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FDA GMP Laboratory needed for FDA Nebulizer Aerosol Testing:
to FDA 784 Guidance: 27 aerosol tests (1 nebulizer model, 1 flow rate, 3 sample devices [random samples], 3 drugs [albuterol sulfate, ipratropium bromide, cromolyn sodium]), 3 tests per sample per drug [3 samples x 3 drugs x 3 tests per sample per drug = 27 tests]. Cascade impactor run at continuous 28 l/min to simulate adult conditions.
Predicate Nebulizer Testing: 9 aerosol tests (1 nebulizer model, 3 samples, 3 drugs [albuterol sulfate, ipratropium bromide, cromolyn sodium]), 1 test per sample per drug [1 model x 3 samples per model x 3 drugs = 9 tests]. Cascade impactor run at continuous 28 l/min.
Testing report to include reporting on MMAD, GSD, Total Dose, Respirable Fraction (% 1-5 microns), Respirable Dose (ug 1-5 microns), Coarse Particle Dose ( > 4.7 microns), Fine Particle Dose ( < 4.7 microns), Extra-Fine Particle Dose ( < 1.0 micron). Report to include confidence levels for performance parameters at a 95% confidence level. Statistical analysis of inter-sample variance and intra-sample variance to be included in final report. Final report in PDF format delivered by email.
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