Next Generation Pharmaceutical Impactor (a new impactor for pharmaceutical inhaler testing). Part II: Archival calibration

Virgil A. Marple, Bernard A. Olson, Kumaragovindham Santhanakrishnan, Jolyon P. Mitchell, Sharon C. Murray, Buffy L. Hudson-Curtis

Research output: Contribution to journalArticlepeer-review

98 Scopus citations

Abstract

A new seven-stage cascade impactor, the Next Generation Pharmaceutical Impactor (NGI), has been developed for the pharmaceutical industry. A calibration following "good laboratory practice (GLP)" procedures has been performed on a specific archival NGI, deemed to be representative of all NGIs. Thus, this impactor had nozzle dimensions for each stage manufactured close to the middle of the tolerance band for the design specification, and therefore the average nozzle diameter was equal to the nominal value for that stage. An essential feature of the NGI is that it is designed to operate at any flow rate between 30 and 100 L/min. Thus, the calibration was made at inlet flow rates of 30, 60 and 100 L/min representing the lower bound, mid-region and upper bound of the specified range of operation for the impactor. The calibration data were then used to develop equations that predict the particle cut size for all components of the impactor at any flow rate from 30 to 100 L/min.

Original languageEnglish (US)
Pages (from-to)301-324
Number of pages24
JournalJournal of Aerosol Medicine: Deposition, Clearance, and Effects in the Lung
Volume16
Issue number3
DOIs
StatePublished - Oct 6 2003

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