Product Specifications
|
Parameter |
Standard Configuration |
|
Device Format |
Reusable mechanical insulin delivery pen |
|
Primary Container |
Replaceable 3.0 mL insulin cartridge |
|
Cartridge Capacity |
300 U in the standard U-100 configuration |
|
Dose Range |
1-60 U |
|
Dose Increment |
1 U per click |
|
Maximum Single Dose |
60 U (0.6 mL in the standard U-100 configuration) |
|
Needle Options |
Universal 4 mm or 6 mm pen needles |
|
Needle Attachment |
Manual screw-on connection |
|
Pen Weight |
25 g without the cartridge |
|
Carrying Case Capacity |
1 pen and 2 spare needles |
|
Mechanical Parts Warranty |
2 years |
Key Advantages
● 1 U Dose Setting From 1 To 60 U
The published standard configuration provides a 1-60 U dose range with one unit per click. The clear window and indexed dial let the selected amount be seen and counted before injection.
● 25 G Handheld Format
The pen weighs 25 g without the cartridge. Its compact body keeps the dose window, dial and push button easy to position during repeated handling in home-care and diabetes education programs.
● 3 ML Cartridge With 4 MM Or 6 MM Needle Options
The standard interface is listed for a 3 mL cartridge and universal 4 mm or 6 mm pen needles. The confirmed front connection keeps attachment consistent as needles are changed between injections.
Customization Options
The product can be developed as a reusable pen for replaceable 3 mL cartridges or as a prefilled format with a fixed container. This choice determines piston reset, container retention and final assembly. Dose increment, maximum dose, priming and last-dose behavior are then calibrated to the same piston and scale movement.
Grip diameter, dose-window layout, push-button geometry and the needle interface can be adjusted for repeated daily use. Color and printed identification can distinguish insulin variants without changing the approved dosing sequence.
Customization Process
System Input
The insulin concentration, 3 mL cartridge, needle interface and dose range are approved together as the project input.
Mechanism Design
Scale movement and piston travel are calibrated together. The force ratio and last-dose point are set around the selected cartridge.
Prototype Build
Functional pens are assembled with representative cartridges and needles so handling and dose delivery can be tested in the final interface condition.
Verification
Dose delivery, priming and operating force are tested at the settings and temperatures defined by the project.
Pilot Production
A controlled pilot lot checks molding, assembly and inspection methods before batch manufacture.
Batch Manufacturing
Released drawings and control limits govern production, final inspection and packing verification.
Quality Control
The cartridge holder, piston and needle interface are checked together because they establish the delivery path. The dose window and button components are measured where their dimensions affect setting and actuation. Verification uses the confirmed 3 mL cartridge and selected pen needle to measure dose delivery and operating force at defined cartridge positions; priming and correction are checked against the released limits. Completed pens receive appearance, assembly and operating checks before packing, and the records remain traceable to the released lot.
FAQ
Q1: Which shipping terms are available?
A1: EXW, FOB and CIF terms are available. The selected term is confirmed with the destination, packing plan and required shipping documents.
Q2: What is the lead time?
A2: Production lead time depends on the device format, order quantity and material schedule. New custom tooling and sample development normally require 40-60 days before pilot production.
Q3: What warranty is listed for the mechanical parts?
A3: The standard product page lists a two-year warranty for the mechanical parts. Covered components and service terms are confirmed with the supplied configuration.
Q4: Is a carrying case included with the standard product?
A4: Yes. The standard product page lists a carrying case that holds one pen and two spare needles. The approved packaging specification confirms the final pack list.
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