Benchtop assessment of sealing efficacy and breathability of additively manufactured (AM) face masks.

Addit Manuf

Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, MD 20993, USA.

Published: April 2023

The onset of the 2019 novel coronavirus disease (COVID-19) led to a shortage of personal protective equipment (PPE), medical devices, and other medical supplies causing many stakeholders and the general public alike to turn to additive manufacturing (AM) as a stopgap when normally accessible devices were not available. However, without a method to test these AM constructs, there continued to be a disconnect between AM suppliers and the community's needs. The objective of this study was to characterize the pressure drop and leakage of four different publicly available AM face mask models with two filter material combinations, as well as to investigate the impact of frame modification techniques including the use of foam strips and hot-water face forming to improve fit when the masks are donned on manikin head forms. AM face mask frame designs were downloaded from public repositories during the early stages of the COVID-19 pandemic. AM face masks were fabricated and tested on manikin head forms within a custom chamber containing dry aerosolized NaCl. Pressure drops, particle penetration, and leakage were evaluated for various flow rates and NaCl concentrations. Results indicated that filter material combination and frame modification played a major role in the overall performance of the AM face masks studied. Filter material combinations showed improved performance when high filtration fabric was used, and the cross-sectional area of the fabric was increased. AM frame modifications appeared to improve AM face mask leakage performance by as much as 69.6%.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9974208PMC
http://dx.doi.org/10.1016/j.addma.2023.103468DOI Listing

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