Inward leakage variability between respirator fit test panels - Part II. Probabilistic approach.

This study aimed to quantify the variability between different anthropometric panels in determining the inward leakage (IL) of N95 filtering facepiece respirators (FFRs) and elastomeric half-mask respirators (EHRs). We enrolled 144 experienced and non-experienced users as subjects in this study. Each subject was assigned five randomly selected FFRs and five EHRs, and performed quantitative fit tests to measure IL. Based on the NIOSH bivariate fit test panel, we randomly sampled 10,000 pairs of anthropometric 35 and 25 member panels without replacement from the 144 study subjects. For each pair of the sampled panels, a Chi-Square test was used to test the hypothesis that the passing rates for the two panels were not different. The probability of passing the IL test for each respirator was also determined from the 20,000 panels and by using binomial calculation. We also randomly sampled 500,000 panels with replacement to estimate the coefficient of variation (CV) for inter-panel variability. For both 35 and 25 member panels, the probability that passing rates were not significantly different between two randomly sampled pairs of panels was higher than 95% for all respirators. All efficient (passing rate ≥80%) and inefficient (passing rate ≤60%) respirators yielded consistent results (probability >90%) for two randomly sampled panels. Somewhat efficient respirators (passing rate between 60% and 80%) yielded inconsistent results. The passing probabilities and error rates were found to be significantly different between the simulation and binomial calculation. The CV for the 35-member panel was 16.7%, which was slightly lower than that for the 25-member panel (19.8%). Our results suggested that IL inter-panel variability exists, but is relatively small. The variability may be affected by passing level and passing rate. Facial dimension-based fit test panel stratification was also found to have significant impact on inter-panel variability, i.e., it can reduce alpha and beta errors, and inter-panel variability.

Effect of interferents on the performance of direct-reading organic vapor monitors.

UNLABELLED: Direct-reading organic vapor monitors are often used to measure volatile organic compound concentrations in complex chemical gas mixtures. However, there is a paucity of data on the impact of multiple gases on monitor performance, even though it is known that monitor sensitivity may vary by chemical. This study investigated the effects of interferents on the performance of the MIRAN SapphIRe Portable Ambient Air Analyzer (SAP) and Century Portable Toxic Vapor Analyzer (TVA-1000) when sampling a specific agent of interest (cyclohexane). The TVA-1000 contained a dual detector: a photoionization detector (PID) and a flame ionization detector (FID). Three devices of each monitor were challenged with different combinations of cyclohexane and potential interferent vapors (hexane, methyl ethyl ketone, trichloroethylene, and toluene) at 21°C and 90% relative humidity (RH), an extreme environmental condition. Five replicates at four target concentrations were tested: 30, 150, 300, and 475 ppm. Multiple proportions of cyclohexane to interferent enabled the determination of the interferent effect on monitor performance. The monitor concentrations were compared to reference concentrations measured using NIOSH Method 1500. Three scenarios were investigated: no response factor, cyclohexane response factor, and weighted-mixed response factor applied. False negatives occurred more frequently for PID (21.1%), followed by FID (4.8%) and SAP (0.2%). Measurements from all monitors generally had a positive bias compared to the reference measurements. Some monitor measurements exceeded twice the reference concentrations: PID (36.8%), SAP (19.8%), and FID (6.3%). Evaluation of the 95% confidence intervals indicated that performance of all monitors varied by concentration. In addition, the performance of the PID and SAP varied by presence of an interfering compound, especially toluene and hexane for the PID and trichloroethylene for the SAP. Variability and bias associated with all these monitors preclude supplanting traditional sorbent-based tube methods for measuring volatile organic compounds (VOCs), especially for compliance monitoring. IMPLICATIONS: Industrial hygienists need to use care when using any of the three monitor detection types to measure the concentration of unknown chemical mixtures. Monitor performance is affected by the presence of interferents. Application of manufacturer recommended response factors may not adequately scale measurements to minimize monitor bias when compared to standard reference methods. Users should calibrate their monitors to a known reference method prior to use, if possible. Each of the monitors has its own limitations, which should be considered to ensure quality measurements are reported.

Inward Leakage Variability between Respirator Fit Test Panels - Part I. Deterministic Approach.

Inter-panel variability has never been investigated. The objective of this study was to determine the variability between different anthropometric panels used to determine the inward leakage (IL) of N95 filtering facepiece respirators (FFRs) and elastomeric half-mask respirators (EHRs). A total of 144 subjects, who were both experienced and non-experienced N95 FFR users, were recruited. Five N95 FFRs and five N95 EHRs were randomly selected from among those models tested previously in our laboratory. The PortaCount Pro+ (without N95-Companion) was used to measure IL of the ambient particles with a detectable size range of 0.02 to 1 µm. The Occupational Safety and Health Administration standard fit test exercises were used for this study. IL test were performed for each subject using each of the 10 respirators. Each respirator/subject combination was tested in duplicate, resulting in a total 20 IL tests for each subject. Three 35-member panels were randomly selected without replacement from the 144 study subjects stratified by the National Institute for Occupational Safety and Health bivariate panel cell for conducting statistical analyses. The geometric mean (GM) IL values for all 10 studied respirators were not significantly different among the three randomly selected 35-member panels. Passing rate was not significantly different among the three panels for all respirators combined or by each model. This was true for all IL pass/fail levels of 1%, 2%, and 5%. Using 26 or more subjects to pass the IL test, all three panels had consistent passing/failing results for pass/fail levels of 1% and 5%. Some disagreement was observed for the 2% pass/fail level. Inter-panel variability exists, but it is small relative to the other sources of variation in fit testing data. The concern about inter-panel variability and other types of variability can be alleviated by properly selecting: pass/fail level (IL 1-5%); panel size (e.g., 25 or 35); and minimum number of subjects required to pass (e.g., 26 of 35 or 23 of 35).

Effect of calibration environment on the performance of direct-reading organic vapor monitors.

UNLABELLED: The performance of two direct-reading organic vapor monitors (monitors) when calibrated at different environmental conditions was compared with charcoal tube results. Three MIRAN SapphIRe portable ambient air analyzers (SAP) and three Century portable toxic vapor analyzers (TVAs) were evaluated. Prior to sampling, the monitors were calibrated per the manufacturer's instructions using methane for the TVA flame ionization detector (FID) and isobutylene for the photoionization detector (PID), whereas the SapphIRe instruments were zeroed and the instrument's manufacturer-supplied library was used. For the first series of tests ("Part 1--Same condition"), the monitors were calibrated under the same environmental conditions as those present during sampling. They were then challenged with four cyclohexane concentrations (30, 150, 300, and 475 ppm) under two extreme environmental conditions: 5 degrees C and 30% relative humidity (RH) (same/cold) and 38 degrees C and 90% RH (same/hot). For the second series of tests ("Part 2--Different condition"), the monitors were calibrated at approximately normal indoor environmental conditions (21 degrees C and 50% RH) and sampled at extreme environmental conditions (different/cold and different/hot). The monitor readings from the two methods were compared with the actual cyclohexane concentration determined from charcoal tubes using ratios and root mean square errors. A number of monitor failures, both below detection limit values in the presence of a known challenge concentration and erroneously high measurements, occurred in each part: same condition 20.7% (149/720) and different condition 42.4% (305/ 720), with a majority of the failures (> 78%) during the hot and humid conditions. All monitors performed best at the same/cold, followed by the same/hot, in terms of closeness to the reference standard method and low within-monitor variability. The ranked choice of monitors for same/cold is PID > SAP > FID; for different/cold FID > PID > SAP; for same/hot SAP > PID > FID; and for different/hot PID > SAP (FID not included due to 100% failure rate). IMPLICATIONS: Direct-reading organic vapor monitors are used for assessing the concentrations of volatile organic compounds in the air at varying environmental conditions. Typical calibration is performed at laboratory temperature and pressure. The monitors may be used in atmospheres that differ from that during calibration. An understanding of the effect of calibration environment on monitor performance may provide valuable information on the reliability and appropriateness of certain monitor types for industrial hygienists, emergency responders, and exposure assessment practitioners. Results of the study indicate monitor calibration should be performed at the same environmental conditions as sampling.

Quantity and size distribution of cough-generated aerosol particles produced by influenza patients during and after illness.

The question of whether influenza is transmitted to a significant degree by aerosols remains controversial, in part, because little is known about the quantity and size of potentially infectious airborne particles produced by people with influenza. In this study, the size and amount of aerosol particles produced by nine subjects during coughing were measured while they had influenza and after they had recovered, using a laser aerosol particle spectrometer with a size range of 0.35 to 10 µm. Individuals with influenza produce a significantly greater volume of aerosol when ill compared with afterward (p = 0.0143). When the patients had influenza, their average cough aerosol volume was 38.3 picoliters (pL) of particles per cough (SD 43.7); after patients recovered, the average volume was 26.4 pL per cough (SD 45.6). The number of particles produced per cough was also higher when subjects had influenza (average 75,400 particles/cough, SD 97,300) compared with afterward (average 52,200, SD 98,600), although the difference did not reach statistical significance (p = 0.1042). The average number of particles expelled per cough varied widely from patient to patient, ranging from 900 to 302,200 particles/cough while subjects had influenza and 1100 to 308,600 particles/cough after recovery. When the subjects had influenza, an average of 63% of each subject's cough aerosol particle volume in the detection range was in the respirable size fraction (SD 22%), indicating that these particles could reach the alveolar region of the lungs if inhaled by another person. This enhancement in aerosol generation during illness may play an important role in influenza transmission and suggests that a better understanding of this phenomenon is needed to predict the production and dissemination of influenza-laden aerosols by people infected with this virus. [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 resources: a PDF file of demographic information, influenza test results, and volume and peak flow rate during each cough and a PDF file containing number and size of aerosol particles produced.].

Validation of an evacuated canister method for measuring part-per-billion levels of chemical warfare agent simulants.

The National Institute for Occupational Safety and Health (NIOSH) research on direct-reading instruments (DRIs) needed an instantaneous sampling method to provide independent confirmation of the concentrations of chemical warfare agent (CWA) simulants. It was determined that evacuated canisters would be the method of choice. There is no method specifically validated for volatile organic compounds (VOCs) in the NIOSH Manual of Analytical Methods. The purpose of this study was to validate an evacuated canister method for sampling seven specific VOCs that can be used as a simulant for CWA agents (cyclohexane) or influence the DRI measurement of CWA agents (acetone, chloroform, methylene chloride, methyl ethyl ketone, hexane, and carbon tetrachloride [CCl4]). The method used 6-L evacuated stainless-steel fused silica-lined canisters to sample the atmosphere containing VOCs. The contents of the canisters were then introduced into an autosampler/preconcentrator using a microscale purge and trap (MPT) method. The MPT method trapped and concentrated the VOCs in the air sample and removed most of the carbon dioxide and water vapor. After preconcentration, the samples were analyzed using a gas chromatograph with a mass selective detector. The method was tested, evaluated, and validated using the NIOSH recommended guidelines. The evaluation consisted of determining the optimum concentration range for the method; the sample stability over 30 days; and the accuracy, precision, and bias of the method. This method meets the NIOSH guidelines for six of the seven compounds (excluding acetone) tested in the range of 2.3-50 parts per billion (ppb), making it suitable for sampling of these VOCs at the ppb level.

Respiratory Protection in a Time of Crisis: NIOSH Testing of International Respiratory Protective Devices for Emergency Use.

National Institute for Occupational Safety and Health (NIOSH)-approved respirators are required by the Occupational Safety and Health Administration (OSHA) when personal respiratory protection is used in US occupational settings. During the COVID-19 pandemic, the demand for NIOSH-approved N95 filtering facepiece respirators overwhelmed the available supply. To supplement the national inventory of N95 respirators, contingency and crisis capacity strategies were implemented and incorporated a component that endorsed the use of non-NIOSH-approved respiratory protective devices that conformed to select international standards. The development and execution of this strategy required the collaborative effort of numerous agencies. The Food and Drug Administration temporarily authorized non-NIOSH-approved international respiratory protective devices through an emergency use authorization, OSHA relaxed their enforcement guidance concerning their use in US workplaces, and NIOSH initiated a supplemental performance assessment process to verify the quality of international devices. NIOSH testing revealed that many of the non-NIOSH-approved respiratory protective devices had filtration efficiencies below 95% and substantial inconsistencies in filtration performance. This article reports the results of the NIOSH testing to date and discusses how it has contributed to continuous improvement of the crisis strategy of temporarily permitting the use of non-NIOSH-approved respirators in US occupational settings during the COVID-19 pandemic.

Measurement capability of field portable organic vapor monitoring instruments under different experimental conditions.

The performance of field portable direct-reading organic vapor monitors (DROVMs) was evaluated under a variety of experimental conditions. Four of the DROVMs had photoionization detectors (ppbRAE, IAQRAE, MultiRAE, and Century Toxic Vapor Analyzer), one had a flame ionization detector (Century Toxic Vapor Analyzer), and one was a single-beam infrared spectrophotometer (SapphIRe). Four of each DROVM (two Century Toxic Vapor Analyzers and SapphIRes) were tested. The DROVMs were evaluated at three temperatures (4 degrees C, 21 degrees C, and 38 degrees C), three relative humidities (30%, 60%, and 90%), and two hexane concentrations (5 ppm and 100 ppm). These conditions were selected to provide a range within the operational parameters of all the instruments. At least four replicate trials were performed across the 18 experimental conditions (3 temperatures x 3 relative humidities x 2 concentrations). To evaluate performance, the 4-hr time-weighted average readings from the DROVMs in a given trial were compared with the average of two charcoal tube concentrations using pairwise comparison. The pairwise comparison criterion was +/-25% measurement agreement between each individual DROVM and the DROVMs as a group and the average charcoal tube concentration. The ppbRAE group performed the best with 40% of all readings meeting the comparison criterion followed by the SapphIRe group at 39%. Among individual DROVMs, the best performer was a SapphIRe, with 57% of its readings meeting the criterion. The data was further analyzed by temperature, humidity, and concentration. The results indicated the performance of some DROVMs may be affected by temperature, humidity, and/or concentration. The ppbRAE group performed best at 21 degrees C with the percentage of readings meeting the criterion increasing to 63%. At the 5 ppm concentration, 44% of the ppbRAE group readings met the criterion, while at 100 ppm, only 35% did. The results indicate that monitors can be used as survey tools. Based on the data, the inconsistent performance of these DROVMs may not allow them to be used for determining compliance with occupational exposure limits.

Simulated workplace protection factors for half-facepiece respiratory protective devices.

This study investigates two different methods (random effects model and 5th percentile) for determining the performance of three types of respiratory protective devices (elastomeric N95 respirators, N95 filtering-facepiece respirators, and surgical masks) during a simulated workplace test. This study recalculated the protection level of three types of respiratory protective devices using the random effects model, compared the two methods with each other and the APF of 10 for half-facepiece respirators, and determined the value of each of the fit test protocols in attaining the desired level of simulated workplace protection factor (SWPF). Twenty-five test subjects with varying face sizes tested 15 models of elastomeric N95 respirators, 15 models of N95 filtering-facepiece respirators, and 6 models of surgical masks. Simulated workplace testing was conducted using a TSI PORTACOUNT Plus model 8020 and consisted of a series of seven exercises. Six simulated workplace tests were performed with redonning of the respirator/mask occurring between each test. Each of the six tests produced an SWPF. To determine the level of protection provided by the respiratory protective devices, a 90% lower confidence limit for the simulated workplace protection factor (SWPF(LCL90%)) and the 5th percentile of simulated workplace protection factor were computed. The 5th percentile method values could be up to seven times higher than the SWPF(LCL90%) values. Without fit testing, all half-facepiece N95 respirators had a 5th percentile of 4.6 and an SWPF(LCL90%) value of 2.7. N95 filtering-facepiece respirators as a class had values of 3.3 and 2.0, respectively, whereas N95 elastomeric respirators had values of 7.3 and 4.6, respectively. Surgical masks did not provide any protection, with values of 1.2 and 1.4, respectively. Passing either the Bitrex, saccharin, or Companion fit test resulted in the respirators providing the expected level of protection with 5th percentiles greater than or equal to 10 except when passing the Bitrex test with N95 filtering-facepiece respirators, which resulted in a 5th percentile of only 7.9. No substantial difference was seen between the three fit tests. All of the SWPF(LCL90%) values after passing a fit test were less than 10. The random model method provides a more conservative estimate of the protection provided by a respirator because it takes into account both between- and within-wearer variability.

Comparison of performance of three different types of respiratory protection devices.

Respiratory protection is offered to American workers in a variety of ways to guard against potential inhalation hazards. Two of the most common ways are elastomeric N95 respirators and N95 filtering-facepiece respirators. Some in the health care industry feel that surgical masks provide an acceptable level of protection in certain situations against particular hazards. This study compared the performance of these types of respiratory protection during a simulated workplace test that measured both filter penetration and face-seal leakage. A panel of 25 test subjects with varying face sizes tested 15 models of elastomeric N95 respirators, 15 models of N95 filtering-facepiece respirators, and 6 models of surgical masks. Simulated workplace testing was conducted using a TSI PORTACOUNT Plus model 8020, and consisted of a series of seven exercises. Six simulated workplace tests were performed with redonning of the respirator/mask occurring between each test. The results of these tests produced a simulated workplace protection factor (SWPF). The geometric mean (GM) and the 5th percentile values of the SWPFs were computed by category of respiratory protection using the six overall SWPF values. The level of protection provided by each of the three respiratory protection types was compared. The GM and 5th percentile SWPF values without fit testing were used for the comparison, as surgical masks were not intended to be fit tested. The GM values were 36 for elastomeric N95 respirators, 21 for N95 filtering-facepiece respirators, and 3 for surgical masks. An analysis of variance demonstrated a statistically significant difference between all three. Elastomeric N95 respirators had the highest 5th percentile SWPF of 7. N95 filtering-facepiece respirators and surgical masks had 5th percentile SWPFs of 3 and 1, respectively. A Fisher Exact Test revealed that the 5th percentile SWPFs for all three types of respiratory protection were statistically different. In addition, both qualitative (Bitrex and saccharin) and quantitative (N95-Companion) fit testing were performed on the N95 filtering- and elastomeric-facepiece respirators. It was found that passing a fit test generally improves the protection afforded the wearer. Passing the Bitrex fit test resulted in 5th percentile SWPFs of 11.1 and 7.9 for elastomeric and filtering-facepiece respirators, respectively. After passing the saccharin tests, the elastomeric respirators provided a 5th percentile of 11.7, and the filtering-facepiece respirators provided a 5th percentile of 11.0. The 5th percentiles after passing the N95-Companion were 13.0 for the elastomeric respirators and 20.5 for the filtering-facepiece respirators. The data supports fit testing as an essential element of a complete respiratory protection program.

Errors associated with three methods of assessing respirator fit.

Three fit test methods (Bitrex, saccharin, and TSI PortaCount Plus with the N95-Companion) were evaluated for their ability to identify wearers of respirators that do not provide adequate protection during a simulated workplace test. Thirty models of NIOSH-certified N95 half-facepiece respirators (15 filtering-facepiece models and 15 elastomeric models) were tested by a panel of 25 subjects using each of the three fit testing methods. Fit testing results were compared to 5th percentiles of simulated workplace protection factors. Alpha errors (the chance of failing a fit test in error) for all 30 respirators were 71% for the Bitrex method, 68% for the saccharin method, and 40% for the Companion method. Beta errors (the chance of passing a fit test in error) for all 30 respirator models combined were 8% for the Bitrex method, 8% for the saccharin method, and 9% for the Companion method. The three fit test methods had different error rates when assessed with filtering facepieces and when assessed with elastomeric respirators. For example, beta errors for the three fit test methods assessed with the 15 filtering facepiece respirators were < or = 5% but ranged from 14% to 21% when assessed with the 15 elastomeric respirators. To predict what happens in a realistic fit testing program, the data were also used to estimate the alpha and beta errors for a simulated respiratory protection program in which a wearer is given up to three trials with one respirator model to pass a fit test before moving onto another model. A subject passing with any of the three methods was considered to have passed the fit test program. The alpha and beta errors for the fit testing in this simulated respiratory protection program were 29% and 19%, respectively. Thus, it is estimated, under the conditions of the simulation, that roughly one in three respirator wearers receiving the expected reduction in exposure (with a particular model) will fail to pass (with that particular model), and that roughly one in five wearers receiving less reduction in exposure than expected will pass the fit testing program in error.

The effect of subject characteristics and respirator features on respirator fit.

A recent study was conducted to compare five fit test methods for screening out poor-fitting N95 filtering-facepiece respirators. Eighteen models of NIOSH-certified, N95 filtering-facepiece respirators were used to assess the fit test methods by using a simulated workplace protection factor (SWPF) test. The purpose of this companion study was to investigate the effect of subject characteristics (gender and face dimensions) and respirator features on respirator fit. The respirator features studied were design style (folding and cup style) and number of sizes available (one size fits all, two sizes, and three sizes). Thirty-three subjects participated in this study. Each was measured for 12 face dimensions using traditional calipers and tape. From this group, 25 subjects with face size categories 1 to 10 tested each respirator. The SWPF test protocol entailed using the PortaCount Plus to determine a SWPF based on total penetration (face-seal leakage plus filter penetration) while the subject performed six simulated workplace movements. Six tests were conducted for each subject/respirator model combination with redonning between tests. The respirator design style (folding style and cup style) did not have a significant effect on respirator fit in this study. The number of respirator sizes available for a model had significant impact on respirator fit on the panel for cup-style respirators with one and two sizes available. There was no significant difference in the geometric mean fit factor between male and female subjects for 16 of the 18 respirator models. Subsets of one to six face dimensions were found to be significantly correlated with SWPFs (p < 0.05) in 16 of the 33 respirator model/respirator size combinations. Bigonial breadth, face width, face length, and nose protrusion appeared the most in subsets (five or six) of face dimensions and their multiple linear regression coefficients were significantly different from zero (p < 0.05). Lip length was found in only one subset. The use of face length and lip length as the criteria to define the current half-facepiece respirator fit test panel may need to be reconsidered when revising the panel. Based on the findings from this and previous studies, face length and face width are recommended measurements that should be used for defining the panel for half-facepiece respirators.

Fitting characteristics of eighteen N95 filtering-facepiece respirators.

Four performance measures were used to evaluate the fitting characteristics of 18 models of N95 filtering-facepiece respirators: (1) the 5th percentile simulated workplace protection factor (SWPF) value, (2) the shift average SWPF value, (3) the h-value, and (4) the assignment error. The effect of fit-testing on the level of protection provided by the respirators was also evaluated. The respirators were tested on a panel of 25 subjects with various face sizes. Simulated workplace protection factor values, determined from six total penetration (face-seal leakage plus filter penetration) tests with re-donning between each test, were used to indicate respirator performance. Five fit-tests were used: Bitrex, saccharin, generated aerosol corrected for filter penetration, PortaCount Plus corrected for filter penetration, and the PortaCount Plus with the N95-Companion accessory. Without fit-testing, the 5th percentile SWPF for all models combined was 2.9 with individual model values ranging from 1.3 to 48.0. Passing a fit-test generally resulted in an increase in protection. In addition, the h-value of each respirator was computed. The h-value has been determined to be the population fraction of individuals who will obtain an adequate level of protection (i.e., SWPF >/=10, which is the expected level of protection for half-facepiece respirators) when a respirator is selected and donned (including a user seal check) in accordance with the manufacturer's instructions without fit-testing. The h-value for all models combined was 0.74 (i.e., 74% of all donnings resulted in an adequate level of protection), with individual model h-values ranging from 0.31 to 0.99. Only three models had h-values above 0.95. Higher SWPF values were achieved by excluding SWPF values determined for test subject/respirator combinations that failed a fit-test. The improvement was greatest for respirator models with lower h-values. Using the concepts of shift average and assignment error to measure respirator performance yielded similar results. The highest level of protection was provided by passing a fit-test with a respirator having good fitting characteristics.

Comparison of five methods for fit-testing N95 filtering-facepiece respirators.

Five fit-testing methods (Bitrex, ambient aerosol condensation nuclei counter using the TSI PortaCount Plus, saccharin, modified ambient aerosol condensation nuclei counter using the TSI PortaCount Plus with the N95-Companion, and generated aerosol using corn oil) were evaluated for their ability to identify poorly fitting N95 filtering-facepiece respirators. Eighteen models of NIOSH-certified, N95 filtering-facepiece respirators were tested by a panel of 25 subjects using each fit-testing method. The penetration of the corn oil and the ambient aerosols through the filter media of each respirator was measured in order to adjust the corresponding generated and ambient aerosol overall fit factors, reflecting only face-seal leakage. Fit-testing results were compared to 5th percentiles of simulated workplace protection factors. Beta errors (the chance of passing a fit-test in error) ranged from 3 percent to 11 percent. Alpha errors (the chance of failing a fit-test in error) ranged from 51 percent to 84 percent. The ambient aerosol using the TSI PortaCount Plus and the generated aerosol methods identified poorly fitting respirators better than the saccharin, the Companion, and Bitrex methods. These errors rates should be considered when selecting a fit-testing method for fitting N95 filtering-facepieces. When both types of errors were combined as an assignment error, the ambient aerosol method using the TSI PortaCount Plus had the lowest percentage of wearers being assigned a poor-fitting respirator.

Correlation between quantitative fit factors and workplace protection factors measured in actual workplace environments at a steel foundry.

Past studies have found little or no correlation between workplace protection factors (WPFs) and quantitative fit factors (FFs). This study investigated the effect of good- and poor-fitting half-facepiece, air-purifying respirators on protection in actual workplace environments at a steel foundry and the correlation between WPFs and FFs. Fifteen burners and welders, who wore respirators voluntarily, and chippers participated in this study. Each subject was fit-tested with two respirator models each with three sizes, for a total of six fit-tests. Models and sizes were assigned this way to provide a wide range of FFs among study participants. Each worker donned the respirator twice per day (at the beginning of the shift and following the lunch break) for 2 days. Quantitative FFs were first obtained for each donning using the PortaCount Plus trade mark in a separate room. Without redonning the respirators, workers performed normal work for 1 to 2 hours, and WPFs were measured by collecting ambient and in-facepiece samples simultaneously. A second fit-test was conducted without disturbing the respirator. FFs were obtained by averaging the results from the first and second fit-tests. The resulting FFs had a geometric mean (GM) of 400 (range=10-6010) and a geometric standard deviation (GSD) of 6.1. Of the 55 valid donnings, 43 were good fitting (FFs> or =100) and 12 were poor fitting (FFs<100). The WPFs had a GM of 920 (range=13-230,000) and a GSD of 17.8. The WPFs were found to be significantly correlated with the FFs (R(2)=.55 and p-value=.0001). Therefore, FF was shown to be a meaningful indicator of respirator performance in actual workplace environments.