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A comparison of facemask and respirator filtration test methods.

ABSTRACT: NIOSH published a Federal Register Notice to explore the possibility of incorporating FDA required filtration tests for surgical masks (SMs) in the 42 CFR Part 84 respirator certification process. There have been no published studies comparing the filtration efficiency test methods used for NIOSH certification of N95 filtering facepiece respirators (N95 FFRs) with those used by the FDA for clearance of SMs. To address this issue, filtration efficiencies of "N95 FFRs" including six N95 FFR models and three surgical N95 FFR models, and three SM models were measured using the NIOSH NaCl aerosol test method, and FDA required particulate filtration efficiency (PFE) and bacterial filtration efficiency (BFE) methods, and viral filtration efficiency (VFE) method. Five samples of each model were tested using each method. Both PFE and BFE tests were done using unneutralized particles as per FDA guidance document. PFE was measured using 0.1 µm size polystyrene latex particles and BFE with ∼3.0 µm size particles containing Staphylococcus aureus bacteria. VFE was obtained using ∼3.0 µm size particles containing phiX 174 as the challenge virus and Escherichia coli as the host. Results showed that the efficiencies measured by the NIOSH NaCl method for "N95 FFRs" were from 98.15-99.68% compared to 99.74-99.99% for PFE, 99.62-99.9% for BFE, and 99.8-99.9% for VFE methods. Efficiencies by the NIOSH NaCl method were significantly (p = <0.05) lower than the other methods. SMs showed lower efficiencies (54.72-88.40%) than "N95 FFRs" measured by the NIOSH NaCl method, while PFE, BFE, and VFE methods produced no significant difference. The above results show that the NIOSH NaCl method is relatively conservative and is able to identify poorly performing filtration devices. The higher efficiencies obtained using PFE, BFE and VFE methods show that adding these supplemental particle penetration methods will not improve respirator certification.

SUBMITTER: Rengasamy S

PROVIDER: S-EPMC7157953 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:This study aims to evaluate the filtration performance of three commercially available (3M 8210 respirator, Halyard 48207 surgical mask, and 3M 1820 procedure mask) and two alternative face mask and respirator materials (Halyard H600 sterilization wrap and Cummins EX101) after selected decontamination treatments, including isopropanol (IPA) treatments (soaking or spraying), ultraviolet germicidal irradiation (UVGI), and heat treatments (dry heat at 77 °C or steam heat). Both IPA soaking and spraying removed most electrostatic charges on all four electret materials (three commercial and one alternative), causing significant deterioration of filtration efficiency to unacceptable level. The other non-electret alternative material sustained its N95-grade performance after both IPA soaking and spraying treatments, demonstrating the possible application of IPA disinfection for non-electret alternative respirator/mask materials. UVGI preserved the filtration of all three commercially available respirator/mask materials after up to 10 treatments, suggesting it can be a possible decontamination method for hospital and clinic use without compromising respirator/mask performance. The considerations of the practical implementation of this method was discussed. Between the two heat treatment methods tested, dry heat showed better compatibility with electret material by sustaining both filtration efficiency and fit (tested on commercial respirator only), although adding moisture was reported in favor of virus inactivation. Heat treatment is easily accessible method for general publics to implement at home, while it is recommended to maintain the moisture level below saturation. Comparing to size-integrated method, the size-resolved fractional efficiency measurement technique, although more time consuming, proved to be a better method for evaluating respirator/mask filtration performance after decontaminations by providing more sensitive detection of performance degradation and the capability of distinguishing charge loss to other mechanisms causing efficiency deterioration. Detailed descriptions are provided in methodology part to emphasize the cares needed for an appropriate efficiency evaluation. The limited results in this study on worn masks made of alternative sterilization wrap indicated possible performance degradation of electret material caused by normal human wearing activities, suggesting the need of assessing respirator/mask decontamination strategy by testing practically worn-and-decontaminated/reused samples instead of unworn only-decontaminated counterparts.

Project description:Improved respirator test headforms are needed to measure the fit of N95 filtering facepiece respirators (FFRs) for protection studies against viable airborne particles. A Static (i.e., non-moving, non-speaking) Advanced Headform (StAH) was developed for evaluating the fit of N95 FFRs. The StAH was developed based on the anthropometric dimensions of a digital headform reported by the National Institute for Occupational Safety and Health (NIOSH) and has a silicone polymer skin with defined local tissue thicknesses. Quantitative fit factor evaluations were performed on seven N95 FFR models of various sizes and designs. Donnings were performed with and without a pre-test leak checking method. For each method, four replicate FFR samples of each of the seven models were tested with two donnings per replicate, resulting in a total of 56 tests per donning method. Each fit factor evaluation was comprised of three 86-sec exercises: "Normal Breathing" (NB, 11.2 liters per min (lpm)), "Deep Breathing" (DB, 20.4 lpm), then NB again. A fit factor for each exercise and an overall test fit factor were obtained. Analysis of variance methods were used to identify statistical differences among fit factors (analyzed as logarithms) for different FFR models, exercises, and testing methods. For each FFR model and for each testing method, the NB and DB fit factor data were not significantly different (P > 0.05). Significant differences were seen in the overall exercise fit factor data for the two donning methods among all FFR models (pooled data) and in the overall exercise fit factor data for the two testing methods within certain models. Utilization of the leak checking method improved the rate of obtaining overall exercise fit factors ?100. The FFR models, which are expected to achieve overall fit factors ? 100 on human subjects, achieved overall exercise fit factors ? 100 on the StAH. Further research is needed to evaluate the correlation of FFRs fitted on the StAH to FFRs fitted on people. [Supplementary materials are available for this article. Go to the publisher's online edition of Journal of Occupational and Environmental Hygiene for the following free supplemental resource: a file providing detailed information on the advanced head form design and fabrication process.].

Project description:An ASTM International subcommittee on Respiratory Protection, F23.65 is currently developing a consensus standard for assessing respirator fit capability (RFC) criteria of half-facepiece air-purifying particulate respirators. The objective of this study was to evaluate if the test methods being developed for half-facepiece respirators can reasonably be applied to nonpowered full-facepiece-air-purifying respirators (FF-APR). Benchmark RFC test data were collected for three families of FF-APRs (a one-size-only family, a two-size family, and a three-size family). All respirators were equipped with P100 class particulate filters. Respirators were outfitted with a sampling probe to collect an in-mask particle concentration sample in the breathing zone of the wearer. Each of the six respirator facepieces was tested on the National Institute for Occupational Safety and Health 25-subject Bivariate Panel. The RFC test assessed face seal leakage using a PortaCount fit test. Subjects followed the corresponding Occupational Safety and Health Administration-accepted fit test protocol. Two donnings per subject/respirator model combination were performed. The panel passing rate (PPR) (number or percentage of subjects in the panel achieving acceptable fit on at least one of two donnings) was determined for each respirator family at specified fit factor passing levels of 500, 1,000, and 2,000. As a reasonable expectation based on a previous analysis of alpha and beta fit test errors for various panel sizes, the selected PPR benchmark for our study was >75%. At the fit factor passing level of 500 obtained on at least one of two donnings, the PPRs for three-, two-, and one-size families were 100, 79, and 88%, respectively. As the fit factor passing criterion increased from 500 to 1,000 or 2,000, PPRs followed a decreasing trend. Each of the three tested families of FF-APRs are capable of fitting ?75% of the intended user population at the 500 fit factor passing level obtained on at least one of two donnings. The methods presented here can be used as a reference for standards development organizations considering developing RFC test requirements.

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A comparison of facemask and respirator filtration test methods.

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