Aerogen USB Controller - Aerogen Pro Performance

60
Aerogen
®
Table 10. Aerogen Solo Aerosol Performance Testing (Continued)
Albuterol Sulphate
(1mg/ml)
Ipratropium
(0.25mg/ml)
Budesonide
(0.5mg/ml)
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
Note: The results provided are for n=3 devices tested in triplicate for each
drug.
The results provided for the Aerogen
®
Solo nebulizer are reflective
of the Aerogen
®
Pro nebulizer, as the fundamental scientific
technology in both nebulizers is the same.
Table 11. Performance Specifications of the Aerogen Pro
Flow Rate >0.2 mL/min (Average: ≈ 0.4 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, with a starting dose of 2 mL:
• Aerosol Output rate: 0.24 mL/min
• Aerosol Output: 1.08 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 unit used. For
additional information contact Aerogen or drug supplier.
The temperature of the medication will not rise more than 10ºC (18ºF) above ambient
temperature during normal use.