Mass testing system

performancequalificationflow

Overview
The Andersen Cascade Impactor (ACI) system is designed for Aerodynamic Particle Size Distribution (APSD) testing of Dry Powder Inhalers (DPIs) and for Delivered Dose Uniformity (DDU) studies. ACI testing is commonly performed with a preseparator between the induction port and stage 0 to remove large, non-inhalable carrier particles and avoid impactor over-loading. Delivered dose tests for DPIs are frequently run at a flow rate corresponding to a 4 kPa pressure drop across the device to approximate mean patient inhalation.

Key components / system items

• Andersen Cascade Impactor (ACI)
• ACI Preseparator
• USP Induction Port
• Mouthpiece Adapter
• ACI Collection Plate Rack
• ACI Carrying / Washing Rack
• ACI Conversion Kit
• Quick Clamp (ACI)

Accessories & related equipment

• Critical Flow Controller TPK 200iX
• High Capacity Vacuum Pump HCP7
• Flow Rate Sensor (FRS)
• Flow Meter DFM 2000
• Inhaler Testing Workstation (ITW)
• Inhalytix®+ APSD Data Analysis Software
• Temperature and Relative Humidity Sensor
• Footswitch
• Label Printer

ACI Preseparator
The ACI Preseparator captures the large mass of non-inhalable powder boluses emitted from powder-based inhalers before they enter the impactor. This reduces stage overload and improves APSD measurement reliability. Preseparators are available for standard DPI test flow rates of 28.3, 60 and 90 L/min.

Induction Port P1 Measurement Adapter
Used with a Critical Flow Controller, the Induction Port P1 Measurement Adapter is positioned between the inhaler and the induction port to measure the pressure drop (P1) across the inhaler without a DUSA, enabling accurate DPI flow characterization.

Related applications

• Aerodynamic Particle Size Distribution (APSD) measurement of Dry Powder Inhalers (DPIs)
• Delivered Dose Uniformity (DDU) testing
• IVIVC test systems for realistic DDU and APSD
• Inhaled dissolution and formulation development studies
• Support for USP monographs and generic drug development

Caractéristiques / spécifications techniques

• Purpose: APSD testing of DPIs using Andersen Cascade Impactor (ACI)
• Preseparator function: captures large non-inhalable carrier particles before stage 0 to prevent impactor over-loading
• Preseparator flow rate options: 28.3 L/min, 60 L/min, 90 L/min
• Typical test flow condition: set on basis of a 4 kPa pressure drop across the device to approximate clinical inhalation flow
• Induction Port P1 Measurement Adapter: measures pressure drop (P1) across inhaler when used with a Critical Flow Controller
• Compatible ancillary equipment: critical flow controllers, vacuum pumps, flow sensors/meters and APSD data analysis software