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Category: Pen Injector

2-Step PFS Autoinjector with Automatic Needle Shielding System

  • Engineered for Safety: Featuring a sophisticated hidden needle design and a robust automatic post-injection locking mechanism (≥ 60 N), the BH0001-PF2 effectively eliminates accidental needle-stick injuries.
  • Exceptional Dose Efficiency: With a delivery efficiency of ≥ 96.5% and a swift injection time of under 10 seconds, it provides consistent pharmacological efficacy even for varied drug viscosities.
  • Intuitive User Feedback: The device utilizes a simple three-step operation process integrated with clear visual and tactile (auditory) confirmation signals to guarantee successful dose completion.
  • Global Regulatory Readiness: Fully tested and compliant with ISO 11608-1 and ISO 11608-5 standards, ensuring it meets the rigorous quality requirements of global pharmaceutical partners.
  • Bespoke Manufacturing: BioauraHealth offers comprehensive customization for colors and exterior aesthetics, allowing the device to perfectly align with your brand's unique identity.

Description

Precision Prefilled Syringe (PFS) Auto Injector Series:

  • Our PFS pen injector series offers a sophisticated two-step injection solution for high-viscosity medications. Featuring models BH1001-PF, BH1002-PF, and BH1003-PF, these devices are engineered to handle viscosities up to 20 cP, ensuring reliable drug delivery for diverse therapeutic applications. Whether utilizing 1mL or 2.25mL prefilled syringes, each auto injector pen provides a stable fixed-dose administration.
  • The BH1000 series auto injection pen is designed with patient safety and comfort as a priority. Each injector pen is compatible with 27G/29GTW or smaller needles and features a controlled penetration depth of 6±2 mm. To ensure successful delivery, the series incorporates a dual feedback system providing both visual and auditory signals upon injection completion.
  • With customizable injection times and varied outer dimensions to fit different ergonomic requirements, our auto injector pen platform is a versatile choice for pharmaceutical manufacturers. From the compact BH1001-PF (145mm) to the larger-capacity BH1003-PF, we deliver high-precision medical devices that meet modern clinical standards.
Category Technical Specifications Details
Basic Info Product Model BH0001-PF2
Device Classification Disposable Auto Injector Pen
Regulatory Compliance ISO 11608-1 / ISO 11608-5 Standards
Performance Container Compatibility 1.0 mL Slim-Type Prefilled Syringe (PFS)
Fill Volume Range 0.2 mL – 1.0 mL
Dose Delivery Type Fixed Dose
Dose Delivery Efficiency ≥ 96.5%
Needle Gauge 29G TW or Larger
Needle Insertion Depth 6 ± 2 mm
Injection Time ≤ 10 seconds
Safety & UX Needle Safety Design Hidden needle with automatic post-injection locking
Feedback Mechanism Visual and Auditory Confirmation
Locking Force ≥ 60 N
Needle Safety Distance ≥ 4.5 mm
Manufacturing Production Capacity 100,000 Units / Month
Customization Options Color, appearance, and filling volume per formulation

Internal components and assembly process of a disposable medical auto injector Disposable medical auto injector pen for precise subcutaneous drug delivery

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