Mass testing system

performanceflowfor medical devices

Overview
Nasal sprays typically produce droplets in the range 20-200 microns to ensure nasal deposition and minimise lung deposition. A respirable fraction of fine droplets (<10 microns) can be produced (typically <5%) and needs quantification. Aerodynamic particle sizing (APSD) with a cascade impactor is a US FDA requirement and is recommended in USP <601> to assess potential deposition beyond the nasal cavity.

Recommended test configuration

• Use of a cascade impactor (e.g. Next Generation Impactor, NGI) to measure aerodynamic particle size distribution.
• Use of a high-volume expansion chamber (Glass Expansion Chamber) to enable representative recovery of spray aerosol for impactor measurement.
• Controlled shake, fire and flow actuation using an automated system (Vertus® range) to achieve reproducible device actuation.
• Optional integrated analytical balance for automated shot weight measurement with Vertus® III+.

Vertus® range capabilities

• Automated and integrated shake, fire and flow control for consistent nasal spray actuation.
• Control of shaking parameters: speed, angle and duration prior to actuation.
• Control of firing parameters: firing force, application/release speed and timing.
• Control of the delay between the end of shaking and device actuation to standardise sample collection.
• Vertus® III+ includes an integrated analytical balance for automated shot weight measurement.

Manual testing support

• Products to support manual testing include flow meters, flow controllers and vacuum pumps.
• Angled Nasal Device Holder (cat. no. 8143) enables precise orientation of nasal spray devices at selectable firing angles (±45°) to support consistent APSD assessment.

Related accessories and systems

• Next Generation Impactor (NGI) and related NGI accessories (cup rack, carrying/wash rack, tilting platform).
• Glass Expansion Chamber and associated stands/holders.
• Adapters and clamps for device mounting and impactor interfaces.
• Vertus® II / Vertus® Plus / Vertus® III automated systems and related semi-automation tools (Gentle Rocker, NGI Assistant, Impactor Cleaning System, etc.).

Video
There is an explanatory video available titled "How Does a Cascade Impactor Work?" that demonstrates cascade impactor function and APSD measurement principles.

Caractéristiques / spécifications techniques

• Droplet size range typically produced by nasal sprays: 20–200 microns.
• Respirable fine droplet fraction to quantify: droplets <10 microns (typical proportion <5%).
• Regulatory guidance: Aerodynamic particle sizing with a cascade impactor required by US FDA and recommended in USP <601> for nasal sprays to assess potential lung deposition.
• Recommended impactor: Next Generation Impactor (NGI) or equivalent cascade impactor.
• High-volume expansion chamber (Glass Expansion Chamber) recommended for nasal spray APSD testing to enable collection of coarse spray while allowing impactor measurement of fine fraction.
• Vertus® automated systems provide reproducible actuation by controlling shake (speed/angle/duration), firing force and timing; Vertus® III+ adds integrated analytical balance for shot weight.
• Manual testing accessories: flow meters, flow controllers, vacuum pumps, nasal device holders (angled holder supports ±45° orientation).