Testing of Nasal devices
Nasal device testing
Emmace offers testing of nasal products that require special instruments such as plume geometry, spray pattern methodology, laser diffraction and an assessment that indicates how much particles under 10 µm a dose contains, which is the portion that can reach the lung region. If required, an automatic nasal device fire station is used.
We offer testing using different inlets between the device and the NGI cascade impactor (or abbreviated impactor), se pictures below.
- Glas inlet, 1 and 2 liter
- Glas inlet on Fast Screening Impactor (FSI)
- Anatomical Nasal model (Nasal cavity + nasopharynx)
- Alberta Idealised Nasal Inlet (AINI)
- Kiel Nasal Inlet (KNI)
- Extended Anatomical Nasal model (Nasal cavity + nasopharynx + hypopharynx)
The deposition of powder or droplets can be studied in different nasal cavity designs, depending on what kind of questions to be answered,
- Fractionated deposition, nostril, middle, nasopharynx, and portion entering the hypopharynx region (A)
- Deposition in nasal region as one determination (B)
- Transparent version for visual confirmation of droplet deposition (C)
- Solid black design for visual confirmation of powder deposition (D, E)
We also provide testing according to required tests for nasal products given in “Guideline on the pharmaceutical quality of inhalation and nasal medicinal products”, EMA/CHMP/20607/2024.
