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.     

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.     

Capability of respirator wearers to detect aerosolized qualitative fit test agents (sweetener and Bitrex) with known fixed leaks

This study was designed to evaluate and compare the ability of respirator wearers to detect qualitative respirator fit test agents (saccharin and Bitrex) when the respirators were modified to include fixed size leaks. In recent years the number of persons who require fit testing has increased, partly in response to the needs of health care workers with potential exposure to infectious bio-aerosols. Many health care providers have chosen qualitative respirator fit testing using saccharin and/or Bitrex for a variety of reasons, including (but not limited to) low initial equipment cost. Respirators were modified to include a mid-line sampling probe between the nose and mouth for quantitative fit testing with a TSI PortaCount. A second modification included the introduction of a shortened 14-gauge intravenous catheter at the bridge of the nose. The fixed leak was designed to produce fit factors < 100 when unplugged, with an average fit factor of 67 among 26 respirator wearers. A complete fit test was not performed, because one purpose of this study was to determine the ability of respirator wearers to detect a known fixed leak during a single normal breathing exercise, without introducing unknown and potentially variable size leaks. Sensitivity threshold screening included a placebo and requirement to correctly characterize the taste of the agent used. Quantitative fit factors without leaks ranged from 96 to > 20,000 and 22 to 160 with the leak present. Twenty four of 26 subjects had fit factors < 100 (92%) when fixed leaks were induced. All subjects correctly detected Bitrex with fixed leaks (sensitivity = 100%). Nine of 26 subjects (35%) were unable to detect saccharin in the presence of a known fixed leak even though the average fit factor for these subjects was 77. When the two subjects with fit factors > 100 were excluded, only 16 of 24 respirator wearers were able to detect saccharin with fixed leaks (sensitivity = 67%). There were several important aspects of our study design worth noting, including the introduction of a placebo during sensitivity threshold testing, limiting the subject response time to a single maneuver, using a higher concentration of Bitrex than commercially available, and requiring the subjects to correctly characterize the taste of the qualitative test agent. In conclusion, leak detection was correctly identified with Bitrex, but not saccharin.     

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.     

Respiratory protection against Mycobacterium tuberculosis: quantitative fit test outcomes for five type N95 filtering-facepiece respirators

In preparing to fit test a large workforce, a respirator program manager needs to initially choose respirators that will fit the greatest proportion of employees and achieve the best fits. This article discusses our strategy in selecting respirators from an initial array of seven NIOSH-certified Type N95 filtering-facepiece devices for a respiratory protection program against Mycobacterium tuberculosis (M. tb) aerosol. The seven respirators were screened based on manufacturer-provided fit test data, comfort, and cost. From these 7 devices, 5 were chosen for quantitative fit testing on 40 subjects who were a convenience sample from a cohort of approximately 30,000 workers scheduled to undergo fit testing. Across the five brands, medium/regular-size respirators fit from 8% to 95% of the subjects; providing another size of the same brand improved the pass rates slightly. Gender was not found to significantly affect fit test pass rates for any respirator brand. Among test panel members, an Aearo Corporation respirator (TC 84A-2630) and a 3M Company respirator (TC 84A-0006) provided the highest overall pass rates of 98% and 90%, respectively. We selected these two brands for fit testing in the larger worker cohort. To date, these two respirators have provided overall pass rates of 98% (1793/1830) and 88% (50/57), respectively, which are similar to the test panel results. Among 1850 individuals who have been fit tested, 1843 (99.6%) have been successfully fitted with one or the other brand. In a separate analysis, we used the test panel pass rates to estimate the reduction in M. tb infection risk afforded by the medium/regular-size of five filtering-facepiece respirators. We posed a low-exposure versus a high-exposure scenario for health care workers and assumed that respirators could be assigned without conducting fit testing, as proposed by many hospital infection control practitioners. Among those who would pass versus fail the fit test, we assumed an average respirator penetration (primarily due to faceseal leakage) of .04 and 0.3, respectively. The respirator with the highest overall pass rate (95%) reduced M. tb infection risk by 95%, while the respirator with the lowest pass rate (8%) reduced M. tb infection risk by only 70%. To promote the marketing of respirators that will successfully fit the highest proportion of wearers, and to increase protection for workers who might use respirators without the benefit of being fit tested, we recommend that fit testing be part of the NIOSH certification process for negative-pressure air-purifying respirators with tightly fitting facepieces. At a minimum, we recommend that respirator manufacturers generate and provide pass rate data to assist in selecting candidate respirators. In any event, program managers can initially select candidate respirators by comparing quantitative fit tests for a representative sample of their employee population.     

Qualitative fitting characteristics of elastomeric half face-piece respirators using Isoamyl acetate agent

To examine the fit testing of elastomeric half face-piece respirators (EHRs), a total of 41 candidates were randomly assigned into seven EHRs equipped with organic vapor (OV) cartridges which were commonly used in the Iranian industrial workplaces. The qualitative fitting into the facial dimensions was assessed using the Allegro Isoamyl Acetate fit test kit. While the studied EHRs showed very low passing fit testing rates, the 3M, AoSafety (Medium), and AoSafety (Large) had the highest passing rates with 22.0%, 14.60%, and 9.76%, respectively. The AoSafety (All sizes) delivered a higher passing fit test rate than the 3M brand (29.30 vs. 22.0%). The one size fits all respirators including the DUO and Climax showed lower proportions of passing fit tests compared with AoSafety three-size system brands (2.40% and 4.90% vs. 29.30%). Low fit test passing rates were determined among different respirators. The respirators with various sizes and styles had more opportunities for different wearers to pass the fit test than single size models. The initial and annual fit testing requirements shall be developed by local government. Also, the manufacturers are required to pay attention to respirator features and subject characteristics during the production to obtain satisfactory protection for the end-users.     

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.     

Simulated workplace performance of N95 respirators.

During July 1995 the National Institute for Occupational Safety and Health (NIOSH) began to certify nine new classes of particulate respirators. To determine the level of performance of these respirators, NIOSH researchers conducted a study to (1) measure the simulated workplace performance of 21 N95 respirator models, (2) determine whether fit-testing affected the performance, and (3) investigate the effect of varying fit-test pass/fail criteria on respirator performance. The performance of each respirator model was measured by conducting 100 total penetration tests. The performance of each respirator model was then estimated by determining the 95th percentile of the total penetration through the respirator (i.e., 95% of wearers of that respirator can expect to have a total penetration value below the 95th percentile penetration value). The 95th percentile of total penetrations for each respirator without fit-testing ranged from 6 to 88%. The 95th percentile of total penetrations for all the respirators combined was 33%, which exceeds the amount of total penetration (10%) normally expected of a half-mask respirator. When a surrogate fit test (1% criterion) was applied to the data, the 95th percentile of total penetrations for each respirator decreased to 1 to 16%. The 95th percentile of total penetrations for all the respirators combined was only 4%. Therefore, fit-testing of N95 respirators is necessary to ensure that the user receives the expected level of protection. The study also found that respirator performance was dependent on the value of the pass/fail criterion used in the surrogate fit-test.     

Reducing respirator fit test errors: a multi-donning approach

As a continuation of recent studies to assess the accuracy of existing fit test methods, a multi-donning approach to fit testing is presented. As an example of that approach, a multi-donning quantitative fit test for filtering-facepiece respirators is presented and analyzed by comparing its error rates with those of the single-donning approach of current fit test methods. That analysis indicates the multi-donning fit test has the potential to reduce both the alpha error and the beta error to half that of single-donning fit tests. The alpha error is the error of failing a respirator that should pass; the beta error is the error of passing a respirator that should fail. Lowering fit test error rates for filtering-facepiece respirators is important because fit testing is an essential means of helping assure that an individual has selected an adequately fitting respirator. To reduce the alpha and beta error inherent in current fit test methods, the proposed fit test for filtering-facepiece respirators incorporates five donnings of the facepiece, unlike the single donning of existing fit test methods. The analysis presented here indicates that the multiple-donning approach reduces the element of chance in the fit test result and thereby increases the consistency and accuracy of the fit tests. The time to conduct the multi-donning test can approximate the time for current, single-donning tests by shortening the time the respirator is worn after each donning to about 10 sec. And, unlike current fit tests for filtering-facepieces that measure only faceseal leakage, the example multiple-donning fit test considered here is based on a measurement of total leakage (faceseal plus filter). Utilizing total respirator leakage can result in simpler quantitative fit test instrumentation and a fit test that is more relevant to the workplace. Further trials with human subjects are recommended in order to validate the proposed multi-donning approach.     

Determination of known exhalation valve damage using a negative pressure user seal check method on full facepiece respirators

A negative pressure user seal check (NPUSC) method was evaluated for its ability to adequately detect known exhalation valve leakage into a respirator. Three valves with different types of damage were included. Twenty-six test subjects, wearing full facepiece respirators, were asked to perform a NPUSC. Their responses as to whether they passed or failed the user seal check were compared to fit testing results from two quantitative fit test methods: ambient aerosol and controlled negative pressure. In addition, equipment developed at the University of Cincinnati was used to measure in-mask pressures that are generated during the performance of NPUSCs. This technique was employed to assess the ability of respirator wearers to properly conduct user seal checks. The data were analyzed to determine if the user seal check procedure is an effective method for detecting known exhalation valve damage. All test subjects reported passing the user seal check with the undamaged valve. With the warped valve installed, 95 percent of test subjects reported passing the user seal check. With the slit valve installed, 73 percent of test subjects reported passing. With the dirty valve installed, 65 percent reported passing. All fit factors, measured with the damaged valves, were below the Occupational Safety and Health Administration-recognized pass/fail criteria except one fit test with the respirator equipped with the slit valve. Results from the in-mask pressure measurements confirmed whether or not the subject properly conducted a user seal check, but did not detect respirator leakage. In conclusion, the performance of a NPUSC rarely helped to identify damaged exhalation valves. These results support the need for respirator inspection prior to donning with periodic fit testing and the performance of user seal checks as necessary components of an adequate respiratory protection program.     

The effects of strapped spectacles on the fit factors of three manufactured brands of full facepiece negative pressure respirators.

A study was conducted to determine the effects of strapped spectacles on the fit factors obtained during quantitative fit testing on three different brands of full facepiece negative pressure respirators. The three brands of respirators were evaluated with and without strapped spectacles worn by the test subjects. A total of 180 quantitative fit testing trials were conducted on ten male test subjects. For each test subject, three quantitative fit testing trials were performed with each brand of respirator with and without the spectacles. The average of the fit testing trials for each subject with each respirator was used for statistical analysis. The results demonstrated that the fit factor values were significantly lower during use of the spectacles (p < 0.05). The estimated percentage of test subjects who failed the American National Standards Institute pass/fail criteria for quantitative fit testing (1000) increased by 15-36% when spectacles were worn.     

Respirator leakage in the pharmaceutical industry of northwest England

Field qualitative fit tests were conducted at 10 separate companies in the Northwest of England to determine the proportion of leaking respirators in a cross-section of pharmaceutical manufacturing industries. The 3 M FT-10 Qualitative Fit Test Apparatus was used to test a total of 211 half-face particulate respirator wearers. Participants wore their own respirators and were asked to don them as they would normally. In all cases, no specific intervention had occurred prior to testing. Results indicated a failure rate of 69% (of the 211 subjects tested, 145 respirators were leaking). Successful results were not associated with the frequency of use (p = 0.71) or years of experience wearing respirators (p = 0.59). Similarly, successful results were not associated with respirator training in the current job (p = 0.38) or training in previous jobs (p = 0.49). Leakage was not consistent across the 10 companies, with two companies exhibiting a 100% failure rate while another company had 26 successful tests in 50 wearers (52% pass rate). Only 35 of the 211 participants performed a negative pressure test. Of these, 80% successfully passed the test, which was significantly greater than the 22% pass rate among those who had not performed the pressure test (p < 0.001).     

Fit factors for quarter masks and facial size categories

Respirator fit testing is necessary before entering hazardous working environments to ensure that the respirator, when worn, satisfies a minimum fit and that the wearer knows when the respirator fits properly. In the many countries that do not have fit testing or total inward leakage regulations (including Korea), however, many workers wearing respirators may be potentially exposed to hazardous environments. It is necessary to suggest a useful tool to provide an alternative for fit testing in these countries. This study was conducted to evaluate fitting performance for quarter-mask respirators, and fit factors in facial size categories based on face lengths and lip lengths of the wearers. A total of 778 subjects (408 males, 370 females) were fit tested for three quarter masks: Sejin Co. SK-6 (Ulsan, Korea), Yongsung Co. YS-2010 S (Seoul, Korea), and 3 M Co. Series 7500 Medium (MN, USA) masks with a PortaCount 8020 (TSI Co., USA). A facial dimension survey of the subjects was conducted to develop facial size categories, on the basis of face length and lip length. Geometric mean fit factors (GMFFs) of Series 7500 Medium were found to be the highest of the three respirators. All of the respirators were more suitable for males than females in fitting performance. The Series 7500 Medium fitted a large number of the males tested, since the GMFFs for males were above 100 for every box of facial size categories, and high pass proportion rates were shown at an individual fit factor level of 100. The YS-2010 S provides an adequate fit for males in a limited range of facial dimensions. The Series 7500 Medium is more limited in providing adequate fit for females at specific facial dimensions than for males. For adequate fitting performance, the SK-6 is not preferentially recommended for Korean male and female workers due to low GMFFs and pass proportions. The result of this study indicates that after more accurate studies are performed, facial size categories, on the basis of facial dimensions, could be a useful tool to assist in the selection of adequately fitting respirators for workers in the countries having no fit testing requirements.     

Respiratory protection from isocyanate exposure in the autobody repair and refinishing industry

This study, part of the Survey of Painters and Repairers of Auto bodies by Yale (SPRAY), evaluated the effectiveness of respiratory protection against exposure to aliphatic polyisocyanates. A total of 36 shops were assessed for respiratory protection program completeness; 142 workers were measured for respirator fit factor (FF) using PortaCount Plus respirator fit tester. Twenty-two painters from 21 shops were sampled using NIOSH method 5525 to determine the workplace protection factor (WPF) of negative pressure, air-purifying half-facepiece respirators equipped with organic vapor cartridges and paint prefilters during spray-painting and priming activities. Only 11 shops (30%) had written respiratory protection programs. Eighty percent of all fit tested workers passed the test on the first try with FF >or= 100, and 92% passed the second test after respirator use training. Overall geometric mean (GM) FF was 1012 for all fit tested workers. Significant differences on pass rate (92% vs. 72%) and on FF (1990 vs. 736) were found between previously fit tested workers vs. nontested workers. Twenty-nine WPF samples were collected. The outside facepiece GM concentration of total isocyanate group (NCO) was 378.4 micro g NCO/m(3) with 96% concentrations exceeding the U.K. short-term exposure limit, 70 micro g NCO/m(3), but no in-facepiece concentrations exceeded the limit. The GM WPF of total NCO was 319 (GSD 4) and the 5th percentile was 54. WPF of total NCO was positively correlated with the duration of painting task. FF positively correlated with WPF when FF was 450. We conclude that negative pressure, air-purifying half-facepiece respirators equipped with organic vapor cartridges and paint prefilters provide effective protection against isocyanate exposure in spray and priming operations if workers are properly trained and fitted.     

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.     

Parameters that bias the measurement of airborne concentration within a respirator

This paper describes the theoretical basis upon which a test system has been set up to evaluate the sampling error associated with in-facepiece sampling on half-mask respirators. The in-facepiece sampling technique evaluated in this study is the one currently used in the U.S. to conduct quantitative facepiece fit testing. An experimental design was developed to study the sampling bias associated with in-facepiece sampling when selected parameters of the man/respirator system were varied. The results indicated that significant errors can be made in estimating concentration within a respirator when the current in-facepiece sampling technique is employed. Sampling bias was determined when in-facepiece samples were collected only during the inhalation phase of the respiratory cycles. They were found to range from greater than -99% to greater than +98%. The mean sampling bias was -17 +/- 38%. When measured in-facepiece concentrations were used to calculate a fit factor the resulting range was 44 to 4728 even though the actual fit factor was only 87. Based upon the data presented, it was hypothesized that faceseal leakage was streamlining within the respirator cavity. As a result, quantitative facepiece fit data on half-mask respirators may be biased by the large measurement error.     

Review of respirator performance testing in the workplace: issues and concerns.

Performance capability of respirators has traditionally been evaluated by testing components of the respirator (e.g., filter efficiency), facepiece fit, total inward leakage, or some other measure of performance evaluated under laboratory conditions. In recent years, increased emphasis has been placed on development of test methods suitable for evaluating respirator performance in the workplace. The goal of such testing is to evaluate the level of protection provided by respirators in the work environment. The AIHA Respiratory Protection Committee believes that workplace testing of respirators has the potential to be an excellent tool for increasing knowledge about the effectiveness of respiratory protection. However, a number of technical issues remain to be addressed before optimal test protocols and data analysis methods can be defined. The progress made to date in workplace testing will be reviewed, and broader discussion about key elements that must be considered when developing guidelines for testing respirators in the workplace will be initiated.     

Correlation of qualitative and quantitative results from testing respirator fit

Three qualitative respirator fit tests were evaluated for their ability to adequately measure respiratory protection. The evaluated methods were the negative pressure test, the isoamyl acetate test, and the irritant smoke test. Each test was performed concurrently with a single quantitative fit test, the dioctylphthalate (DOP) test, during 274 half-mask and 274 full facepiece wearings. The quantitative values of DOP penetration obtained after passing or failing each qualitative fit test were lognormally distributed. For each qualitative test performed on each mask type, the average log penetration values obtained after passing and failing each test were statistically different from each other. The mean of the log penetration values associated with the failed qualitative test was always larger than the mean of the log penetration values associated with passed qualitative tests for all three qualitative methods. Most (95%) of the tested study had adequately fitting respirators as determined by quantitative testing. Of these subjects, 96% to 100% passed the qualitative fit tests. Of the 5% of the study subjects with inadequately fitting half mask respirators, 93% to 100% of the inadequate fits were detected by qualitative methods. Twenty three to 46% of the poorly fitting full face masks were detected by qualitative methods. The probability of passing or failing a qualitative test with an inadequately fitting respirator can be estimated; however, the uncertainty associated with each estimate is large due to the small number of study subjects with poorly fitting respirators.     

Correlation between respirator fit and respirator fit test panel cells by respirator size

The National Institute for Occupational Safety and Health (NIOSH), recognizing the difficulties inherent in using old military data to define modern industrial respirator fit test panels, recently completed a study to develop an anthropometric database of the measurements of heads and faces of civilian respirator users. Based on the data collected, NIOSH researchers developed two new panels for fit testing half-facepiece and full-facepiece respirators. One of the new panels (NIOSH bivariate panel) uses face length and face width. The other panel is based on principal component analysis (PCA) to identify the linear combination of facial dimensions that best explains facial variations. The objective of this study was to investigate the correlation between respirator fit and the new NIOSH respirator fit test panel cells for various respirator sizes. This study was carried out on 30 subjects that were selected in part using the new NIOSH bivariate panel. Fit tests were conducted on the test subjects using a PORTACOUNT device and three exercises. Each subject was tested with three replications of four models of P-100 half-facepiece respirators in three sizes. This study found that respirator size significantly influenced fit within a given panel cell. Face size categories also matched the respirator sizing reasonably well, in that the small, medium, and large face size categories achieved the highest geometric mean fit factors in the small, medium, and large respirator sizes, respectively. The same pattern holds for fit test passing rate. Therefore, a correlation was found between respirator fit and the new NIOSH bivariate fit test panel cells for various respirator sizes. Face sizes classified by the PCA panel also followed a similar pattern with respirator fit although not quite as consistently. For the LANL panel, however, both small and medium faces achieved best fit in small size respirators, and large faces achieved best fit in medium respirators. These findings support the selection of the facial dimensions for developing the new NIOSH bivariate respirator fit test panel.     

Simplified pressure method for respirator fit testing

A simplified pressure method has been developed for fit testing air-purifying respirators. In this method, the air-purifying cartridges are replaced by a pressure-sensing attachment and a valve. While wearers hold their breath, a small pump extracts air from the respirator cavity until a steady-state pressure is reached in 1 to 2 sec. The flow rate through the face seal leak is a unique function of this pressure, which is determined once for all respirators, regardless of the respirator's cavity volume or deformation because of pliability. The contaminant concentration inside the respirator depends on the degree of dilution by the flow through the cartridges. The cartridge flow varies among different brands and is measured once for each brand. The ratio of cartridge to leakflow is a measure of fit. This flow ratio has been measured on human subjects and has been compared to fit factors determined on the same subjects by means of photometric and particle count tests. The aerosol tests gave higher values of fit.