Product Specifications
|
Parameter |
Standard Configuration |
|
Device Format |
Prefilled multi-dose disposable insulin pen |
|
Primary Container |
Integrated, non-replaceable 3.0 mL cartridge |
|
Total Insulin Capacity |
300 U in the standard U-100 configuration |
|
Dose Range |
1-60 U |
|
Dose Increment |
1 U per setting |
|
Maximum Single Dose |
60 U (0.6 mL in the standard U-100 configuration) |
|
Pen Weight |
20 g |
|
End-Of-Content Control |
Last-dose restriction with a non-resettable dose mechanism |
|
Packaging |
Sealed foil pouch |
|
Shelf Life |
2 years in the sealed package |
Key Advantages
● Integrated 300 U Prefilled Cartridge
The standard pen contains 300 U in an integrated, non-replaceable cartridge. Users do not need to load a cartridge, rewind the piston or reassemble the holder before first use.
● 1-60 U Variable Dose Setting
The standard mechanism allows doses from 1-60 U and includes a visible counter with push-button delivery. A new dose can be selected before the plunger advances when the prescribed amount changes between injections.
● End-Of-Content And Anti-Reuse Control
The dose train follows the available piston travel and limits the final selectable dose to the insulin remaining. Once the usable volume is exhausted, the mechanism cannot be reset for a new cartridge, which prevents reuse of the disposable pen body.
Customization Options
The non-replaceable cartridge and dose train are calibrated as one prefilled insulin system. Concentration, usable volume, dose increment, maximum dose, priming and last-dose restriction all refer to the same piston travel. The cartridge, stopper and piston interface are then matched to the selected fill-finish and final-assembly process.
The dose window, push button, grip, cap and external markings can be adapted for handling and product identification. These changes distinguish the finished insulin product without altering the released dosing mechanism or anti-reset structure.
Customization Process
Input Confirmation
The insulin concentration, cartridge and dose range are approved before the dose mechanism is developed.
Mechanism Calibration
Piston travel and scale movement are calibrated together, including the priming allowance and the point at which the final selectable dose is limited.
Prototype Assembly
Functional samples are assembled with representative cartridges to check dose setting, delivery and end-of-content behavior.
Verification Testing
Delivered volume is measured at defined dose points and cartridge positions. The results support design release.
Pilot Production
Pilot manufacture checks cartridge installation, molding capability and the final inspection method under production conditions.
Batch Release
Approved drawings and control limits govern batch production, final functional checks and lot traceability.
Quality Control
The cartridge, stopper and piston interface are checked together before assembly. The dose screw and display window are measured at the dimensions that control the selected and delivered dose. Functional testing follows the pen from first use through the final available dose, covering the approved dose points, priming and last-dose restriction; button force is added where required by the specification. Every completed pen is checked for appearance, assembly, dial movement and delivery function before packing, and the inspection record remains linked to its production lot.
FAQ
Q1: What is the MOQ?
A1: The standard MOQ is one full-container production lot. Mixed colors or models are possible only when each version meets the minimum material-feed and assembly quantity.
Q2: What packaging options are available?
A2: Pens can be packed in trays, pouches, blisters, cartons or project-specific retail packs. The final approved pack must protect the dose mechanism and meet export-shipping requirements.
Q3: What is the standard pen weight?
A3: The published standard configuration weighs 20 g. Final weight can change with the cartridge, housing material and external components selected for the project.
Q4: What shelf life is listed for the standard version?
A4: The published standard version lists a two-year shelf life in a sealed foil pouch. The labeled shelf life for a commercial project is confirmed from the final container, assembly and packaging configuration.
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