Anticoagulant drugs are vital products that prevent the formation of blood clots in high-risk individuals, such as patients undergoing surgery, people managing cardiovascular diseases, and those dealing with age-related conditions.
These are drug products that are widely used across the globe, and Nipro offers a dedicated range of packaging solutions with proven experience in accelerating time to market. Our packaging containers deliver consistently reliable quality, integrating seamlessly into the fill-finish process to ensure smooth and stable operations. By leveraging our extensive manufacturing network, we have the capacity to produce quantities large enough for this critical market segment.
D2F™ Pre-fillable Glass Syringes
Proven, standardized packaging solutions for a fast time-to-market
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Readily available trial samples
[to test packaging]
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D2F™ Tub&Nest compatible with prevailing fill-finish lines
[fast to run and easy integration]
-
Proven technology
[D2F™ Syringes used widely by pharmaceutical leaders]
Precise syringe attributes for fast and stable fill-finish operations
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High dimensional quality
[reliable filling and plunger fit]
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Strong mechanical durability1
[minimized risk of breakage]
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High cosmetic quality
[lower risk of rejection at final inspection]
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Strong container closure integrity (CCI)2
[reduced risk of leakage]
Smooth and safer in manual administration
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Smooth plunger movement3
[low variability in break-loose and glide force]
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Individual needle verification for precise penetration
[100% inspection of needle angularity and tip | needle siliconization precisely monitored]
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Safer handling
[firm connection to standard hypodermic needles4 | proper torque and pull-off force, needle stick injury5 prevention system]
Adapted service level and documentation
-
Data for efficient acceptance of delivered goods
[certificate of conformity | certificate of sterility]
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On-site customer support
[smooth integration of RTU syringes on high-speed filling lines]
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Regulatory data for standards compliance
[physical and chemical properties compliant with pharmacopeia]
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Drug master file data
[registered with FDA, Health Canada, NMPA | easy procedure to receive LOA]
Footnotes
- Glass tubing with consistent inner diameter, Laser-based cutting, precise forming process, 100% in-line camera inspections of dimensional parameters
- 100% in-line camera inspections of dimensional (inner diameter of syringe barrel, syringe tip) and physical (closure pull-off force) parameters
- Silicone-influenced parameters were carefully tested (break-loose force, glide force, particle levels)
- ISO 11040-4 Luer cone breakage resistance compliant
- Compatible with safety systems
Recommended Syringe Range
For Anticoagulant Drug Products | |
|---|---|
| Quality level | ENABLE |
| Syringe tip | Staked needle |
| Syringe size (mL/µL) | 0.5 | 1 long |
| Closure material | FM27 | 4800 GS |
| Stopper material | Aptar 6422 | West PH 701 | Datwyler FM 257 |
| Silicone amount (mg) | 0.7 per syringe |
| Flange type | Cut flange |
| Staked needle | 27 G, ½" - thin-wall |
| Options | Backstop, Safety system |
D2F™ Glass Vials
Contributes to Stable Fill-Finish
- High dimensional quality6
[for efficient fill-finish]
- Strong mechanical durability6
[reduced risk of vial breakage during filling]
- High cosmetic quality6
[lower 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]
Footnotes
6. High-quality glass tubing, 100% in-line visual inspection of cosmetic and dimensional parameters
Recommended Vial Range
For Standard | |
|---|---|
| Quality level | ENABLE |
| Vial size (mL) | 2 R to 30 R |
| Glass color | Clear |
| Silk screening | |
| Packaging | Bulk | D2F™ |
Standardized Primary Packaging Solutions
for a Fast Time-to-Market
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 |
View our manufacturing locations: Our global network |