59
Performance
Table 9. 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 10ºC (18ºF) above ambient
during normal use.
Table 10 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 10. 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
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