The global prevalence of diabetes continues to rise, driven by lifestyle-related risk factors and an aging population. Consequently, the demand for advanced therapeutic solutions, such as insulin and GLP-1 receptor agonists, is increasing rapidly. These biologically active molecules are highly sensitive and require robust primary packaging, including vials, cartridges, and increasingly, prefilled syringes.
NIPRO offers a selective portfolio of high-quality primary packaging solutions designed to support stable fill-finish operations, seamless integration into pen systems, and reliable storage of diabetes 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 |
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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
D2F™ Glass Vials
Contributes to Stable Fill-finish Processes
- High dimensional quality11
[supports efficient fill-finish operations]
- Strong mechanical durability11
[reduces risk of vial breakage during filling]
- Very high cosmetic quality11
[lowers risk of rejects at final inspection]
Standardized Packaging Solutions for a Fast Time-to-Market
- Readily available trial samples
[to test packaging]
- D2F™ Tub&Nest configurations compatible with prevailing fill-finish lines
[to support easy integration and stable fill-finish processes]
- Proven technology
[D2F™ vials used widely by pharmaceutical leaders]
Standard Service Level and Documentation
- Data for efficient acceptance of delivered goods
[certificate of conformity | certificate of sterility]
- On-site customer support
[smooth integration of RTU vials on high-speed filling lines]
- Regulatory data for standards compliance
[physical and chemical properties compliant with pharmacopeia]
- Drug Master file data
[registered with FDA, Health Canada, NMPA | easy procedure to receive LOA]
Accurate Fit and Smooth Functionality with Auto-injectors
- Accurate dimensions11
[enable precise integration and functionality with a wide range of auto-injector platforms]
- Consistent inner diameter and wall thickness of glass barrel12
[to support uniform and accurate dose delivery]
- Strong mechanical durability11,12
[provides robust performance and stability during use with automated injection systems]
Footnotes
11. 100% in-line camera inspection of a broad range of dimensional specifications (such as shoulders, length, neck)
12. High-quality glass tubing
Recommended Vial Range
| Specifications | |
|---|---|
| Quality level | ENABLE |
| Vial size (mL) | 2 R to 30 R |
| Glass color | Clear |
| Silk screening | |
| Packaging | Bulk | D2F™ |
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Glass Cartridges
Designed for Precise Integration into Pen Systems
- Accurate dimensions13
[enable precise integration and functionality with pen systems]
- Consistent inner diameter and wall thickness of glass barrel14
[to support accurate dose delivery]
- Strong mechanical durability 13, 14
[for stable use with pen injection systems]
Excellent Cosmetic Quality
- High cosmetic quality15
[reduces risk of rejection 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
[CoA16 | additional certificates 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 LoA17]
Footnotes
13. 100%, in-line camera inspection for a broad range of dimensional specifications (such as shoulders, length, neck)
14. High-quality glass tubing
15. 100%, in-line camera inspection for a broad range of cosmetic parameters (such as stones, knots, inclusions, scratches, particles)
16. Certificate of Analysis
17. Letter of Access/Authority
Recommended Cartridge Range
| Specifications | |
|---|---|
| Quality level | ENHANCE |
| Cartridge size (ml) | 1.8 | 3.0 |
| Glass color | Clear |
| Ceramic | |
| Packaging | Bulk |
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Primary Packaging Solutions
for Diabetes Drug Products.
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