Next Generation Impactor NGI System
Category：Medical Device Tester
Introduction
The Inhalation Formulation Fine Particle Aerodynamic Characterization System is specifically designed for testing inhalation formulations. It complies with the instrument requirements of the USP, EP, and ChP (2020 edition) methods for aerodynamic particle size determination of inhalation formulations. This configuration enables testing of inhalation aerosols, including fine particle aerodynamic characterization, delivered dose uniformity, and other pharmacopeial-required tests.
Application
(1) Aerodynamic particle size distribution testing of inhalation aerosols and powders.
(2) Fine particle fraction evaluation for inhalation formulations.
(3) Delivered dose uniformity testing of inhalers.
(4) Research and development of inhalation drug delivery systems.
(5) Quality control testing of metered-dose inhalers (MDI), dry powder inhalers (DPI), and nasal sprays.
Main Components and Technical Specifications
|
Component |
Technical Specifications |
| 2.1 Next-Generation Pharmaceutical Andersen Cascade Impactor (ACI) Main Unit
|
– Includes 7 stages plus a Micro-Orifice Collector (MOC), easy to open and recover samples, ready for next test. – 8 removable collection cups; each stage cup can be removed for cleaning or replacement. – Suitable for testing inhalation powders, aerosols, sprays, and liquid formulations. – Collection cups serve as impactor surfaces, positioned under the nozzle on a tray for efficient sample collection. – Artificial Throat: stainless steel, dimensions meet pharmacopeial requirements. – Orifice Diameters: • Stage 1: 14.30 ± 0.05 mm • Stage 2: 4.88 ± 0.04 mm • Stage 3: 2.185 ± 0.02 mm • Stage 4: 1.207 ± 0.01 mm • Stage 5: 0.608 ± 0.01 mm • Stage 6: 0.323 ± 0.01 mm • Stage 7: 0.206 ± 0.01 mm • MOC: ~0.07 mm – Collection Cups: stainless steel, small and large cups depth 14.625 ± 0.1 mm, surface roughness Ra 0.5–2 μm, pharmacopeial compliant. |
| 2.2 Smart Suction Pump Pro | Flow adjustable 0–90 L/min, suction time 0.1–9999 s, noise ≤75 dB; suitable for inhalation aerosol testing. |
| 2.3 Pressure Measurement Device | Compliant with USP, EP, and ChP requirements. Measures: – Absolute atmospheric pressure PA (0–200 kPa) – Pressure drop across inhaler P1 – Pressure before and after flow control valve P2 & P3 and their ratio |
| 2.4 Aerosol Sampling Tube | Equipped with sealed sample collection tube to quantitatively collect delivered dose; dimensions compliant with USP, EP, ChP. |
| 2.5 Sampling Tube Base | Stainless steel base with screen for holding filter paper. |
| 2.6 Aerodynamic Particle Size Analysis Software* | Proprietary software with copyright certificate. Free upgrades and lifetime support. Calculates cut-off diameters at different flow rates, MMAD, and GSD of aerosol. |
| 2.7 2Q Validation Service | IQ/OQ validation service provided once. |
Basic Configuration
| Item | Quantity |
| Next-Generation Pharmaceutical ACI Main Unit | 1 |
| Collection Cups (6 small + 2 large) | 1 |
| Artificial Throat | 1 |
| Preseparator | 1 |
| Leak Detection Tool and Accessories | 1 |
| Inhalation Formulation Analysis Software V1.0 | 1 |
| Smart Suction Pump Pro (0–90 L/min Oil-Free Vacuum Pump) | 1 |
| Pressure Measurement Device | 1 |
| Flowmeter: TSI 0–200 L/min Low Resistance | 1 |
| Adapters (customized per user requirements) | 2 |
| Built-in Filter (for inhaled liquids, aerosols, nasal sprays) | 1 |
| Aerosol Sampling Tubes | 10 |
Features
The Next Generation Impactor (NGI) provides the following features:
(1) Multi-stage particle separation for accurate aerodynamic particle size distribution analysis.
(2) Seven impactor stages plus a Micro-Orifice Collector for precise fine particle collection.
(3) Removable stainless steel collection cups for easy cleaning and rapid sample recovery.
(4) Artificial throat designed according to pharmacopeial dimensional requirements.
(5) Smart suction pump with adjustable airflow and programmable suction time.
(6) Pressure measurement system for monitoring inhaler pressure drop and system performance.
(7) Dedicated inhalation formulation analysis software for automated MMAD and GSD calculations.
(8) Modular configuration suitable for powders, aerosols, sprays, and liquid inhalation products.
FAQ
1. What is this product?
The Impactor is a laboratory instrument used to measure the aerodynamic particle size distribution of inhalation aerosols and powders.
2. What is this product used for?
The Next Generation Impactor is used to evaluate inhalation drug delivery performance, including fine particle fraction and aerosol deposition characteristics.
3. What is the working principle of this product?
The Impactor separates aerosol particles by aerodynamic diameter through multiple impactor stages where particles are collected based on their inertia.
4. Why is this product important?
The NGI ensures inhalation drug products meet pharmacopeial requirements and provides accurate particle size distribution data.
5. What industries is this product suitable for?
The Next Generation Impactor is suitable for pharmaceutical manufacturers, inhalation drug developers, regulatory laboratories, and academic research institutions.
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