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.

The National Institute for Occupational Safety and Health (NIOSH) and European Norms (ENs) employ different test protocols for evaluation of air-purifying particulate respirators commonly referred to as filtering facepiece respirators (FFR). The relative performance of the NIOSH-approved and EN-certified 'Conformité Européen' (CE)-marked FFR is not well studied. NIOSH requires a minimum of 95 and 99.97% efficiencies for N95 and P100 FFR, respectively; meanwhile, the EN requires 94 and 99% efficiencies for FFRs, class P2 (FFP2) and class P3 (FFP3), respectively. To better understand the filtration performance of NIOSH- and CE-marked FFRs, initial penetration levels of N95, P100, FFP2 and FFP3 respirators were measured using a series of polydisperse and monodisperse aerosol test methods and compared. Initial penetration levels of polydisperse NaCl aerosols [mass median diameter (MMD) of 238 nm] were measured using a method similar to the NIOSH respirator certification test method. Monodisperse aerosol penetrations were measured using silver particles for 4-30 nm and NaCl particles for 20-400 nm ranges. Two models for each FFR type were selected and five samples from each model were tested against charge neutralized aerosol particles at 85 l min(-1) flow rate. Penetrations from the 238 nm MMD polydisperse aerosol test were <1% for N95 and FFP2 models and <0.03% for P100 and FFP3 models. Monodisperse aerosol penetration levels showed that the most penetrating particle size (MPPS) was in the 30-60 nm range for all models of FFRs tested in the study. Percentage penetrations at the MPPS were <4.28, <2.22, <0.009 and <0.164 for the N95, FFP2, P100 and FFP3 respirator models, respectively. The MPPS obtained for all four FFR types suggested particle capturing by electrostatic mechanism. Liquid isopropanol treatment of FFRs shifted the MPPS to 200-300 nm and dramatically increased polydisperse as well as monodisperse aerosol penetrations of all four FFR types indicating that all the four FFR types share filtration characteristics of electret filters. Electrostatic charge removal from all four FFR types also increased penetration levels of 400-1000 nm range particles. Particle penetration data obtained in this study showed that the eight models of NIOSH-approved N95 and P100 and CE-marked FFP2 and FFP3 respirators used in this study provided expected levels of laboratory filtration performance against nanoparticles.

A chamber to apply aerosolized virus-containing particles to air-permeable substrates (coupons) was constructed and validated as part of a method to assess the virucidal efficacy of decontamination procedures for filtering facepiece respirators. Coliphage MS2 was used as a surrogate for pathogenic viruses for confirmation of the efficacy of the bioaerosol respirator test system. The distribution of virus applied onto and within the coupons was characterized, and the repeatability of applying a targeted virus load was examined. The average viable virus loaded onto 90 coupons over the course of 5 days was found to be 5.09 ؎ 0.19 log 10 PFU/coupon (relative standard deviation, 4%). To determine the ability to differentiate the effectiveness of disinfecting procedures with different levels of performance, sodium hypochlorite and steam treatments were tested in experiments by varying the dose and time, respectively. The role of protective factors was assessed by aerosolizing the virus with various concentrations of the aerosol-generating medium. A sodium hypochlorite (bleach) concentration of 0.6% and steam treatments of 45 s and longer resulted in log reductions (>4 logs) which reached the detection limits for both levels of protective factors. Organic matter (ATCC medium 271) as a protective factor afforded some protection to the virus in the sodium hypochlorite experiments but was not a factor in the steam experiments. The evaluation of the bioaerosol respirator test system demonstrated a repeatable method for applying a targeted viral load onto respirator coupons and provided insight into the properties of aerosols that are of importance to the development of disinfection assays for air-permeable materials.

The aim of this study was to develop a test system to evaluate the effectiveness of procedures for decontamination of respirators contaminated with viral droplets. MS2 coliphage was used as a surrogate for pathogenic viruses. A viral droplet test system was constructed, and the size distribution of viral droplets loaded directly onto respirators was characterized using an aerodynamic particle sizer. The sizes ranged from 0.5 to 15 m, and the sizes of the majority of the droplets were the range from 0.74 to 3.5 m. The results also showed that the droplet test system generated similar droplet concentrations (particle counts) at different respirator locations. The test system was validated by studying the relative efficiencies of decontamination of sodium hypochlorite (bleach) and UV irradiation with droplets containing MS2 virus on filtering facepiece respirators.

This study investigated the filtration performance of NIOSH-approved N95 and P100 filtering facepiece respirators (FFR) against six different monodisperse silver aerosol particles in the range of 4-30 nm diameter. A particle test system was developed and standardized for measuring the penetration of monodisperse silver particles. For respirator testing, five models of N95 and two models of P100 filtering facepiece respirators were challenged with monodisperse silver aerosol particles of 4, 8, 12, 16, 20, and 30 nm at 85 L/min flow rate and percentage penetrations were measured. Consistent with single-fiber filtration theory, N95 and P100 respirators challenged with silver monodisperse particles showed a decrease in percentage penetration with a decrease in particle diameter down to 4 nm. Penetrations less than 1 particle/30 min for 4-8 nm particles for one P100 respirator model, and 4-12 nm particles for the other P100 model, were observed. Experiments were also carried out with larger than 20 nm monodisperse NaCl particles using a TSI 3160 Fractional Efficiency Tester. NaCl aerosol penetration levels of 20 nm and 30 nm (overlapping sizes) particles were compared with silver aerosols of the same sizes by a three-way ANOVA analysis. A significant (p < 0.001) difference between NaCl and silver aerosol penetration levels was obtained after adjusting for particle sizes and manufacturers. A significant (p = 0.001) interaction with manufacturers indicated the difference in NaCl, and silver aerosol penetrations were not the same across manufacturers. The two aerosols had the same effect across 20 nm and 30 nm sizes as shown by the absence of any significant (p = 0.163) interaction with particle sizes. In the case of P100 FFRs, a significant (p < 0.001) difference between NaCl and silver aerosol (20 nm and 30 nm) penetrations was observed for both respirator models tested. The filtration data for 4-30 nm monodisperse particles supports previous studies that indicate NIOSH-approved air-purifying respirators provide expected levels of filtration protection against nanoparticles.