Product Specifications
|
Parameter |
Standard Configuration |
|
Device Format |
Electronic variable-dose drug delivery platform |
|
Dose Range |
1-80 U |
|
Dose Increment |
0.5 U per setting |
|
Maximum Selected Dose |
80 U (0.8 mL in a U-100 configuration) |
|
Primary Container |
Cartridge or reservoir selected for the drug formulation and dose profile |
|
Dose Display |
Backlit side LCD |
|
Dose Memory |
Previous-dose recall |
|
Display Power Life |
1 year |
|
Electronic Component Warranty |
2 years |
Key Advantages
● 0.5 U Dose Setting Across A 1-80 U Range
The published electronic configuration provides 0.5 U increments across a 1-80 U dose range. The display and selector show the selected amount before the injection stroke begins, which supports therapies that use smaller step changes.
● Backlit LCD Dose Display
A backlight is built into the side LCD. The selected dose remains readable at night or in other low-light treatment areas without relying only on dial position.
● Last-Dose Recall With One-Year Display Power
The display recalls the previous dose and has a listed one-year battery life. The last recorded setting can be checked before the next dose is prepared.
Customization Options
Configuration starts with the drug and primary container. Container format, dose range, increment and drive method are developed together so piston movement and operating force match the required delivery volume and formulation resistance.
Grip, display and operating feedback are arranged for the intended therapy and use sequence. External colors and markings can identify different strengths or formulations while the underlying device platform remains consistent.
Customization Process
Drug And Device Inputs
The formulation, primary container and dose profile are approved together as the technical specification for the device program.
Platform Selection And DFM
The dose architecture and force-management method are selected from those inputs, then checked for material, tolerance and assembly feasibility.
Prototype Development
Functional devices are built with representative containers and test media so delivery and handling can be assessed in the intended configuration.
Design Verification
Delivered volume, injection force and interface fit are measured against the approved limits across the defined operating conditions.
Pilot Production And Validation
Pilot manufacture checks tooling capability, assembly controls and the test method under production conditions.
Commercial Production
Released drawings and the control plan govern manufacture of components, subassemblies or complete devices.
Quality Control
Materials adjacent to the drug container are checked against the released specification. The piston support and needle connection are measured at the dimensions that control device fit. Functional evaluation uses the approved container and representative test medium to relate delivered volume to injection force and time, with separate acceptance limits established for each formulation-container combination. Molding, assembly and inspection records are retained by production lot. Final devices are checked before packing, and third-party inspection is included when stated in the order plan.
FAQ
Q1: How long does custom sample development take?
A1: Tooling and sample development generally require 40-60 days. The schedule depends on the dose mechanism, part count, container interface and verification program.
Q2: Can you provide a reference sample before tooling?
A2: A basic reference sample can be provided when available. Drug-specific functional samples are produced after the input specification and prototype or tooling cost are confirmed.
Q3: What warranty is listed for the electronic components?
A3: The standard product page lists a two-year warranty for the electronics. Covered parts and service terms are defined in the order agreement.
Q4: Who is responsible for final combination-product registration?
A4: The pharmaceutical sponsor or market authorization holder controls the final drug-device submission. The agreed device manufacturing scope may include drawings, material data, verification records and production documents required by the technical file.
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