Sprays, Aerosols and Inhaler testing

MALVERN SPRAYTECH

Spray and aerosol sizing

The Malvern Spraytec provides real-time particle size distribution of sprays and aerosols. This laser diffraction system is specifically designed for spray characterisation providing;

• Accurate Particle Sizing; over a dynamic range of 0.1 - 2000 microns using just two lens systems.
• Rapid Measurements: one measurement every 100 microseconds (10kHz) fully captures transient changes in both pulsed and continuous sprays.
• High Concentration : patented multiple scattering correction ensures spray measurements can be made even at high concentrations.

Spraytech with nasal spray actuator

The long optical path can be customised for different spray geometries, such as wide plumes. A range of triggering options means that measurements can be synchronised with delivery devices and spray actuators. The IP rated housing protects against dust and water and a compressed air purge prevents contamination of the optics.

Spraytech software fully controls the process from automatic alignment, background subtraction, triggering, measurement, to the final data analysis. The Size History function enables particle size trends to be easily compared and quantified. Measuring parameters can be incorporated into Standard Operating Procedures (SOPs) to ensure all users follow exactly the same methods. Full validation is provided including compliance with 21 CFR Part 11

COPELY INHALER TESTING

Cascade impactors for testing DPI and MDI

Anderson Impactors
Cascade impactors measure the aerodynamic particle size distribution from metered dose (MDI) and dry powder inhalers (DPI). The Anderson cascade impactor from Copley measures particle size in accordance with Pharmacopoeia specifications.

Anderson cascade impactor with locking clamp

The impactor has eight stages simulating the various parts of the human respiratory system. The aerosol stream passes through each stage at a constant air flow of 28.3 litre/min. Particles with the same inertia will impact upon a particular stage, whilst smaller particles will pass onto the next impaction stage. By analysing the amount of drug deposited on the various stages the fine particle dose and fraction can be calculated.

Next Generation Impactor
A group of pharmaceutical companies combined to develop a new impactor, specifically designed for pharmaceutical inhalers. The result was the Next Generation Impactor (NGI), launched in 2000.

NGI - fast easy access to collection cups

The NGI is a high performance, precision, particle classifying cascade impactor for testing MDI's and DPI's. The features are;

• Collection cups instead of stages for faster easier analysis.
• Flow range 30 to 100 litres/min
• Particle size range 0.23 to 11 microns.
• Seven stages; with five cut offs between 0.5 and 6.5 microns.
• Excellent stage efficiency, with good recovery and low internal loss.
• Unaffected by static, and corrosion resistant.

Multi stage liquid impinger
The multi stage liquid impinger (MLSI) is a five stage cascade impactor for determining the aerodynamic particle size distribution of DPI's and MDI's.

MLSI with critical flow controller

The MSLI has no interstage losses and is suitable for use throughout the range 30 to 100 litres /min. The collection stages are kept moist which helps avoid the problem of re-entrainment of powder sometimes experienced when using more conventional impactors.

Critical flow controller
The critical flow controller is installed between the vacuum pump and the test apparatus, providing a complete system for testing dry powder inhalers (DPI). The main features are;

• In-built pressure meters for measuring pressure differential and sonic flow.
• Flow control valve to adjust flow rate
• Timer to set flow duration.
• LED display of pressures and times.

Critical flow controller for DPI testing

Inhaler data analysis software
This Copley software provides a standardised approach to the recording and analysis of impactor data. MDI and DPI size distributions are reported in accordance with pharmacopoeia requirements. Features include;

• Comparison of up to 12 runs.
• Correction for calibration and flow rate changes
• Particle dose based on impactor stage or particle size.
• Shot weight report
• Calculation of fine particle dose and fraction.
• Choice of graphical presentations.
• Print out in EP and USP formats.

Software provides standardised recording

The software accepts data from all apparatus listed in pharmacopoeia, such as the Anderson cascade impactor and liquid impingers. It is supplied with full validation documentation, and details of the algorithms and methods used to calculate results.

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