Optimized for NFCs with Central Pin
Needle free connectors (NFCs) are widely implemented in intravenous therapy to reduce needlestick injuries and simplify & standardize access to infusion lines. Nevertheless, several NFC designs feature a central pin that can interfere with the narrow internal tip-channel of conventional luer lock glass pre-fillable syringes (PFS). This incompatibility may lead to flow obstruction, incomplete connection, or even breakage at the connector interface. Pharmaceutical Companies are exposed to a higher risk of late‑stage redesigns, testing delays, device‑related complaints (in clinical trials and on the market), reputational damage, or even product recalls. Healthcare Professionals (HCP) and Patients may face compromised medication delivery, treatment delays, and increased safety risks.
The Solution: D2F™ Pre‑fillable Glass Syringes – LInC™ with Enlarged Tip-Channel (D2F™ PFS LInC™ - ETC)
D2F™ PFS LInC™ - ETC are engineered specifically for compatibility with needle‑free connectors featuring a central pin. The syringes incorporate a minimum inner tip‑channel diameter of 1.6 mm, ensuring reliable engagement and unobstructed flow with NFCs using a central pin. All performance attributes including, OD tip dimensions, robustness, container closure integrity (CCI) and functional behavior remain identical to the standard D2F™ LInC™ PFS platform.
D2F™ PFS LInC™ - ETC provide a more compatible, safer, and future ready delivery platform for pharmaceutical companies, HCPs and patients.
Compatible with NFCs with Central Pin
Supports a More Streamlined Development Process
Smooth Fill-and-Finish Integration
Reduces Risks of Product Complaints in Trials and on the Market
Safer, More Reliable and Lower Risk Clinical Connections for HCPs and Patients
Specifications
Compatible with NFCs with Central Pin
The enlarged PFS tip channel features a minimum inner diameter of 1.6 mm. This increased ID provides sufficient clearance for the outer diameter of the NFCs central pin, ensuring proper accommodation of the pin and enabling a smooth, reliable connection.
Support a More Streamlined Development Process
D2F™ PFS LInC™ - ETC are compatible with NFCs with central pin, thereby prevent unforeseen compatibility issues when being used at a later stage during clinical trials. This can reduce late-stage redesigns, avoid verification delays, and limit device-related issues during clinical trials. A validated administration interface from the start also supports faster, more efficient regulatory submissions keeping your program on a smoother path to market.
Smooth Fill-and-Finish Integration
Designed to fit seamlessly into existing fill-and-finish operations, D2F™ PFS LInC - ETC feature only one modification: an enlarged inner diameter of the tip channel. They deliver the same functional performance as conventional PFS and comply with all applicable ISO standards. Parameters that could potentially be affected by the enlarged tip channel, such as tip mechanical robustness, long-term container closure integrity (CCI), and performance of the LInC™ closure have been thoroughly tested. The results confirm full compliance with relevant standards. As a result, D2F™ PFS LInC - ETC integrate as smoothly into your fill-and-finish process as standard PFS.
Reduce Risks of Product Complaints
Reducing the risk of product complaints starts with dependable performance at the point of care (e.g., in acute and chronic care settings). By ensuring consistent, reliable function when PFS are used with NFCs with central-pin, the solution helps minimize device-related issues in routine clinical use and the associated complaints.
Safer, More Reliable, and Lower Risk Connections for HCPs and Patients
A secure connection is critical for safe, efficient needle-free IV therapy. By helping to ensure a complete connection, the system reduces the risk of leakage that can occur when interfaces are not fully engaged. It also minimizes the chance of unintended disconnection caused by dimensional mismatch, supporting more stable performance during use. In addition, it helps avoid breakage by addressing compatibility between the needle-free connector’s central pin outer diameter and the syringe tip inner diameter.
The result is a simple “one-fits-all” connection experience that provides peace of mind for both healthcare professionals and patients while supporting a smoother, easier workflow for healthcare workers in everyday clinical practice.
D2F™ PFS LInC™ - ETC help pharmaceutical companies reduce risk, accelerate development and improve user acceptance without disrupting fill‑finish operations.
Standard Product Range
Syringe
| Syringe - Volume (mL) | Syringe - Barrel OD (mm) | Flange - Round | Flange - Small round | Flange - Cut | Glass Tubing Supplier | Quality Level |
|---|---|---|---|---|---|---|
| 1.0 std. | 10.85 | o | o | o | o | o |
| 1.25 | 10.85 | √ | √ | √ | NIPRO NSV51 / External | ENGAGE |
| 1.5 | 10.85 | o | o | o | o | o |
| 2.25 | 10.85 | √ | √ | √ | NIPRO NSV51 / External | ENGAGE |
| 3.0 | 10.85 | o | o | o | o | o |
√ = available | o = on request
Tip Cap
| Syringe - Volume (mL) | Datwyler - V9507 - FM30 | Datwyler - V9507 - FM27 | West - 3155 - 7025 | West - 3155 - 7028 |
|---|---|---|---|---|
| 1.0 std. | o | o | o | o |
| 1.25 | √ | o | √ | o |
| 1.5 | o | o | o | o |
| 2.25 | √ | o | √ | o |
| 3.0 | o | o | o | o |
√ = available | o = on request | FM27 = styrene butadiene containing natural rubber latex | FM30 = styrene butadiene; 7025/65 = polyisoprene-bromobutyl blend; 7028/55 = Polyisoprene
Components
| Plunger rod | Plunger Stopper | Backstop |
|---|---|---|
| 1 to 3 mL | 1 to 3 mL | 1 to 3 mL |
| Transparent | Formulations - Aptar: C2575, 6422GS | Transparent |
| Color (optional) | Formulations - Datwyler: V9258_FM257 & FM457 | Color (optional) |
| Formulations - West: 4023/50, PH701/50 Black |
Sterile Packaging Solution
NIPRO manufactures D2F™ syringes in technologically advanced production sites that are certified according to ISO 9001, ISO 15378, ISO 14001, and ISO 50001. Our fully automated cleaning and packaging process takes place in an ISO 7/ISO 8 cleanroom with 100% monitoring under laminar air flow.
Key-technologies
Less particles
Tub and nest are cleaned by ionized air before entering the D2F™ process
Optimal entrance of tub on filling line
100%, In-line camera inspected (nest full, closure on syringe present, correct Tyvek® placement)
High cosmetics quality for less risk of rejects at final inspection
No glass-to-glass contact in tub
Visual control that tubs were sterilized
ETO indicator on tub (color change from blue to green after ETO exposure)
NIPRO’S D2F™ packaging design is a smart, efficient choice that enables immediate and direct use on the filling line. In essence, Direct-to-Fill.
| Tub Lid | Tub Insert | Breather Bag | Outer Box | Pallet | Slip Sheet Insert | Syringes per Nest (pcs) | Tub Height (mm) |
|---|---|---|---|---|---|---|---|
| Tyvek® | Single (Tyvek®) | Single | Cardboard | Wooden (treated) | Optional | 100 | 96 (1 to 2.25 mL) |
| Double (Tyvek®) | Double | PP-well | Plastic | 120 (3 mL) |
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 |
View our manufacturing locations: Our global network |