a call +32 15 263 500 |
E-mail us pharmapackaging@nipro-group.com |
| Submit a detailed inquiry: Contact per expertise |
View our manufacturing locations: Our global network |