Ensuring the Consistency of Performance of Mesh Nebulizers

R. H M Hatley, L. E A Hardaker, A. P Metcalf, J. Parker, F. Quadrelli & J. N Pritchard
Poster

The consistency in aerosol performance of the mesh in a mesh nebulizer is important as variability can affect the respirable delivered dose and treatment time. In addition meshes should be replaced periodically as part of routine mesh nebulizer maintenance, here it is particularly important that the output rate and thus treatment time of the new mesh should be similar to the one it replaced as differences could be perceived by the patient as a less effective treatment if there is variability in treatment time. We tested the consistency of performance of 73 randomly selected InnoSpire Go meshes from 7 batches manufactured using new in-process controls intended to minimize variability in aerosol performance. The mesh was placed in an Aerogen fixture and attached through a connector to a Spraytec laser diffraction system (set to 6 L/min extraction with an additional 7 L/min sheath air). Data acquisition was started on the Spraytec and the generator was started. Two priming runs were performed by transferring 50 μL of 0.9% saline to the fixture then tests were performed in triplicate with 250 μL of 0.9% saline. This method was repeated for each of the 73 meshes. Volume median diameter (VMD) and output rate were comparable between the batches; mean VMD was 4.76 μm with a range of ±0.2 μm around the mean, and mean output rate was 0.55 mL/min with a range of 0.03 mL/min below and 0.01 mL/min above the mean. The maximum difference between the batches for VMD was 0.4 μm and for output rate was 0.04 mL/min. VMD and output rate were consistent between the batches of meshes tested; therefore, replacement of the mesh should not cause variation in treatment time or particle size.

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