Determining The Initial Efficiency of Materials Used in Medical Face Masks To Penetration by Particulates Using Latex Spheres
Determining The Initial Efficiency of Materials Used in Medical Face Masks To Penetration by Particulates Using Latex Spheres
Determining The Initial Efficiency of Materials Used in Medical Face Masks To Penetration by Particulates Using Latex Spheres
for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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3.1.3 monodispersion, n—scattering of discrete particles in 6.2.3 Aerosol generator,
an airflow where the size is centralized about a specific particle 6.2.4 Charge neutralizer,
size. 6.2.5 Humidifier,
3.1.3.1 Discussion—In this test method, the monodispersed 6.2.6 Test filter holder and duct assembly,
particle distribution has a mean diameter size of the aerosol in 6.2.7 Pressure drop measuring device,
the 0.1 to 5 µm range, with a coefficient of variation of the 6.2.8 Air flow rate measuring device,
mean diameter of 610 % or less, as certified by the manufac- 6.2.9 Temperature and relative humidity detectors,
turer. 6.2.10 Air blower (optional for negative pressure system),
3.2 For definitions of other protective clothing-related terms and
used in this test method, refer to Terminology F1494. 6.2.11 Optical particle counters.
4 5
Symposium on Gas and Liquid Filtration, ASTM STP 975, ASTM, Vol 11, Raabe, O., “The Dilution of Monodispersed Suspensions for Aerosolization,”
1986, pp. 141-164. American Industrial Hygiene Association Journal, Vol 29, 1968, pp. 439–443.
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7.3 Aerosol Neutralizer—This procedure recommends the system. This technique generally will ensure aerosol surface
use of an aerosol charge neutralizer at the inlet of the test charge stability. The aerosol neutralizer can be in the form of a
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FIG. 2 Atomizer
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7.7 Pressure Drop Measurement: mounting volume are to be less than 10 % of the total test system flow
7.7.1 Use static pressure taps that are flush with the duct rate.
walls at a distance of 1 duct diameter upstream and down- 7.9 Aerosol Concentration Counting:
stream of the filter medium faces. 7.9.1 This practice is structured for utilizing automatic,
7.7.2 With no filter medium in the sample holder, there shall single particle light-scattering counters. For an illustration of
be no measurable pressure loss between the inlet-side and the application, calibration, and analyses by these instruments,
outlet-side pressure taps. Use a pressure-measuring instrument refer to Practices F50 and F328.
capable of being read to 60.025 cm of water gauge to make 7.9.2 Generally, single particle light-scattering counters
this determination. measure in the range of 0.1 to 15 µm equivalent spherical
diameter, with a single particle measurement dynamic range of
7.8 Aerosol Sample Extraction and Transport—Use geo-
50 to 1. These instruments shall be calibrated within the test
metrically and kinematically identical centerline probes to
system, similar to the manufacturer’s standard calibration and
extract representative aerosols from the inlet and outlet sides of
with the test aerosol as conditioned for the efficiency testing.
the material specimen test section. Use probes that have a
For efficiencies approaching 99.9 % and greater, a higher test
radius of curvature (R) of 12 cm or R/D (Diameter) > 20:1 and
inlet aerosol concentration is usually required to maintain
present a cross-sectional area of less than 10 % of the cross-
reasonable sampling times at the outlet. If these conditions
sectional area of the test system ducting. Locate the upstream
exceed the suggested coincidence limits for the single particle
probe 8 duct diameters (minimum) downstream of the aerosol
counters, an inlet dilution at the optical particle counter of the
injection point and 2 duct diameters ahead of the material
aerosol is required. Achieve inlet dilution by passing some
specimen. Locate the downstream probe 3 duct diameters
portion of the conditioned inlet aerosol through a HEPA-grade
downstream of the filter medium specimen. To minimize
filter and remixing it with the sampled inlet aerosol to the
aerosol sampling transport line losses due to settling, diffusion,
light-scattering particle counter.
and inertia for the aerosol particle size range of the test method,
7.9.3 Establish accurate dilution ratios in order to specify
use the following characteristics of the sampling.
the exact aerosol sample volume extracted from the inlet flow
7.8.1 Maintain the sampling line flow in the laminar flow
for aerosol particle counting. Recommended sampling times
regime; that is, the Reynolds number must be less than 1000.
are on the order of 10 to 60 s. If separate particle counters are
Calculate the Reynolds number in accordance with the follow-
used for inlet and outlet aerosol concentrations, they must be
ing formula:
calibrated for the aerosol particle size and concentration
ρ g VD1 response needed within the test system.
Re# 5 (1)
µg
NOTE 6—The flow rate of the respective optical particle counter must be
where: measured and recorded.
NOTE 7—For test system changes in sampling configuration, that is,
ρg = gas density (kg/m3), alternate upstream and downstream sampling or opening and closing the
V = gas velocity (m/s), aerosol flow system, allow a purge time so that 25 sampling line volume
D1 = inside diameter of sampling lines (m), and changes can occur before counting resumes. (For flow rates of 7 L/min in
µg = gas viscosity (kg/m-s). 6 mm ID samplings, the purge time will be between 10 to 15 s.)
7.8.2 Limit horizontal sampling line length to less than 8. Number of Downstream/Upstream Sampling Intervals
100 cm and the total sample transport line to less than 2 m.
7.8.3 Maintain all radius of curvatures to greater than 8.1 The statistical selection of the number of downstream/
12 cm. upstream sampling intervals is based on no specimen present in
the filter holder. The test apparatus must meet a 100 6 1 %
NOTE 4—Isokinetic aerosol sampling is recommended to minimize penetration average with a coefficient of variation of 3 %. Use
probe inlet losses. However, in those cases where isokinetic conditions the procedure in 8.2 to obtain this selection. Run this procedure
cannot be met, it is recommended that the operation of these probes be
610 % of isokinetic or that the particle Stokes number at the probe inlet twice and use the number of the two results.
be held to less than 1.0 in order to minimize inertial losses at the probe 8.2 Procedure:
inlet. It is also recommended that the Reynolds number of the sample flow
lines be held to less than 2000. The Stokes number is calculated using the
8.2.1 Obtain two consecutive downstream/upstream
following formula: (100 %) penetration sample observations. Calculate their aver-
age.
D 2p ρ p VC 8.2.2 If the average is between 99 and 101 %, proceed to
St# 5 (2)
9µ g D n 8.2.4. If the average is not between 99 and 101 %, run another
where: sample and average it with the previous two samples.
Dp = particle diameter (m), 8.2.3 If the new average is between 99 and 101 %, proceed
ρp = particle density (kg/m), to 8.2.4. If not, continue this process until 100 6 1 %
V = velocity of approach (m/s), penetration is achieved. If 100 % penetration is not achieved,
µg = gas viscosity (kg/m-s), the test apparatus is biased and must be corrected.
Dn = diameter of sampling nozzle (m), and 8.2.4 Subtract the highest test sample observation from the
C = Cunningham correction factor, which for particles lowest sample to give the sample range at that certain number
larger than 1.0 × 10–6 m (1 µm) is assumed to be 1.0. of sample observations. Go to Table 1 for that number of
NOTE 5—Recommended sampling flow rates for extraction of the observations and read the adjustment number.
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TABLE 1 Number of Sampling IntervalsA an individual closed container to avoid unnecessary contami-
Number of Adjust if Range nation and handling prior to testing.
Observations is Greater Than
2 4.155
3 4.965
10. Test Procedure
4 5.445 10.1 System Start-Up:
5 5.790
6 6.045 10.1.1 Set main airflow, dilution airflow, and aerosol gen-
7 6.255 erator airflow to test conditions,
8 6.435
9 6.585
10.1.2 Establish airflow controls at required test face veloci-
10 6.705 ties as to have air dilution (drying) for aerosol generation of 2:1
11 6.825 or greater. Purge main airflow for 10 to 15 min,
12 6.930
13 7.035
10.1.3 Warm up optical particle counter (OPC) for 15 to
14 7.110 30 min,
15 7.200 10.1.4 After OPC warm-up, check built-in calibration signal
16 7.275
17 7.335
or OPC output signal on an oscilloscope for stable gain on
18 7.395 photomultiplier tube or other optical detectors.
19 7.455
20 7.515 NOTE 8—This test is conducted with filtered ambient air flowing
A through the OPC.
Compare the sample range to the adjustment number.
10.1.5 Switch the OPC into the main airflow and balance
OPC airflow against the main airflow. Observe OPC count
8.2.5 The adjustment number is the greatest range for a data.
coefficient of variation of 3 % at a penetration of 100 6 1 % for 10.2 Aerosol Drying Verification:
the specified number of observations. 10.2.1 Set up the aerosol generator with a nominal volume
8.2.6 If the sample range is equal to or less than the of the distilled water to be used in the latex dilutions.
adjustment number, the number of sample observations is the 10.2.2 Without a material specimen in the test system,
number of downstream/upstream sampling intervals for filter establish the main system airflow and the OPC sampling
testing. If the sampling range is greater than the adjustment airflow for the upstream sampling probe.
number, then another 100 % penetration sampling observation 10.2.3 Sample the upstream and downstream airflow for
must be run. 1 min each.
8.2.7 If the new penetration is greater or less than the
10.2.4 Verify complete drying of the aerosol droplets by
bounds of the past data, a new range is calculated. If, at the new
comparing these counts to counts obtained in 10.1.5.
number of sample observations, the new range is greater than
10.2.5 Record the relative humidity and the temperature of
the new adjustment number, this process is repeated until the
the airflow.
sample range is less than the adjustment number. That number
10.2.6 Run this drying test for approximately 1 h, sampling
of sample observations is the number of downstream/upstream
every 15 min for upstream and downstream counting and
sampling intervals used for filter testing.
record aerosol stability and system relative humidity. Measure
8.2.8 If in a suitable number of intervals it is found that the
the water consumption of the aerosol generator.
sample range will always be greater than the adjustment
10.2.7 Record any dilution airflow and the required air
number at 20 observations, then the 100 % penetration data is
pressure for the aerosol generator.
too variable and action must be taken to correct the particle
concentration variability or the particle-counting methodology. 10.3 Aerosol Stability and Zero Effıciency Check:
10.3.1 Fill the aerosol generator with the desired dilution of
9. Material Specimen Selection and Conditioning latex suspension, Without a filter media sample in the test
9.1 Measure material thickness and unit area weight in system, close the system and establish the required system
accordance with Test Methods D1777 and D3776/D3776M, airflows.
respectively. 10.3.2 Stabilize the system airflow with the aerosol suspen-
9.2 Apply a sealing force that does not distort or influence sion for approximately 5 min, then begin successive 1-min
the integrity or continuity of the material specimen. upstream and downstream counts for 15 min or until reproduc-
ible counts are established. Reproducibility is to meet the
9.3 Use a total of five different material specimens. For sampling criteria in Section 8.
statistical-based sampling, choose a number of material speci- 10.3.3 Verify that counting is within a 10 % coincidence of
mens as indicated in Practice D2905 or Methods F778. the OPC.
9.4 If no prior efficiency criteria are available for a specific NOTE 9—The OPC channels to be used for counting include channels
material, sample to establish a 95 % confidence level about the either side of the maximum count channel that produce a count of 50 % of
mean efficiency. the maximum channel count or greater.
NOTE 10—There must be a clear minimum channel separation in the
9.5 Precondition each material specimen at the test duct OPC between any residue particle distribution and the latex particle
conditions at 30 to 50 6 5 % relative humidity and a distribution in the test aerosol. If necessary, adjust the gain on the OPC to
temperature of 21 6 3 °C [70 6 5 °F]. Retain all specimens in establish this separation.
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10.4 Effıciency Test: TABLE 2 Calculated Efficiencies Versus Particle Diameter
10.4.1 Install the material specimen in the test system and Particle Diameter/ Face Pressure
Efficiency
Material Std. Deviation Velocity Drop
re-establish the required airflows. Identification
Std.
10.4.2 Monitor the OPC airflow and adjust for the added Dp, µm
Deviation
cm/s kPa %
material specimen P on the sample flow. ABC-1 1.0 0.001 10 0.25 95
10.4.3 Record the temperature, the relative humidity of the
test airflow, and the P of the filter media.
10.4.4 Sample and record the upstream and downstream TABLE 3 High Variability Range
aerosol counts for a minimum of five counts at each position Standard Percent Variation 95 %
Mean
using a 1-min sampling time. Deviation Confidence Level
Laboratory 1 −0.5.599 0.1328 4.76
NOTE 11—If the downstream count is less than 100, extend the Laboratory 2 −0.5.969 0.2241 7.54
sampling time until 100 counts are obtained. However, do not count Average 6.15
longer than 5 min to avoid loading the material specimen.
10.4.5 Monitor the upstream counts; if these counts fall
outside the criteria of 8.1, stop the test and check the system for TABLE 4 Low Variability Range
aerosol generation instability. Mean
Standard Percent Variation 95 %
Deviation Confidence Level
10.4.6 Average the upstream counts and the downstream
Laboratory 3 –1.6429 0.0310 3.80
counts, then calculate the decimal efficiency by the following Laboratory 4 –1.6961 0.0273 3.24
definition: Laboratory 5 –1.7057 0.0272 3.20
Average 3.41
~ average downstream counts!
Efficiency 5 1 2 penetration 5 1 2
~ average upstream counts!
TABLE 5 Components of Variance
11. Calculations Component
Percent of Total Estimated Standard
Source of
11.1 Prior to the calculations of efficiency, any corrections Variance
Variance Deviation
for background aerosol or apparent background aerosol must Laboratory 0.067362 66.54 0.259542
be made to the single particle light-scattering counters. If the Sample 0.012329 12.18 0.111037
background count aerosol exceeds 1 % of the outlet Run 0.021543 21.28 0.146776
Total 0.101235 0.318174
concentration, verify the integrity of the light-scattering par-
ticle counter, then make corrections through the following
equations: TABLE 6 Components of Variance
inlet concentration 5 inlet aerosol count 2 inlet background count, and Component
Percent of Total Estimated Standard
outlet concentration 2 outlet aerosol count 2 inlet background count Source of
Variance Deviation
Variance
11.2 Calculate the aerosol filtration efficiency for a specific Laboratory 0.001088 55.15 0.329880
particle size using the following formula: Sample 0.000386 19.54 0.019636
Run 0.000499 25.31 0.022345
η ~ D p ! 5 @ 1 2 P ~ D p ! # 100 (3) Total 0.001973 0.044420
where:
P(Dp) = the penetration, and
P(Dp) = (downstream particle concentration) / (upstream 12.1.5 Test results showing the date tested, number of
particle concentration). specimens tested, the location of the specimens from the
material or protective clothing sample, and the percent pen-
12. Report etration for each particle size on each specimen. Prepare a table
12.1 Report the following information: listing the calculated efficiencies versus the particle diameter,
12.1.1 Description of the medical face mask material tested, the face velocity (flow rate) and the pressure drop. See Table 2.
including its identification, description, manufacturer, lot iden- 12.1.6 Document results in accordance with Guide F2053.
tification or manufacture date, thickness, basis weight, and an
13. Precision and Bias
indication of any treatment prior to testing.
12.1.2 A description of the specific challenge particles used, 13.1 No justifiable statement of accuracy can be made since
including the size distribution, and percent concentration. the filtration penetration of a material cannot be established by
12.1.3 Details for the specific testing conducted including an independent referee method and since no reproducible
the temperature, relative humidity, exposed specimen area, standard material specimens exist.
flowrate, pressure drop, test duration, test sensitivity, and 13.2 Precision Analysis:
controls used in the testing. 13.2.1 Filtration penetration mechanisms through flat-sheet
12.1.4 An identification of the aerosol generator, the system fibrous filter material is an exponential function with changes
flow meters and the particle counters with their current in filter structure (basis weight, fiber size, and/or porosity) and
calibrations. with changes in filter challenge (face velocity, particle size,
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particle structure and/or particle electrostatic charge). The fraction of this test at a challenge of 2.0-µm sphere diameter
statistical distribution function for penetration data is, and 1-cm/s face velocity is 6.15 % at the 95 % confidence
therefore, approximated as log-normal. This means that the level. See Table 3.
penetration data must be transformed prior to statistical ma- 13.3.2 Low Variability Range (Small Spheres, High Face
nipulation by taking the natural logarithm of each measured Velocity)—The average single laboratory/single operator per-
penetration fraction (%P (Dp) / 100). After statistical cent variation of the natural logarithms of the penetration
manipulation, take the antilog of the natural logarithm of the fraction of this test at a challenge of 0.62-µm sphere diameter
mean penetration (geometric mean) and use this mean penetra- and 25-cm/s face velocity is 3.41 % at the 95 % confidence
tion to calculate the efficiency. If the antilog of the standard level. See Table 4.
deviation of the transformed data is taken, it is called the 13.4 Multilaboratory-Single Operator Precision—Two re-
geometric standard deviation. If the data are not transformed, gimes of variability are presented.
then variability is an exponential function with penetration 13.4.1 High Variability Range (Large Spheres, Low Face
range, creating a situation where the lower the penetration, the Velocity)—The multilaboratory/single operator percent varia-
greater the variability. tion of the natural logarithms of the penetration fraction of this
13.2.2 Variability in this section is reported as the percent test between two laboratories is 8.95 % at the 95 % confidence
coefficient of variation of the transformed data at the 95 % level.
confidence level. Means are negative, since the natural loga- 13.4.2 Low Variability Range (Small Spheres, High Face
rithms of numbers less than one are negative. Velocity)—The multilaboratory/single operator variation of the
13.2.3 A first multilaboratory experiment, published in STP natural logarithms of the penetration fraction of this test
9757 showed that when sphere diameter and face velocity are between three laboratories is 3.94 % at the 95 % confidence
varied, a high region of variability (large spheres, low face level.
velocity) and a low region of variability (small spheres, high
face velocity) exist. Precision statements for each of these 13.5 Analysis of Component of Variance:
regions would provide the range of possible variability for this 13.5.1 High Variability Range (Large Spheres, Low Face
test. Velocity)—Two laboratories ran data on two runs of 25 fiber-
13.2.4 A second multilaboratory experiment was performed glass paper filters of low variability challenged with 2.02-µm
in the format of two three-level completely nested designed spheres at 1-cm/s face velocity. Results on the different
experiments. The output from these designs gave the single components of variance of the natural logarithms of the
laboratory/single operator precision, the multilaboratory/single penetration fractions are presented in Table 5.
laboratory precision, and also an analysis of the contribution of 13.5.2 Low Variability Range (Small Spheres, High Face
the separate components of the total variance—laboratory, Velocity)—Three laboratories ran data on two runs of 25
sample, and run duplication. One experiment was run at the fiberglass paper filters of low variability challenged with
region of high variability, the other was run in the region of low 0.62-µm spheres at 25-cm/s face velocity. Results on the
variability. The filters used were of flat fiberglass paper of low different components of variance of the natural logarithms of
variability. Standard deviations presented here are based on n, the penetration fraction are presented in Table 6.
not (n − 1). 13.5.3 Discussion—In each of these regimes of high and
low variabilities, over 80 % of the variance is attributable to
13.3 Single Laboratory/Single Operator Precision—Two re- differences between laboratories and their ability to reproduce
gimes of variability are presented. data.
13.3.1 High Variability Range (Large Spheres, Low Face
Velocity)—The average single laboratory/single operator per- NOTE 12—An analysis of variance gives a standard deviation based on
not (n − 1).
cent variation of the natural logarithms of the penetration
14. Keywords
7
Symposium on Gas and Liquid Filtration, ASTM STP 973, ASTM, Vol 1, 1986, 14.1 filtration; medical face mask; particle filtration effi-
pp. 141–151. ciency; particles; particulate
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