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Pre-filled Auto-Injector Combination Device (Two-Step Method)

The pre-filled auto-injector combination device primarily consists of three components: the pre-filled syringe (PFS), the pen body assembly, and the firing mechanism assembly. The medication is contained within the pre-filled syringe, which is then loaded into the pen body assembly. The pen body provides protection for the PFS against accidental breakage and features a large viewing window for easy observation of the drug solution. After the pen body is assembled with the firing mechanism, the injection is powered by a spring inside the firing mechanism to complete drug delivery.

Description

Customizable Design

  • Color Customization: Available in multiple standard colors. Custom color requirements can also be accommodated to meet market differentiation needs.

  • Filling Flexibility: Compatible with PFS products requiring different fill volumes and viscosities, reducing changeover costs.

  • Strong Adaptability: Compatible with mainstream PFS products from various suppliers on the market.

Product Performance Testing

  • Physical Performance Tests

    • Visual & Auditory Feedback

    • Cap Removal Force

    • Injection Activation Force

    • Needle Shield Locking Force

    • Needle Safety Distance

    • Air-Shot Needle Insertion Depth

    • Injection Time

    • Dose Delivery Efficiency

    • Leakage

  • Reliability Tests

    • Cold, Standard, & Warm Ambient Environment Tests

    • Free Fall Test

    • Dry Heat & Cold Storage Tests

    • Vibration Test

    • Simulated Transport Validation

  • Stability Tests

    • Accelerated Aging Validation

    • Real-Time Aging Test

    • Long-Term Cold Storage Stability

  • Biocompatibility Tests

    • In Vitro Cytotoxicity Test

    • Skin Sensitization Test

    • Skin Irritation Test

Key Parameters Description
Integrated Container Specification 1.0 mL Slim PFS
Fill Volume 0.2 – 1.0 mL
Injection Dose Fixed Dose
Needle Diameter 29 G TW or larger
Dose Delivery Efficiency ≥ 96.5%
Injection Time ≤ 10 s
Needle Insertion Depth 6 ± 2 mm
Injection Feedback Visual & Auditory
Shield Locking Force ≥ 60 N
Needle Safety Distance ≥ 4.5 mm