Aerogen Solo - Performance Characteristics

Aerogen
®
Solo System Instruction Manual
29
Performance
Table 6. Performance Specifications of the Aerogen Solo
FlowRate > 0.2 mL/min (Average ~ 0.38 mL/min)
Particle Size
As measured with the Andersen Cascade Impactor:
Specification Range: 1-5 μm
Average Tested: 3.1 μm
As per EN 13544-1:
Aerosol Output rate: 0.30 mL/min
Aerosol Output: 1.02 mL emitted of 2.0 mL dose
Residual Volume: <0.1 mL for 3 mL dose
Performance may vary depending upon the type of drug and nebulizer used. For
additional information contact Aerogen or drug supplier.
Thetemperatureofthemedicationwillnotrisemorethan10°C(18°F)aboveambient
during normal use.
Table 7 shows the results of aerosol performance testing for the Aerogen
Solo using an 8 stage cascade impactor running at a continuous flow rate
of 28.3 LPM. Indicated ranges correspond to confidence intervals with a
confidence level of 95%.
Table 7. Aerogen Solo Aerosol Performance Testing
Albuterol Sulphate
(1mg/ml)
Ipratropium
(0.25mg/ml)
Budesonide
(0.5mg/ml)
Particle size (μm) 2.90 - 3.23 3.07 - 3.42 3.45 - 3.79
Geometric Standard
Deviation (GSD)
2.09 - 2.35 1.80 - 1.93 1.92 - 2.14
Emitted Dose
(% of fill)
97.23 - 99.30 97.61 - 98.64 94.12 - 97.84
Respirable Dose
(0.5 – 5.0 μm)
(% of fill)
67.66 - 73.50 71.78 - 76.69 62.32 - 66.90
Coarse particle Dose
(>4.7 μm)
(% of fill)
27.00 - 31.11 23.62 - 28.21 32.31 - 36.12