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PHARMACEUTICAL

Description

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The Terumo Injection Filter Needle is a new needle within Terumo’s portfolio – indicated for hypodermic and intravitreal injections.

Verified and validated for intravitreal applications and developed for those working to improve safety, precision and patient experience, for injection into sensitive areas such as the vitreous. Terumo has developed a hypodermic needle with a considerably broadened set of features and indication for use – addressing advanced therapies of burdensome diseases


Addressing unmet needs

  • Growing rates of eye diseases such as neovascular age-related macular degeneration, diabetic retinopathy and retinal vein occlusions are driving demand for safer injections into the vitreous body (eye)1,2.
  • Today many injections to sensitive areas are currently performed using “off-label” hypodermic needles that are not designed or validated for these applications3.

Characteristics

The Terumo Injection Filter Needle is indicated to inject fluids into parts of the body below the surface of the skin, including subcutaneous, intramuscular, and intravascular applications as well as injections into the vitreous. The integrated 5μm polyamide mesh filter in the hub is intended to prevent particles from being injected into the patient. The Terumo Injection Filter Needle has been subject to stringent and extensive testing to determine biological properties and filtration performance.

Product Features

  • Integrated 5μm mesh filter
  • 30G-12mm extra-thin wall cannula
  • Soft blister packaging for aseptic presentation

Regulatory Status

  • CE Marking (EU)
  • 510(k) Clearance and Device Listing (United States)
  • Health Canada Registration (Canada)
  • PMDA Registration (Japan)*
  • ARTG Conformity Assessment (Australia)

Preparation


General Specifications

Terumo Injection Filter Needle


Specification Description
Cannula Stainless steel type X5CrNi18-10 (ISO 15510 / EN 10088-1)
Needle Gauge 30G
Needle Outer Diameter 0.3mm
Needle Length 12mm / ½”
Wall Thickness Extra-Thin Wall (ETW)
Bevel Angle 12o
Hub Polymethylmethacrylate and color masterbatch
Filter Polyamide, 5μm mesh opening
Lubricant Silicone oil lubricant (European Pharm. 3.1.8.)
Sterility Sterilized with Ethylene Oxide gas, in package via validated sterilization process (EN ISO 11135) achieving a Sterility Assurance Level of at least 10-6
Protector Polypropylene
Plunger rod Polypropylene
Adhesive Acrylic glue (UV cured)
Products do not contain components made of natural rubber latex CE 0197

Biological properties:


Biological evaluation has been performed in accordance with EN ISO 10993-1.

Particle levels:

When tested with the light obscuration particle count method according to EP 2.9.19, USP 788 (method 1) and USP 789, the average number of sub-visible particles found in the needles does not exceed:

  • Particles ≥10 μm: Not more than 10 particles per device
  • Particles ≥25 μm: Not more than 1 particle per device
  • Particles ≥50 μm: Not more than 0 particles per device

Sterility:

  • Products are supplied STERILE
  • The sterile barrier system meets the requirements of EN ISO 11607-1
  • The packaging process is validated in accordance with EN ISO 11607-2
  • Needles are sterilized with Ethylene Oxide gas, in package
  • Using a validated sterilization process5 (EN ISO 11135) to assure a Sterility Assurance Level of at least 10-6 (EN 556-1)

Downloads

Relevant product information
Link to Terumo_IFN Datasheet_2025

References

* not registered in any other jurisdiction.

1. VEHSS Modeled Estimates for Age-Related Macular Degeneration (AMD) | Vision and Eye Health Surveillance System | CDC

2. Age-Related Macular Degeneration (AMD) Tables | National Eye Institute

3. Subcutaneous Injections: Where and How To Give


Disclaimers

  • INFINO™ is a trademark filed by Terumo Europe N.V. for medical devices to be developed with specific features, the first example of these products is currently marketed as "Terumo Injection Filter Needle"
  • The Terumo Injection Filter Needle is a sterile medical device for single use intended to inject fluids. The indications for use are for general application – for treatment – injection of fluids into parts of the body below the surface of the skin and into the vitreous
  • In case of injection of fluids into the vitreous, the Terumo Injection Filter Needle shall be used only in combination with (pre-)filled syringes validated for intravitreal use
  • This information is intended for professionals in the pharmaceutical supply chain who are interested in primary packaging, injection components and medical devices from Terumo Pharmaceutical Solutions, for use in combination with their respective drug products (hereafter, pharmaceutical professionals). Please note that the product information contained on this data sheet is exclusively addressed to pharmaceutical professionals. This product information is not for the general public, nor is it intended to be a substitute for professional medical advice or for the care that patients receive from their healthcare professionals
  • Please note that some products may not be available in all regions, please reach out to your local Terumo Medical Care Solutions – Pharmaceutical contact for details
  • All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties
  • Images are for visualization purpose only
  • Always consult the product label and instructions for use for a complete overview of complications, warnings, cautions and precautions prior to actual use

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