Copley Scientific has announced the launch of a new Facemask Test Stand (FMS) to facilitate delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) testing of nebulizers with face masks for Quality by Design and bioequivalence studies.
The FMS allows a nebulizer with face mask to interface securely with a standard DDU filter holder apparatus or, with the additional use of another new item called an NGI to FMS Interface Accessory, to connect more easily via the face mask to a Next Generation Impactor (NGI).
For DDU testing the FMS can be used with any of the face models sold by Copley, including the infant size; for APSD testing, the accessories can be used with either the child or adult face model. The accessories can also be used with other validated face models.
According to Copley, although testing nebulizers with a face mask in place is not part of the current pharmacopoeial method as specified in USP Chapter <1601> and Ph. Eur. 2.9.44, such testing is “advantageous both for rigorous, clinically realistic performance assessment and for product comparison (test to reference), and mirrors the approach already specified for spacer/valved holding chamber (VHC) equipped metered-dose inhalers (MDIs) in USP Chapter <1602>.
Read the Copley Scientific press release.
