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.

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.

Respiratory protection provided by a particulate respirator is a function of particle penetration through filter media and through faceseal leakage. Faceseal leakage largely contributes to the penetration of particles through a respirator and compromises protection. When faceseal leaks arise, filter penetration is assumed to be negligible. The contribution of filter penetration and faceseal leakage to total inward leakage (TIL) of submicron-size bioaerosols is not well studied. To address this issue, TIL values for two N95 filtering facepiece respirator (FFR) models and two surgical mask (SM) models sealed to a manikin were measured at 8 L and 40 L breathing minute volumes with different artificial leak sizes. TIL values for different size (20–800 nm, electrical mobility diameter) NaCl particles representing submicron-size bioaerosols were measured using a scanning mobility particle sizer. Efficiency of filtering devices was assessed by measuring the penetration against NaCl aerosol similar to the method used for NIOSH particulate filter certification. Results showed that the most penetrating particle size (MPPS) was ~45 nm for both N95 FFR models and one of the two SM models, and ~350 nm for the other SM model at sealed condition with no leaks as well as with different leak sizes. TIL values increased with increasing leak sizes and breathing minute volumes. Relatively, higher efficiency N95 and SM models showed lower TIL values. Filter efficiency of FFRs and SMs influenced the TIL at different flow rates and leak sizes. Overall, the data indicate that good fitting higher-efficiency FFRs may offer higher protection against submicron-size bioaerosols.

N95 particulate filtering facepiece respirators are certified by measuring penetration levels photometrically with a presumed severe case test method using charge neutralized NaCl aerosols at 85 L/min. However, penetration values obtained by photometric methods have not been compared with count-based methods using contemporary respirators composed of electrostatic filter media and challenged with both generated and ambient aerosols. To better understand the effects of key test parameters (e.g., particle charge, detection method), initial penetration levels for five N95 model filtering facepiece respirators were measured using NaCl aerosols with the aerosol challenge and test equipment employed in the NIOSH respirator certification method (photometric) and compared with an ultrafine condensation particle counter method (count based) for the same NaCl aerosols as well as for ambient room air particles. Penetrations using the NIOSH test method were several-fold less than the penetrations obtained by the ultrafine condensation particle counter for NaCl aerosols as well as for room particles indicating that penetration measurement based on particle counting offers a more difficult challenge than the photometric method, which lacks sensitivity for particles < 100 nm. All five N95 models showed the most penetrating particle size around 50 nm for room air particles with or without charge neutralization, and at 200 nm for singly charged NaCl monodisperse particles. Room air with fewer charged particles and an overwhelming number of neutral particles contributed to the most penetrating particle size in the 50 nm range, indicating that the charge state for the majority of test particles determines the MPPS. Data suggest that the NIOSH respirator certification protocol employing the photometric method may not be a more challenging aerosol test method. Filter penetrations can vary among workplaces with different particle size distributions, which suggests the need for the development of new or revised "more challenging" aerosol test methods for NIOSH certification of respirators.

Nanoparticle (<100 nm size) exposure in workplaces is a major concern because of the potential impact on human health. National Institute for Occupational Safety and Health (NIOSH)-approved particulate respirators are recommended for protection against nanoparticles based on their filtration efficiency at sealed conditions. Concerns have been raised on the lack of information for face seal leakage of nanoparticles, compromising respiratory protection in workplaces. To address this issue, filter penetration and total inward leakage (TIL) through artificial leaks were measured for NIOSH-approved N95 and P100 and European certified Conformit'e Europe'en-marked FFP2 and FFP3 filtering facepiece respirator models sealed to a breathing manikin kept inside a closed chamber. Monodisperse sucrose aerosols (8-80 nm size) generated by electrospray or polydisperse NaCl aerosols (20-1000 nm size) produced by atomization were passed into the chamber. Filter penetration and TIL were measured at 20, 30, and 40 l min(-1) breathing flow rates. The most penetrating particle size (MPPS) was ∼50 nm and filter penetrations for 50 and 100 nm size particles were markedly higher than the penetrations for 8 and 400 nm size particles. Filter penetrations increased with increasing flow rates. With artificially introduced leaks, the TIL values for all size particles increased with increasing leak sizes. With relatively smaller size leaks, the TIL measured for 50 nm size particles was ∼2-fold higher than the values for 8 and 400 nm size particles indicating that the TIL for the most penetrating particles was higher than for smaller and larger size particles. The data indicate that higher concentration of nanoparticles could occur inside the breathing zone of respirators in workplaces where nanoparticles in the MPPS range are present, when leakage is minimal compared to filter penetration. The TIL/penetration ratios obtained for 400 nm size particles were larger than the ratios obtained for 50 nm size particles at the three different flow rates and leak sizes indicating that face seal leakage, not filter penetration, contributing to the TIL for larger size particles. Further studies on face seal leakage of nanoparticles for respirator users in workplaces are needed to better understand the respiratory protection against nanoparticle exposure.