The global rise in chronic diseases, such as diabetes, cardiovascular conditions, hormone-related disorders, and obesity, fueled by lifestyle changes and an aging population, continues to significantly increase demand for primary pharmaceutical packaging designed to contain and protect drug products aimed at treating these conditions.
As self-administration of drug products becomes more common in the treatment of chronic diseases, their reliability and ease of use must be priority considerations. Our containers are designed for stable performance and precise compatibility with auto-injectors and pen injection systems. They are fully customizable to align with the operational expectations of our business partners and the specific characteristics of their drug products.
D2F™ Pre-Fillable Glass Syringes
Optimized Drug-Container Compatibility
- Low in silicone | Silicone oil free1
[less silicone | no risk of interactions]
- Low tungsten residuals | Tungsten-free2
[minimal or no risk of interactions]
- Minimized particle levels3
[reduced risk of interactions]
Precise Attributes for Stable Fill-Finish Operations
- RFID in needle shield
[enhanced tracking and traceability of single containers during fill-finish/supply chain]
- High dimensional quality
[reliable filling and plunger fit reduce risk of line stop]
- Strong mechanical durability4
[for stable filling operations and minimized risk of breakage]
- High cosmetic quality
[lower risk of rejection at final inspection]
- Strong container closure integrity (CCI)5
[reduced risk of leakage and down time]
Designed for Easier and Safer Administrations
- Smooth plunger performance6
[low variability in break-loose and glide force]
- Individual needle verification for precise penetration
[100% inspection of needle angularity and tip | needle siliconization precisely monitored]
- Safer handling
[firm connection to standard hypodermic needles7 | proper torque and pull-off force | needle stick injury prevention system]
Accurate Fit and Smooth Functionality with Auto-injectors
- Accurate dimensions8
[enable precise integration and functionality with a wide range of auto-injector platforms]
- Consistent inner diameter and wall thickness of glass barrel9
[to support uniform and accurate dose delivery]
- Strong mechanical durability8,9
[provides robust performance and stability during use with automated injection systems]
Advanced Service Levels and Extended Documentation
- Efficient acceptance of delivered goods
[certificate of analysis | certificate of sterility | additional certificates upon request]
- Regulatory data for standards compliance
[physical and chemical properties compliant with pharmacopeia | level of sub-visible particles | risk analysis]
- Readily available trial samples
[helps validation of packaging, supports a fast time-to-market]
- Drug master file (DMF) data
[registered with FDA, Health Canada, and NMPA | easy procedure to receive LOA]
Recommended Syringe Range
| Specifications for self-administration solutions | |
|---|---|
| Quality level | ENHANCE |
Syringe tip | Staked needle |
| Syringe size | 1 long | 2.25 mL |
| Closure material | 4800 GS | FM30 | 7025/65 | |
| Stopper material | Datwyler | West | Gore10 |
| Silicone amount (mg) | 0.35 to 0.55 | Silicone oil free10 |
| Flange type | Small round |
| Staked needle | 27G/29G | ½" | Thin wall/Extra thin wall |
| Options | Backstop | RFID tag in needle shield | Backed-on silicone |
Footnotes
- Amount and distribution controlled, 100% in-line
- Only for Luer syringes
- Use of light-obscuration test for 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 for careful cosmetic inspections
- Laser-based cutting, precise forming process
- X-ray inspection
- Silicone-influenced parameters were carefully tested (break-loose force, glide force, particle level, container closure integrity)
- ISO 11040-4 Luer cone breakage resistance compliant
- 100% in-line camera inspection of a broad range of dimensional specifications (such as shoulders, length, neck)
- High-quality glass tubing
- 1 mL long only
Related products
Glass Cartridges
Designed for Precise Integration into Pen Systems
- Accurate dimensions15
[enable precise integration and functionality with pen systems]
- Consistent inner diameter and wall thickness of glass barrel16
[supports accurate dose delivery]
- Strong mechanical durability15,16
[for stable use with pen injection systems]
Excellent Cosmetic Quality
- High cosmetic quality17
[for reduced risk of rejects due to glass defects]
- Pristine appearance
[contributes to higher acceptance by end-user]
Extended Data Package for Fast Acceptance of Goods
-
Fast acceptance of delivered goods is facilitated
[CoA18 | CoS19 | additional certificate upon request]
-
Regulatory data confirms compliance with standards
[physical & chemical properties | compliant to pharmacopeia | level of sub-visible particles | risk analysis]
-
Drug Master File related data
[for FDA, Health Canada, and NMPA | easy procedure to receive LoA20]
Footnotes
11. 100%, in-line camera inspection of a broad range of dimensional specifications (such as shoulders, length, neck)
12. High-quality glass tubing
13. 100%, in-line camera inspection of a broad range of cosmetic parameters (such as stones, knots, inclusions, scratches, particles)
14. Certificate of Analysis (CoA)
15. Certificate of Sterility (CoS)
16. Letter of Access/Authority
Recommended Cartridge Range
| Specifications | |
|---|---|
| Quality level | ENHANCE |
| Cartridge size (mL) | 1.8 | 3.0 |
| Glass color | Clear |
| Ceramic | |
| Packaging | Bulk |
Related products
Primary Packaging Solutions for
Self-Administered Drug Products for Treating Chronic Diseases.
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 [email protected] |
| Submit a detailed inquiry: Contact per expertise |
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