The global demographic shift toward an aging population is intensifying the demand for advanced therapeutics targeting chronic diseases, such as cardiovascular disorders and autoimmune conditions. In response, the pharmaceutical sector is accelerating the development of biologic and biosimilar drug products, which offer targeted mechanisms of action and improved clinical outcomes for complex disease states.
Many biologic drug products require specialized primary packaging due to their sensitivity to materials such as silicone oil particles and tungsten residues. Additionally, a significant number of chronic disease therapies are now marketed as combination products. These integrated delivery systems demand primary containers that are precisely compatible with auto-injectors and pen injectors, contributing to consistent performance, reliability, and ease of use for patients.
At NIPRO, we provide fully customizable primary packaging solutions tailored to the specific characteristics of each drug product and the operational requirements of our pharmaceutical partners.
D2F™ Pre-Fillable Glass Syringes
Optimized Compatibility between Advanced Drug and Container
- Low silicone homogeneously distributed | Silicone oil free1
[reduced risk or no risk of drug-container interactions due to particles]
- Low tungsten | Tungsten-free2
[minimized or no risk of drug-container interactions due to residuals]
- 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 stops]
- 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 downtime]
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
[supports uniform and accurate dose delivery]
- Strong mechanical durability8,9
[provides robust performance and stability during use with automated injection systems]
- Compatibility tested with prevailing auto-injectors
[certificate of compatibility and related data supporting faster time to market]
Extensive Service and Documentation
- Efficient acceptance of delivered goods
[certificate of analysis | certificate of sterility | additional certificates/data 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
[facilitates 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]
- Intense collaboration with cross-functional team of experts (technical, RA&QA, lab services)
[from container selection, over joint development to commercialization]
Recommended Syringe Range
| For manual administrations | For auto-injectors | |
|---|---|---|
| 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 | Round | Cut | 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 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 for a broad range of dimensional specifications (such as shoulders, length, neck)
- High-quality glass tubing
- 1 mL long only
Related products
D2F™ Glass Vials
Contributes to Stable Fill-finish Processes
- High dimensional quality
[enables efficient fill-finish]
- Strong mechanical durability
[reduces risk of vial breakage during filling]
- Very high cosmetic quality
[lowers risk of rejection at final inspection]
- Optional UID for single container tracking11
[enables track-and-trace of single containers]
Lower Risk of Drug/Container Interactions
- VIALEX™ – Significantly reduced risk of interactions with the inner glass surface12
[more stable drug storage] - VIALEX™ – Reduced risk of glass delamination12
[longer shelf-life potential] - Silicone coating on inner surface of vial (optional)
[barrier between drug product and inner vial]
- Amber glass for light-sensitive medicines
- Glass tubing in ENHANCE quality
[Type I, Borosilicate, 51 expansion | high dimensional and cosmetic quality]
Enhanced Lyophilization Process
- VIALEX™ – Optimized lyophilization process13
[reduces fogging]
Advanced Service Levels and Extended Documentation
- Data for efficient acceptance of delivered goods
[certificate of analysis | certificate of sterility | additional certificates on request]
- Regulatory data for standards compliance
[physical and chemical properties compliant with pharmacopeia | level of sub-visible particles | risk analysis] - Readily available trial samples
[facilitates test packaging, supports a fast time to market]
- Drug master file-related data
[registered with FDA, Health Canada, and NMPA | easy procedure to receive LOA]
Footnotes
11. Print of 2D data matrix code on vial barrel
12. Results of long-term study – 24 weeks at 40°C: Phosphate, High purity water, Citrate, NaCl with terminal sterilization
13. Results of Simtra Biopharma Solutions study: Introduction to Vial Fogging and Mitigation Strategies Kevin Bond, Research Associate II – Inc. Live Webinar Transcription, 2022
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. Enhanced durability results in lower levels of extractables and leachables (E&L), thereby 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, contributing to a prolonged shelf life.
Recommended Vial Range
Footnotes
14. Optional
| Specifications | |
|---|---|
| Quality level | ENHANCE | ENGAGE |
| Vial size (mL) | 2 R to 30 R |
| Glass color | Clear | Amber |
| Inner surface treatment | VIALEX™ |
| Silk screening | 2D data matrix code | |
| Packaging | Bulk | D2F™ |
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
[support accurate dose delivery]
- Strong mechanical durability15,16
[supports stable use with pen injection systems]
Excellent Cosmetic Quality
- High cosmetic quality17
[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
[CoA18 | 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 LoA19]
Footnotes
15. 100%, in-line camera inspection for a broad range of dimensional specifications (such as shoulders, length, neck)
16. High-quality glass tubing
17. 100%, in-line camera inspection for a broad range of cosmetic parameters (such as stones, knots, inclusions, scratches, particles)
18. Certificate of Analysis
19. 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 Advanced Chronic Disease Drug Products.
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E-mail us [email protected] |
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