Leakage testing system

massperformancecompatibility

Overview
Delivered dose (DDU) testing of nebulisers determines the total amount of drug a patient is expected to receive during a defined treatment period rather than from a single actuation. DDU testing for nebulisers assesses dose delivery over time and is typically performed using realistic breathing simulation to generate representative test conditions consistent with pharmacopoeial requirements.

Testing approach
DDU testing of nebulisers characterises both the rate and total amount of active substance delivered during a treatment period. The pharmacopoeial tests commonly used to describe delivered dose include Active Substance Delivery Rate and Total Active Substance Delivered. These tests are performed under well-defined tidal (breathing) flow conditions generated by a breathing simulator rather than by fixed flow rates to better reflect patient use.

Equipment and components

• Breathing simulators (used to generate tidal breathing profiles appropriate for different patient types).
• Filter holders and collection filters used to capture delivered dose for recovery and analysis.
• Mouthpiece and nosepiece adapters to permit testing of facemasks, mouthpieces or nasal interfaces.
• Sample preparation and automation ancillaries to support recovery, rinsing and solvent compatibility during analytical recovery workflows.

Advanced Filter Holder (featured)
The Advanced Filter Holder is described on the page as a purpose-designed accessory to improve efficiency and robustness in DDU testing of nebuliser products and MDIs with spacers/valved holding chambers. Key functional points for this component are presented below.

• Single-piece, hinged design for leak-free operation enabling simplified filter replacement and in-situ rinsing.
• Manufactured from the same material as Copley DUSA tubes to ensure solvent compatibility during recovery and cleaning.
• Durable, leak-free construction intended to streamline sample recovery workflows.
• Compatible with sample preparation automation (noted compatibility with Sample Preparation Unit SPU 200i for automated recovery processes).

Products featured in the system and related accessories
Examples of equipment referenced as part of DDU and nebuliser testing workflows include:

• Breathing Simulator BRS 200i (breathing profile generation for tidal flow testing).
• Mouthpiece adapter (for connecting device interfaces to the test train).
• Advanced Filter Holder (collection and recovery of delivered dose; supports rinsing and solvent compatibility).

Applications
The DDU of nebulisers workflow is used to support delivered dose, active substance delivery rate and total active substance delivered testing in line with relevant pharmacopoeial requirements. Testing is applicable to product development, validation and comparative studies where delivered dose over a treatment period is a critical attribute.

caractéristiques / spécifications techniques

• Purpose: Delivered Dose Uniformity (DDU) testing of nebulisers — measures delivered dose over a defined treatment period.
• Test conditions: Tidal breathing profiles (patient-specific), generated by breathing simulators rather than fixed flow rates.
• Pharmacopoeial endpoints: Active Substance Delivery Rate; Total Active Substance Delivered.
• Key components: Breathing simulator, filter holder (Advanced Filter Holder), mouthpiece/nosepiece adapters, collection filters, sample preparation unit/automation for recovery.
• Advanced Filter Holder specifics: single-piece hinged, leak-free, solvent-compatible material (same as DUSA tubes), enables in-situ rinsing and simplified filter replacement.
• Automation compatibility: Advanced Filter Holder compatible with sample preparation automation (e.g., SPU 200i) to support automated recovery processes.
• Use cases: product development, method development, comparative/bioequivalence studies and routine DDU testing under realistic usage conditions.