- Growing rates of eye diseases such as neovascular age-related macular degeneration (AMD), diabetic retinopathy and retinal vein occlusions (RVO) are driving demand for safer injections into the vitreous body (eye)1,2.
- Today, many injections in sensitive areas are performed using hypodermic needles that are not specifically designed or validated for these applications3.
Terumo Injection Filter Needle
Terumo Injection Filter Needles
- Integrated 5μm mesh filter
- 30G-12mm extra-thin wall cannula
- Soft blister packaging for aseptic presentation
- Patented design developed as part of the Terumo INFINO development program.
- CE certified: CE 0197
- 510(k) Clearance and Device Listing (United States)
- Health Canada Registration (Canada)
- PMDA Registration (Japan)*
- ARTG Conformity Assessment (Australia)
- Biological evaluation has been performed in accordance with EN ISO 10993-1.
* item code not registered in any other jurisdiction.
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
- 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 their final package
- Ethylene oxide sterilization Sterility Assurance Level (SAL) at least 10-6
Specifications for Terumo Injection Filter Needles
Global Solutions for Injection Filter Needles
The Injection Filter Needles are available to drug product manufacturers globally.
For more information about product availability, specifications, and applicable standards, download our data sheet.
Please note that some products may not be available in all regions, reach out to your local Terumo Pharmaceutical Solutions Pharmaceutical Contact for details. All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties.
Terumo Injection Filter Needle Product Information
References
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. Annersten, M., & Willman, A. (2005). Performing Subcutaneous Injections: A Literature Review
4. Langille, S. E. (2013). Particulate Matter in Injectable Drug Products. PDA Journal of Pharmaceutical Science and Technology, 67(3), 186–200. PDA Journal of Pharmaceutical Science and Technology, May 2013, 67(3), 186–200
5. Perez, M., Maiguy-Foinard, A., Barthélémy, C., Décaudin, B., & Odou, P. (2016). Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients. Pharmaceutical Technology in Hospital Pharmacy, 1(2), 91–103. Pharm. Technol. Hosp. Pharm. 2016; 1(2): 91–103
6. Messick, S., Saggu, M., & Ríos Quiroz, A. (2019). Particles in Biopharmaceuticals: Causes, Characterization, and Strategy. In Biopharmaceutical Processing (Springer)
Terumo Injection Filter Needle Product 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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