26
Aerogen
Performance
Table 7.
Performance Specifications of the Aeroneb 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 8 shows the results of aerosol performance testing for the Aeroneb 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 8.
Aeroneb Solo Aerosol Performance Testing
Albuterol Sulphate
(1mg/ml)
Budesonide
(0.5mg/ml)
Ipratropium
(0.25mg/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
Fine particle Dose
(<4.7 μm)
(% of fill)
66.33 - 72.07
68.58 - 73.84
59.36 - 64.17
Ultra-fine Particle
Dose (<1.0 μm)
(% of fill)
5.91 - 9.93
1.85 - 4.19
2.36 - 4.51
