Copley Scientific has released the NGI Cooler, a practical, easy to use system that improves the accuracy and reproducibility of inhaler product testing for solution-based devices such as nebulisers.
New pharmacopoeia monographs for nebuliser testing recommend using the Next Generation Pharmaceutical Impactor (NGI) for droplet-size analysis.
They also highlight the issue of evaporative loss, which may result in artificially low particle-size measurements.
The new system's rapid cooling-action and ability to maintain stable temperatures throughout the test help avoid this problem.
Copley Scientific will display its systems for inhaled product testing at RDD Europe (19-22 May 2009, Lisbon, Portugal).
Cascade impaction measures aerodynamic particle or droplet size, a key parameter for all inhaled products.
It ensures product consistency and broadly indicates deposition behaviour within the respiratory system.
For devices such as nebulisers - which deliver the active ingredient as an aerosolised solution - evaporation during testing, caused by impactor-related heat transfer, is an issue.
Loss of solvent reduces droplet size, producing artificially low particle-size measurements and compromising accurate characterisation of the device.
Cooling the impactor to approximately 5C is one of the most common ways around this problem.
The NGI cooler comfortably accommodates the NGI, either closed or open, allowing testing in a temperature-controlled environment.
Rapid cooling ensures that test temperatures, user adjustable to as low as 3C, are reached in less than five minutes; temperature stability is to within +/-1.5C.
Large front and rear opening doors allow for easy access, with special access ports for the externally mounted device and pump tubing.
