Cascade Impactor (CI) Mensuration—An Assessment of the Accuracy and Precision of Commercially Available Optical Measurement Systems |
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Authors: | Frank Chambers Aziz Ali Jolyon Mitchell Christopher Shelton Steve Nichols |
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Institution: | (1) AstraZeneca Charnwood, Loughborough, UK;(2) Trudell Medical International, London, Canada;(3) PPD Inc., 8551 Research Way, Suite 90, Middleton, Wisconsin 53562-4664, USA;(4) OINDP Consultant, Cheshire, UK; |
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Abstract: | Multi-stage cascade impactors (CIs) are the preferred measurement technique for characterizing the aerodynamic particle size
distribution of an inhalable aerosol. Stage mensuration is the recommended pharmacopeial method for monitoring CI “fitness
for purpose” within a GxP environment. The Impactor Sub-Team of the European Pharmaceutical Aerosol Group has undertaken an
inter-laboratory study to assess both the precision and accuracy of a range of makes and models of instruments currently used
for optical inspection of impactor stages. Measurement of two Andersen 8-stage ‘non-viable’ cascade impactor “reference” stages
that were representative of jet sizes for this instrument type (stages 2 and 7) confirmed that all instruments evaluated were
capable of reproducible jet measurement, with the overall capability being within the current pharmacopeial stage specifications
for both stages. In the assessment of absolute accuracy, small, but consistent differences (ca. 0.6% of the certified value)
observed between ‘dots’ and ‘spots’ of a calibrated chromium-plated reticule were observed, most likely the result of treatment
of partially lit pixels along the circumference of this calibration standard. Measurements of three certified ring gauges,
the smallest having a nominal diameter of 1.0 mm, were consistent with the observation where treatment of partially illuminated
pixels at the periphery of the projected image can result in undersizing. However, the bias was less than 1% of the certified
diameter. The optical inspection instruments evaluated are fully capable of confirming cascade impactor suitability in accordance
with pharmacopeial practice. |
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