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Defence Research and Development Canada Contract Report DRDC-RDDC-2019-C142 July 2019 CAN UNCLASSIFIED CAN UNCLASSIFIED Standard Testing Methods for Various Respirator Functions Linda Tremblay 1,2 Nicole Laidlaw 1,2 Tim Ho 1,2 1 Calian Technologies, Ottawa, ON, Canada 2 CBRN Protection Group, Department of Chemistry and Chemical Engineering, Royal Military College, Kingston, ON, Canada Prepared by: Calian Technologies 340 Legget Dr Ste 101 Ottawa ON K2K 1Y6 RMC TR CPT-1901 PSPC Contract Number: W0046-19-131 Technical Authority: Eva Frances Dickson, Defence Scientist Contractor's date of publication: March 2019

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Page 1: Standard Testing Methods for Various Respirator Functions · Figure 27: Diffusion dryer water collector and purple silica within the diffusion dryer. ..... 29 Figure 28: Starting

Defence Research and Development Canada Contract Report DRDC-RDDC-2019-C142 July 2019

CAN UNCLASSIFIED

CAN UNCLASSIFIED

Standard Testing Methods for Various Respirator Functions

Linda Tremblay1,2 Nicole Laidlaw1,2 Tim Ho1,2 1Calian Technologies, Ottawa, ON, Canada 2CBRN Protection Group, Department of Chemistry and Chemical Engineering, Royal Military College, Kingston, ON, Canada Prepared by: Calian Technologies 340 Legget Dr Ste 101 Ottawa ON K2K 1Y6 RMC TR CPT-1901 PSPC Contract Number: W0046-19-131 Technical Authority: Eva Frances Dickson, Defence Scientist Contractor's date of publication: March 2019

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Template in use: EO Publishing App for CR-EL Eng 2018-12-17-v1.dotm

© Her Majesty the Queen in Right of Canada (Department of National Defence), 2019 © Sa Majesté la Reine en droit du Canada (Ministère de la Défense nationale), 2019

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IMPORTANT INFORMATIVE STATEMENTS

This document was reviewed for Controlled Goods by Defence Research and Development Canada using the Schedule to the Defence Production Act.

Disclaimer: This document is not published by the Editorial Office of Defence Research and Development Canada, an agency of the Department of National Defence of Canada but is to be catalogued in the Canadian Defence Information System (CANDIS), the national repository for Defence S&T documents. Her Majesty the Queen in Right of Canada (Department of National Defence) makes no representations or warranties, expressed or implied, of any kind whatsoever, and assumes no liability for the accuracy, reliability, completeness, currency or usefulness of any information, product, process or material included in this document. Nothing in this document should be interpreted as an endorsement for the specific use of any tool, technique or process examined in it. Any reliance on, or use of, any information, product, process or material included in this document is at the sole risk of the person so using it or relying on it. Canada does not assume any liability in respect of any damages or losses arising out of or in connection with the use of, or reliance on, any information, product, process or material included in this document.

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Standard Testing Methods for Various Respirator Functions

Deliverable under #2018-020-SLA Project 001

Linda Tremblay1,2, Nicole Laidlaw1,2, Tim Ho1,2

1. Calian Technologies, Ottawa, ON, Canada

2. CBRN Protection Group, Dept. of Chemistry & Chemical Engineering, Royal Military College of Canada, Kingston, ON, Canada

Royal Military College of Canada Technical Report RMC TR CPT-1901 March 2019

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IMPORTANT INFORMATIVE STATEMENTS

This document was reviewed for Controlled Goods using the Guide to Canada's Export Controls.

Mention of a particular commercially-available product in no way implies endorsement or full suitability for an application.

© Her Majesty the Queen in Right of Canada, as represented by the Minister of National Defence, 2019

© Sa Majesté la Reine (en droit du Canada), telle que représentée par le ministre de la Défense nationale, 2019

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Abstract….

The Royal Military College of Canada (RMC) is a test centre for respirator testing for the Canadian Armed Forces (CAF).

This report presents the procedures developed and performed by RMC, as directed by Defence Research and Development Canada, to test protective respiratory devices according to selected standards set out in US Federal Regulation 42 CFR 84 and by the National Institute for Occupational Safety and Health for air flow resistance, particulate filtration efficiency, and exhalation valve leakage.

Resumé …….

Le Collège militaire royal du Canada (CMR) est un centre d’essai de respirateurs pour les Forces armées canadiennes (FAC).

Le présent rapport présente les procédures élaborées et appliquées par le CMR, comme prescrit par Recherche et développement pour la défense Canada, pour tester les dispositifs respiratoires de protection conformément aux normes choisies établies dans le titre 42, partie 84 du Code of Federal Regulations et par le National Institute for Occupational Safety and Health pour la résistance au débit d’air, l’efficacité de la filtration des particules et la non-étanchéité de la soupape d’expiration.

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Table of contents

Abstract…. ..................................................................................................................................... iiiResumé ……. ................................................................................................................................. iiiTable of contents ............................................................................................................................ ivList of figures ................................................................................................................................. viList of tables ................................................................................................................................. viiiAcknowledgements ........................................................................................................................ ix1 Scope……. ................................................................................................................................ 13 References ................................................................................................................................. 24 List of abbreviations and acronyms .......................................................................................... 4

Air flow resistance ......................................................................................................... 6Annex AA.1 Purpose ............................................................................................................................ 6A.2 Safety ............................................................................................................................... 6A.3 Material requirements ...................................................................................................... 6

A.3.1 Test equipment – Air flow resistance .................................................................. 6A.3.2 Test equipment – inward leakage ........................................................................ 7

A.4 Procedure ......................................................................................................................... 8A.4.1 Airflow resistance testing setup .......................................................................... 8A.4.2 Inward leakage testing setup ............................................................................... 9A.4.3 Setup for both airflow resistance testing and inward leakage testing using

dual-arm headstand ........................................................................................... 10A.4.4 Experimental Procedure .................................................................................... 10A.4.5 Analysis ............................................................................................................. 11

Efficiency test of non-powered air-purifying particulate filter .................................... 12Annex BB.1 Purpose .......................................................................................................................... 12B.2 Safety ............................................................................................................................. 13B.3 Material Requirements .................................................................................................. 14B.4 General sequence of procedures .................................................................................... 14

B.4.1 Equipment setup and procedure for particulate concentration determination ... 14B.4.2 Particle size distribution measurement .............................................................. 16B.4.3 Equipment setup and method for filtration efficiency ....................................... 17

B.5 PortaCount Calibration .................................................................................................. 19B.6 Diluter ............................................................................................................................ 20B.7 Green Line Filter Test.................................................................................................... 24B.8 Scanning Mobility Particle Sizer calibration ................................................................. 25

B.8.1 Purpose .............................................................................................................. 25B.8.2 Safety ................................................................................................................. 25B.8.3 Material ............................................................................................................. 25

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B.8.4 Procedure ........................................................................................................... 26B.9 Data Collection Sheet .................................................................................................... 34

Exhalation Valve Leakage in a Non-Powered Air-Purifying Respirator. ................... 36Annex CC.1 Purpose .......................................................................................................................... 36C.2 Safety ............................................................................................................................. 36C.3 Material .......................................................................................................................... 36C.4 Procedure ....................................................................................................................... 36

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List of figures

Figure 1: Configuration used for inhalation pressure drop testing. ................................................. 8

Figure 2: Configuration used for exhalation pressure drop testing. ................................................ 9

Figure 3: Test apparatus with breathing headform (single PortaCount configuration). .................. 9

Figure 4: One possible setup for inhalation resistance testing with dual-arm headstand. The equipment in red on the upper arm of headstand diagram is used for IL testing and the remaining equipment connected to the lower arm of headstand diagram is used for airflow resistance testing. ...................................................................................... 10

Figure 5: Block diagram of the concentration measurement apparatus. ....................................... 15

Figure 6: Photographs of general setup for concentration experiment. a) overview of entire apparatus; b) GAST blower; c) needle valve and flowmeter; d) mounting apparatus in wall of chamber. ..................................................................................... 15

Figure 7: Block diagram of measurement apparatus for filtration efficiency. ............................... 17

Figure 8: Photographs showing additional PortaCount required for percent efficiency experiment. a) overview of entire setup; b) addition of a second (post filter) PortaCount ................................................................................................................... 18

Figure 9: Diagram of General PortaCount Calibration setup. ....................................................... 19

Figure 10: Capillary tube with end caps in place .......................................................................... 20

Figure 11: Label on the capillary tube container ........................................................................... 20

Figure 12: RMC custom diluter – side views ................................................................................ 20

Figure 13: RMC custom diluter – top view ................................................................................... 20

Figure 14: RMC custom diluter – bottom view ............................................................................. 21

Figure 15:Removing screws to open diluter .................................................................................. 21

Figure 16: Open diluter with exposed capillary tube .................................................................... 22

Figure 17: Replacing the capillary tube ......................................................................................... 22

Figure 18: Rinsing the capillary tube ............................................................................................ 22

Figure 19: Ultrasonicator controls ................................................................................................. 23

Figure 20: Suspension of capillary tubes in ultrasonicator ............................................................ 23

Figure 21: Drying the capillary tube.............................................................................................. 24

Figure 22: Diagram of Green Line filter testing setup with the added pressure sensor. ............... 24

Figure 23: Schematic of the SMPS calibration setup. ................................................................... 26

Figure 24: Example of status screen showing errors during warming up of CPC (left); example of status screen showing a ready CPC (right). .............................................. 27

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Figure 25: Photograph of the calibration setup, not including the SMPS. Note that the stirrer and cork ring are only used to raise and support the sample bottle. ............................ 27

Figure 26: Photograph of the SMPS. ............................................................................................. 28

Figure 27: Diffusion dryer water collector and purple silica within the diffusion dryer. .............. 29

Figure 28: Starting new run on AIM software. New file is circled in red. .................................... 29

Figure 29: Confirmation of file type for running the SMPS ......................................................... 30

Figure 30: Hardware settings on the SMPS properties window. ................................................... 31

Figure 31: Image of impactor location and label ........................................................................... 31

Figure 32: Scheduling tab on the SMPS properties window. ........................................................ 32

Figure 33: 4 different windows of AIM software. First window top left is the size data graph, window top right is size data table (raw data), bottom left is the sample list and bottom right is the statistics table. ............................................................................... 33

Figure 34: Finished run of a 0.1 micron sphere sample showing a highest sample peak at 0.947 micron diameter seen in the size data graph window and in the mode row in the statistics table window........................................................................................... 33

Figure 35: Face-on and aerial view on MITA apparatus and close up of exhalation valve adapters, where A – PortaCount apparatus; B – MITA Headform; C – MITA module/screen; D – Exhalation Valve Adapters. ........................................................ 37

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List of tables

Table 1: Modified breathing machine rates programmed to give flow rates equivalent to Standard Breathing Rates for an ISO Standard Man [9]. .......................................................... 8

Table 2: Required parameters for method when using oil as test challenge. ................................. 13

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Acknowledgements

The project was directed by Dr. Eva Dickson of Defence Research and Development Canada (DRDC) who provided guidance for the study and the reporting.

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1 Scope…….

The following document describes the methods used at the Royal Military College of Canada (RMC) for testing a protective respiratory device to the standards set out in US Federal Regulations and by the National Institute for Occupational Safety and Health (NIOSH) [1]-[4].

2 Methods

It is important to note that the methods below can be applicable to multiple types of respirators and canisters. They can be used to test both full face masks and half-masks. Each method has its own set of equipment, procedures and safety concerns that will be listed in the following.

2.1 Air Flow Resistance

The method used for testing airflow resistance was based on the methods presented in both the NIOSH standard methods [5][6]and the previous work done at RMC [7]. It is presented in detail in Annex A. In brief, the respirator was mounted on a custom-built ISO headform. The fit factor was measured to assure a reasonable fit of the respirator to the headform. Air was then pulled (inhalation) or pushed (exhalation) through the respirator and the pressure drop was measured

2.2 Particulate Filtration Efficiency

Due to not having all equipment specified in the NIOSH standard testing procedure, a modified Standard Operation Procedure (SOP) was determined for this specific experiment [2]. The SOP can be found in Annex B. In summary, 20 canisters are subjected to a specific concentration of oil particulates for a known amount of time (until the challenge concentration is met). The particles before and after the canister are monitored for the duration of the experiment to calculate the percent efficiency.

2.3 Exhalation Valve Leakage

Due to equipment that differs from the apparatus specified in the NIOSH standard testing procedure, a modified SOP was determined for this specific experiment, as found in Annex C [3]. In brief, the exhalation valve is connected the Mask Integrity Test Accessory (MITA) and the instrument is set to test. A pressure is applied to the exhalation valve and a change in pressure is monitored for a short period of time to give the leakage flow.

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3 References

[1] US Code of Federal Regulations (2017) 42 CFR 84 – Approval of Respiratory Protective Devices

[2] NIOSH (2016). Determination of Particulate Filtration efficiency Level for P100 Series Filters Against Liquid Particulates for Non-Powered, Air-Purifying Respirators Standard Testing Procedure (STP). 3.1

[3] NIOSH (2014). Determination of Exhalation Valve Leakage Test, Air-Purifying Respirators Standard Testing Procedure (STP). 2.1

[4] NIOSH (2003). Statement of Standard for Chemical, Biological, Radiological, and Nuclear (CBRN) Full Facepiece Air Purifying Respirator (APR). https://www.cdc.gov/niosh/npptl/standardsdev/cbrn/apr/standard/aprstd-a.html.

[5] NIOSH (2014). Determination of Inhalation Resistance Test, Air-Purifying Respirators Standard Testing Procedure (STP). 2.2

[6] NIOSH (2014). Determination of Exhalation Resistance Test, Air-Purifying Respirators Standard Testing Procedure (STP). 2.3

[7] Bodurtha P., Tremblay L., Farrar G. (2017). Joint CBRN General Service Respirator Bid Evaluation: RMCC test plan Phase 2D (Test and Demonstration). P. Bodurtha, L. Tremblay and G. Farrar. Royal Military College of Canada Report CPT-1601. DRDC-RDDC-2017-C153.

[8] International Organization for Standardization (2015). ISO TS 16976-2. Respiratory protective devices – Human factors – Part 2: Anthropometrics.

[9] International Organization for Standardization (2015). ISO TS 16976-1. Respiratory protective devices – Human factors – Part 1: Metabolic rates and respiratory flow rates.

[10] Bodurtha P., Abbott T. (2016). “Equipment Maintenance standard operating procedures for performing QNFT and SWPF testing: TSI Portacounts, aerosol generators and RMC custom-designed Diluters.” RMC technical report (internal).

[11] Tremblay L. (2018). “CPG Standard Operating Procedure Breathing resistance (airflow resistance)”. RMC technical report (internal).

[12] Compeau S. (2014). SMPS, APS, and Data Merge Software, Version 4. RMC technical report (internal).

[13] TSI Inc. (2009). Series 3080 Electrostatic Classifier Operation and Service Manual.

[14] TSI Inc. (2007). Series 3775 Condenser Particle Counter Operation and Service Manual.

[15] TSI Inc. (2003). Model 3936 SMPS Instruction Manual.

[16] Kidd C., Véronique P., Finlayson-Pitts B.J. (2014). Surfactant-free latex spheres for size calibration of mobility particle sizers in atmospheric aerosol applications. Atmospheric Environment. 82: 56-59.

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[17] Vasiliou J. (2005). An Evaluation of a Scanning Mobility Particles Sizer with NIST-Traceable Particle Size Standards, NSTI-Nanotech. Conf. 2: 691-694.

[18] TSI Inc. (2015). Mask Integrity Test Accessory (MITA) Model 8120-Operator’s Manual P/N 6006153, Revision G.

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4 List of abbreviations and acronyms

AIM Aerosol Instrument Manager software (for SMPS and APS)

APS Aerodynamic Particle Sizer

CAF Canadian Armed Forces

CBRN Chemical Biological Radiological and Nuclear

CFR US Code of Federal Regulations

CPC Condensation Particle Counter

CPG CBRN Protection Group at RMC

DMA Differential Mobility Analyzer

DOP Dioctyl phthalate

DT Drinking tube

EC Electrostatic Classifier

EV Exhalation valve

HE High efficiency

HEPA High-efficiency particulate air

IL Inward Leakage

ISO International Organization for Standardization

L/min Litres per minute

MITA Mask Integrity Test Accessory

N A series of filters that are not oil resistant

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NIOSH National Institute for Occupational Safety and Health

P A series of filters that are oil resistant

P100 Highest particulate filter rating

RMC Royal Military College (of Canada)

SMPS Sizing Mobility Particle Analyzer

SOP Standard operating procedure

STP Standard Testing Procedure

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Air flow resistance Annex A

A.1 Purpose

The purpose of the following SOP is to describe a method to test the airflow resistance, or breathing resistance, of a given respirator, using NIOSH specifications.

The U.S. Code of Federal Regulations (CFR-2017 title 42 volume 1 section 84.180) [1] has requirements for airflow resistance for industrial respirators as follows:

(a) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a particulate respirator (complete respirator) mounted on a test fixture with air flowing at a continuous rate of 85 ±2 liters per minute, before each test conducted in accordance with 84.182 (Exhalation valve leakage test).

(b) The resistances for particulate respirators upon initial inhalation shall not exceed 35 mm water column height pressure and upon initial exhalation shall not exceed 25 mm water column height pressure.

The NIOSH CBRN full-face air purifying respirator standard [4] essentially uses the same method but with different associated requirements, not to exceed 65 mm water column inhalation and 20 mm water column exhalation.

A.2 Safety No special safety considerations are required.

A.3 Material requirements

A.3.1 Test equipment – Air flow resistance

The following equipment or equivalent will be used for testing air flow resistance at varying flow rates.

ISO headform (custom-built in-house at RMC) based on known anthropometrics [8].

A rubber silicon composite material is used to simulate a skin surface on the outside of the headform, providing a better sealing surface for the mask.

Headform mounted on breathing tube / head stand with integral sampling port

GAST blowers – Regenair, model R1102 x 1 to produce flow

Digital flow meter – TSI, model 4045, to measure flow

Needle valve – Swagelok, SS-12NRS12, to control flow

A P100 filter, such as SP3 Canister (3M Canada Brockville) or HE canister (Immediate Response Technologies), to protect the flow meter from particulate contamination

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Pressure sensor – Durham Instruments, Quantum X model MX840 with 1 psi pressure sensor, to measure air flow resistance (pressure drop at a given flow rate)

A.3.2 Test equipment – inward leakage The following equipment or equivalent will be used to assess the fit of the respirator to the headform prior to airflow resistance testing.

2-man tent or fixed chamber (ranging in size from 4 to 30 m3);

Sodium chloride (TSI) - geometric mean aerodynamic diameter of the aerosol between 0.1 and 0.3 μm, and geometric standard deviation less than 2.5;

2 to 8 TSI Particle Generators (Model 8026) to generate aerosol (>40,000 particles per cm3) and circulated with one, two or four fans inside the tent or chamber, depending on size of enclosure;

Condensation nucleus counting apparatus (TSI PortaCount Respirator Fit Tester 8030M, 8038 or 8020);

One with sample hose connected to the drinking tube of respirator being tested or to the sampling port of the breathing tube/head stand;

This same PortaCount is used to measure outside (challenge or ambient) concentration before and after sampling the respirator, as shown in Figure 3.

Alternatively, a separate PortaCount may be used to measure the challenge concentration simultaneously by placing a sample hose within the tent;

If two are used, the PortaCounts must read within 15% of each other and a correction factor for any remaining deviation obtained and applied;

The sampling line for the challenge aerosol contains a RMC custom capillary diluter (typically 15-25X dilution factor);

Custom RMC software CPG Protect 2016

Hygrometer with probe (e.g. Fisher Scientific, catalog number 11-661-19) to measure relative humidity and temperature.

All test instruments calibrated within 1 year.

ISO breathing headform (custom-built) based on known anthropometrics (see A.3.1)

Breathing machine (i-bodi Dynamic Breathing Machine-05, Crawley Creatures, UK).

The headform breathing waveforms were developed by RMC based on the ISO Standard work rates (Class 1-8) [9] and modified to conform to the sinusoidal breathing pattern produced by the breathing machine (Table 1).

Validated breathing machine waveforms using calibrated instruments (calibration within 1 year).

HE canister (Immediate Response Technologies): HEPA canister placed in line between the breathing machine and the headform to remove any particulates generated from the breathing machine.

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Table 1: Modified breathing machine rates programmed to give flow rates equivalent to Standard Breathing Rates for an ISO Standard Man [9].

BreathingClass Work Classification

Breathing machine program ISO16976-1

tidalvolume Frequency Peak

flow rate

No speech peak flow

rateL BPM L/min L/min

1 Resting 1.13 14 49.7 51 2 Light work 1.26 18 71.3 73.2 3 Moderate work 1.75 20 110.1 111 4 Heavy work 2.29 20 143.7 146.4 5 Very heavy work 2.52 22 174.2 177.6 6 Very, very heavy work (up to 2 h) 3.25 25 255.2 232.2

7 Extremely heavy work (up to 15 min) 3.72 26 304.2 268.2

8 Maximal work (up to 5 min) 4.25 28 374.2 325.8

A.4 Procedure

A.4.1 Airflow resistance testing setup

The airflow resistance testing apparatus configurations are illustrated in Figure 1 and Figure 2.

Figure 1: Configuration used for inhalation pressure drop testing.

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Figure 2: Configuration used for exhalation pressure drop testing.

A.4.2 Inward leakage testing setup

The test apparatus is shown in Figure 3. TSI generators generate salt aerosol within a tent or chamber to a concentration typically between 40,000-80,000 particles per cm3, geometric mean aerodynamic diameter of the aerosol between 0.1 and 0.3 μm, and geometric standard deviation less than 2.5. The challenge used is set to permit reliable measurement of PF at least 100,000 (concentration > 40,000 particles.cm-3).

The system is capable of measuring inward leakage (IL) of aerosol into the mask, from any source, of 0.00001 at the low end of the salt concentration specified above. The aerosol concentration within the

mask can be sampled from within the breathing tube/mouth of the headform (sampling port Figure 3), or from the drinking tube of the mask.

Figure 3: Test apparatus with breathing headform (single PortaCount configuration).

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A.4.3 Setup for both airflow resistance testing and inward leakage testing using dual-arm headstand

Figure 4: One possible setup for inhalation resistance testing with dual-arm headstand. The equipment in red on the upper arm of headstand diagram is used for IL testing and the remaining equipment connected

to the lower arm of headstand diagram is used for airflow resistance testing.

A.4.4 Experimental Procedure

1) Assure calibration of the digital flow meters (TSI, model 4045), pressure sensor (Durham Instruments), PortaCounts (TSI, model 8020 or 8030/8), and breathing machine waveforms. All calibrations must be valid at the time of testing.

2) Record test item tracking information and staff information.

3) Record all equipment information including identification numbers and calibration information.

4) Calculate dilution factor on the challenge concentration per standard operating procedure (SOP) [10].

5) Observe/record/photograph general condition of mask. Each mask is examined prior to testing to evaluate its condition before the test.

6) Set salt concentration (40,000-80,000 particles per cm3).

7) Perform baseline readings (no respirator) at specified flow rate before starting inhalation or exhalation testing on a given day using Catman software [11] . If all testing is not completed in a day, perform new baseline readings at the beginning of each day

8) Assemble canister to mask and place on headform. Examine to assure the face seal is properly seated and harness appropriately tightened. Photograph the sample on the headform.

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9) Using chosen headform size1: test inward leakage/protection factor. Breathing rate is set at class 2 while donning, and then set to class 8 for 4 breaths in order to blow out any particles that may be trapped in the respirator during donning. Inward leakage (IL) is assessed at breathing class 6. Acceptable IL is . 0.0022.

10) Once satisfactory IL is achieved for the respirator, the following tests may be performed using flow rates provided by the standard being used. Three respirators of each type, one set of readings per respirator, per the following:

i. For inhalation flow rate(s), pressure drop recorded (mm H2O);

ii. For exhalation flow rate(s), pressure drop recorded (mm H2O)..

11) After analysis, if any individual respirator pressure drop result lies outside 5% of the mean of the other two replicate respirators, if that value is low, the sealing of the mask to the headform will be supplemented and confirmed. If necessary, the entire test set for the respirator system under that set of conditions will be repeated once to confirm. The second data set will be taken as valid.

12) After 11) has been performed, if any mean pressure drop of the three respirators lies within 5% of the criterion, the entire test set for the respirator system under that set of conditions will be repeated once, and the two sets will be averaged to test against the criteria.

13) Record test item tracking information and any test item failures as well as any deviations from test protocol.

A.4.5 Analysis

Subtract baseline value from pressure drop reading for each test.

Obtain mean of each of 2 replicates of three total, difference of 3rd replicate from mean in each case. Average 3 replicates.

Calculate ratio of inhalation pressure drop to exhalation pressure drop (for each respirator). Mean of each of 2 replicates, difference of 3rd replicate from mean in each case. Average 3 replicates.

As calculations are performed, examine replicate pressure drop readings on each respirator type under each test condition for significant outliers or values close to pass/fail threshold. Repeat measurement as needed, and average replicates of the repeat set of data.

1 Headform size is chosen by performing this measurement on the first sample of a set of replicates, and changing size if required until satisfactory results are achieved. If necessary to achieve an adequate seal (sufficiently low inward leakage), a strippable caulking may be used around the outside seal of the mask. 2 This value is sufficient to assure that leakage around the face-seal will not reduce the inhalation breathing resistance. It is a generous inward leakage amount that should be capable of being met by any system that appropriately fits the population, given the standard anthropometry and pliable sealing surface of the headform.

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Efficiency test of non-powered air-purifying Annex Bparticulate filter

B.1 Purpose

The purpose of the following SOP is to describe a method to test the efficiency level of a new canister to ensure it meets standard P100 filtration levels (greater than 99.97% of a standard particulate challenge) by comparing the ambient particle count to the particle count post filtration. This experiment will be performed following standards set out in US Federal Regulation (42 CFR 84.181) [1] and in the standard procedure written by the National Institute for Occupational Safety and Health (NIOSH) [2].

All of the following information has been taken from Non-powered air-purifying particulate filtration efficiency level determination (42 CFR 84.181) [1].

Twenty filters of each non-powered air-purifying particulate respirator model are tested for filtration efficiency, as follows:

i. Filters are tested at a continuous airflow rate. The rate depends on whether there are 1 or 2 filters per mask.

a. For one filter, the test flow rate is 85 ± 4 liters per minute.

b. For 2 filters, the test flow rate is 42.5 ± 2 liters per minute through each filter.

ii. Filters are challenged with an aerosol concentration not exceeding 200 mg/m3 and testing continues until minimum efficiency is reached or until an aerosol mass of at least 200 ± 5 mg has contacted the filter.

iii. The minimum efficiency for each of the 20 filters is determined and recorded and must be equal to or greater than the filtration efficiency criterion listed for each level as follows:

P100, R100 and N100: Efficiency 99.97%

P99, R99 and N99: Efficiency 99%

P95, R95 and N95: Efficiency 95%

iv. For testing N-series filters:

a. Use a solid sodium chloride particulate aerosol as challenge. The aerosol is to have a particle size distribution with count median diameter of 0.075 ± 0.020 μm and a geometric standard deviation not exceeding 1.86.

b. 20 filters to be tested are taken out of their packaging and placed at 85 ± 5 percent relative humidity at 38 ± 2.5 ºC for 25 ± 1 hours. After pre-conditioning, filters are sealed in a gas-tight container and tested within 10 hours.

c. Test at 25 ± 5 ºC and relative humidity of 30 ± 10 percent.

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v. For testing P-series filters:

a. Use a dioctyl phthalate (DOP) or equivalent liquid particulate aerosol as challenge. The aerosol is to have a particle size distribution with count median diameter of 0.185 ± 0.020 μm and a standard geometric deviation not exceeding 1.60.

b. Test at 25 ± 5 ºC.

c. If the filtration efficiency is decreasing when the 200 ± 5 mg challenge point is reached, the test is to be continued until there is no further decrease in efficiency.

vi. Removable filters with gaskets are mounted on a test fixture in the manner as used on the respirator, including the gasket.

vii. Fixed filters that cannot be removed are tested with the exhalation valves blocked so that any leakage is not included in the filtration efficiency evaluation.

The above information was taken and cross-referenced with the relevant information from Determination of Particulate Filtration efficiency Level for P100 Series Filters Against Liquid Particulates for Non-Powered, Air-Purifying Respirators Standard Testing Procedure (STP) [2] to produce Table 2 which references the important parameters.

Table 2: Required parameters for method when using oil as test challenge.

Parameter/Specification Value

Temperature 25 ±5 ºC

Flow Rate 85±4 L/min

Particle Size (diameter) 0.185 μm

Concentration of Particle 200 mg/m³

Collected mass on Filter 200±5 mg *

Particle Geometric Distribution Max 1.60

Testing medium Dioctyl phthalate (or equivalent liquid particulate)

* If the filtration efficiency is decreasing once (an estimated) 200 mg has been reached, continue until efficiency levels out (no further decrease is seen).

B.2 Safety

The safety precautions pertinent to these types of experiment include:

Proper sealing of air chamber to ensure no particles are inhaled in by the people conducting the experiments

Ensuring all equipment is functional and up to standard before beginning the experiment.

When purging the chamber, use device constructed for that specific task, do not leave chamber open to lab.

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B.3 Material Requirements

Equipment

The following equipment is required:

2 Condensation nucleus counting apparatus (TSI PortaCount Respirator Fit Tester 8030M, 8038 or 8020)

1 digital flow meter (TSI model 4045)

1 needle valve

1 HE filter

1 filter mounting apparatus (constructed in-house), appropriate for filter/canister being tested

2 TSI particle generators (Model 8026)

Various length and size of tubing to connect all equipment

2 computers with CPG Protect software installed

1 RMC custom capillary diluter

1 GAST Blower, Regenair, model R1102

1 Hygrometer/Thermometer

1 Scanning Mobility Particle Sizer (SMPS) (TSI model 3936) – used to check aerosol particle size

Note that all this equipment (except the SMPS, TSI particle generators and hygrometer/thermometer) can be doubled if a second setup is needed.

Material

The following materials are required:

Emery Oil

B.4 General sequence of procedures

Prior to a measurement series, the general procedure to check and qualify the setup assures that (1) particulate concentration that will be achieved is appropriate for the requirement (which is set by mass concentration); (2) particle size distribution is appropriate; (3) filtration measurements on a standard filter achieve appropriate results. The actual filtration efficiency measurement follows once all performance parameters have been confirmed.

B.4.1 Equipment setup and procedure for particulate concentration determination

The equipment for comparing number concentration (as measured by the PortaCount) to mass concentration (as collected over a known time and air flow rate on a HE filter located within the Filter mount) is set up according to the diagram in Figure 5. Pictures of the general setup for concentration confirmation are presented in Figure 6.

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Figure 5: Block diagram of the concentration measurement apparatus.

Figure 6: Photographs of general setup for concentration experiment. a) overview of entire apparatus; b) GAST blower; c) needle valve and flowmeter; d) mounting apparatus in wall of chamber.

The test filter, which may be a pre-weighted HE filter for the concentration calibration portion of the activity, is mounted onto the mounting apparatus which is sealed to the outside of the chamber with the

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filter inside the chamber. The thermometer and particle generator(s) are located inside. The second HE filter captures any particles that were not caught on the test filter, protecting the flow meter.

Once the particle count (particles per cm3) as measured on the PortaCount has stabilized at a concentration up to 650,000 and 700,0003, the GAST blower is turned on and the flow rate is set using the needle valve and the digital flow meter, according to the flowrate required by the standard being followed. Following the US code of federal regulations (Table 2) the flow rate is set to 85 ±4 liters per minute. The start time is recorded. The initial temperature is also recorded making sure it is reading 25 ºC ± 5 ºC. The aerosol collection is left to run for at least 15 minutes. The GAST blower is then turned off, end time is recorded, and the test filter removed from the mounting apparatus. For the concentration determination portion of the activity, the test HE filter is re-weighed using the same balance, to the same number of significant figures.

All of the data is recorded on the Data Collection Sheet specific for this experiment (B.9). Using the mass data, the amount of particles (g) collected by the filter is calculated as follows:

This is mass is then used to calculate the concentration that was used to challenge that particular filter using the following equations:

Number concentration data are simultaneously collected using the PortaCount; the experiment is performed at several aerosol concentrations in order to permit correlation of the number concentration, which can be easily monitored during experiments, and the mass concentration of oil aerosol within the chamber (and which should be a linear relationship within an appropriate range of conditions). Using this defined relationship and a monitoring PortaCount during an experiment will ensure a sufficient concentration/mass of particles is used to challenge the test filters as well as confirm that the concentration in the chamber does not exceed the limit defined in the standard of 200 mg/m3.

B.4.2 Particle size distribution measurement

Before beginning the experimental series, the particle size distribution is confirmed to lie within the standard’s requirements at the aerosol oil concentration chosen for the test. The particle size is measured using a Scanning Mobility Particle Sizer (SMPS) and the SOP for this equipment is called “SMPS, APS, and Data Merge Software” [12].4

3 This is the maximum concentration that is obtained by using two generators running full. Higher concentrations are permissible but are not to exceed 200 mg/m3 (Table 2). 4 The SMPS particle size calibration can be checked using polystyrene latex spheres of known diameter, following the SOP found in B.8.

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B.4.3 Equipment setup and method for filtration efficiency

The setup for the filtration efficiency testing remains almost identical to that of the concentration determination other than the addition of a second PortaCount directly after the chosen test filter to measure the number concentration of particles not retained by the filter. This addition can be seen in the diagram in Figure 7.

The two PortaCount machines are chosen to respond similarly to one another as well as to a known reference PortaCount (that is within calibration) to ensure that they are giving correct and similar readings for ambient particle counts, as described in B.5.

Figure 7: Block diagram of measurement apparatus for filtration efficiency.

Figure 8 shows the new component added to the setup pictured in Figure 6 for the filtration efficiency experiment.

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a)

b) Figure 8: Photographs showing additional PortaCount required for percent efficiency experiment. a)

overview of entire setup; b) addition of a second (post filter) PortaCount.

For efficiency testing, the chamber is set to the appropriate particle count as determined in B.4.1. The new filter to be tested is quickly inserted into the chamber and testing can begin. The PortaCounts will be measuring both the ambient and post-filtration particle amounts for a duration that will guarantee a minimum of 200 mg has been collected (loaded) on the filter (based on the flow rate and mass-based concentration determined using the method in B.4.1).

According to regulation standard, if a P100 filter has decreased in efficiency once the challenge mass loading has been met, the test is to be continued until no further change in efficiency is observed. This can simply be monitored using the ratio of the two PortaCounts (chamber and filter).

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All data is recorded using the CPG Protect software and then transferred into a Microsoft Excel file where the following equation will be used to calculate percent efficiency per unit time to ensure percent efficiency is always met.5

Note that this percent efficiency value can be calculated for each time increment or simply for the entire data set by taking the average or each PortaCount reading over the duration of the experiment.

If percent efficiency is 99.97% at all times, the filter has passed. If less than 99.97% the filter has failed as per US federal regulations.

B.5 PortaCount Calibration

A supplier-calibrated PortaCount is used as a standard or reference apparatus to measure the function of all PortaCounts whose calibration has not been performed within one year. Every PortaCount should be connected (without diluters) to a chamber containing either oil or salt particles (depending on the function of the apparatus) as well as connected to a computer with the applicable software. The general setup can be seen in Figure 9.

Figure 9: Diagram of General PortaCount Calibration setup.

The particle counts will be measured on all PortaCounts simultaneously at four or more values below 100,000 (e.g. 10,000, 20,000, 40,000, 80,000) and then compared to the known reference reading checking for linearity.

5 Note that if two filter measurements are performed simultaneously using two PortaCounts, with a single PortaCount measuring challenge concentration, only a single dilution ratio can be entered into the software; however the two measuring PortaCounts will have different dilution ratios. Therefore one data set will need to be corrected in the Excel spreadsheet using the correct dilution ratio for the second PortaCount.

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All PortaCounts are started at the same time and data is recorded for 60 seconds at each of these intervals. This data is then taken and averaged. The average readings of uncalibrated PortaCounts are then plotted versus the reading of the known calibrated instrument. This should give a linear graph that can then be compared in percent difference from the calibrated results. If the instruments are comparable they are considered calibrated and clean.

B.6 Diluter

The diluter used before the chamber PortaCount (for either concentration determination or aerosol filtration efficiency), that reduces the concentration into the PortaCount’s linear response region – usually below about 80,000 particles/cm3 – should be regularly cleaned following the method described at the end of this section.

The diluter uses a capillary tube of a known length and diameter in parallel with a high efficiency filter to reduce the concentration of particles reaching the PortaCount (Figure 10 through Figure 14).

Figure 10: Capillary tube with end caps in place.

Figure 11: Label on the capillary tube container.

Figure 12: RMC custom diluter – side views.

Figure 13: RMC custom diluter – top view.

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Figure 14: RMC custom diluter – bottom view.

Each day, the dilution ratio provided by the combination of the diluter and the 2 PortaCounts is calculated before proceeding, as follows.

Connect both the chamber PortaCount (with diluter) and filter PortaCount (without diluter) to the chamber. While the chamber is filling with oil particulates, readings are taken for both PortaCounts simultaneously for 20 seconds. The concentration of particles in the chamber during these readings should not be less than 30,000 or exceed 80,000 particles per cm3. A dilution factor is then calculated as follows:

This dilution factor6 takes into account both the dilution ratio produced by the diluter and the correction for any difference between the readings of the 2 PortaCounts used. This parameter is entered into the CPG Protect software as the dilution ratio for the computer of the chamber PortaCount.

A clean diluter capillary tube will give a bench mark ratio the first time it is used. Since this ratio is checked daily, once it differs more than 10% from that bench mark, it should be cleaned following the steps below.

Step 1: Turn over the diluter and remove the two screws from the two slots using an Allen key.

Figure 15: Removing screws to open diluter.

Step 2: After removing the two screws disconnect the HEPA filter and pull the end block out of the diluter exposing the capillary tube.

6 If testing 2 filters simultaneously, a second dilution factor calculation will need to be completed using the chamber PortaCount and the filter PortaCount for the second filter system.

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Figure 16: Open diluter with exposed capillary tube.

Step 3: The long stainless steel capillary tube can now be removed from the Teflon fitting by gently pulling it out and then replacing it with a new capillary tube of the same dimensions.

Figure 17: Replacing the capillary tube.

Step 4: Fill a 30cc syringe with hot tap water and then connect the used capillary tube to the end of the tubing. Push about 150ml of warm/hot tap water through the capillary tube.

Figure 18: Rinsing the capillary tube.

Step 5: Fill the water reservoir of the model 50D ultrasonicator with warm/hot tap water about 1 inch from the top of the reservoir. The manufacturer DOES NOT recommend the use of Deionized or Reverse Osmosis water. (See operating manual). DO NOT run the sonicator dry.

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Figure 19: Ultrasonicator controls.

Step 6: It is important that the unit be pre-warmed for 10-15 minutes before you suspend the rinsed capillary tubes in the water. NB: DO NOT place items on the bottom of the reservoir. It is recommended that all sonicated items be suspended in the water during the sonication process.

Figure 20: Suspension of capillary tubes in ultrasonicator.

Step 7: After 30 minutes of sonication remove the capillary tube(s).

Step 8: Fill a 30cc syringe with warm/hot tap water and then connect the used capillary tube to the end of the tubing. Flush about 150ml of warm/hot tap water through the capillary tube.

Step 9: Using a can of compressed air….attach the tubing and capillary from the syringe to the end of the can of Dust off. Blow compressed air through the capillary for several minutes until no more water can be seen coming from the capillary tube.

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Figure 21: Drying the capillary tube.

Step 10: Reassemble the diluter and perform a dilution ratio test using either a salt or oil challenge.

Using the newest diluter design, with the VT10C3010 (1/16” x 0.030” x 10cm) capillary tube, yields a dilution factor on the order of 20. As the capillary tube clogs, the dilution ratio increases. If there is a leak, the value could be too low or too high, depending on where the leak is.

B.7 Green Line Filter Test

The same setup detailed in B.4.3 is used to test filters (TSI Green Line paper – part number 813010 – each lot number includes a “Penetration vs. Resistance graph”) of a known particle retention and efficiency at a specific pressure. The differences in this apparatus setup are the filter mounting apparatus that has been specifically constructed for Green Line filter testing and the addition of a pressure sensor attached post-filter. The change to the testing apparatus can be seen in Figure 22.

Figure 22: Diagram of Green Line filter testing setup with the added pressure sensor.

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First, two Green Line paper filters are cut using the custom made size specific cutter and placed on top of one another and attached to the custom-made holder with butterfly clips. The holder is also the mounting device which is the sealed into the chamber and tested. Penetration, flow rate and pressure drop are measured to evaluate the higher range penetration values. The test is then run a second time using the same two used filters with the addition of 3 new filters, for a total of 5 filters. The same measurements are recorded in order to evaluate the lower range penetration values.

The percent penetration (inverse of percent efficiency) and the average pressure during each trial are compared to the information provided on the “Penetration vs. Resistance graph” which is specific to each lot number of Green Line paper and provided for both the 2 and 5 filter thicknesses.

If both sets of data fall within accepted range, testing for that series can continue. This process is to be repeated for each project.

B.8 Scanning Mobility Particle Sizer calibration

B.8.1 Purpose

The purpose of this method is to determine the accuracy of particle size separation performed by the Scanning Mobility Particle Sizer (SMPS) using polystyrene latex microspheres of known size.

B.8.2 Safety

General safety features pertinent to the SMPS are outlined in the Series 3080 Electrostatic Classifier Operation and Service Manual [13], Series 3775 Condensation Particle Counter Operation and Service Manual [14]and Model 3936 SMPS Instruction Manual [15].

The 3080 Electrostatic Classifier (EC) contains an aerosol neutralizer with a Krypton-85 source. The neutralizer has a half-life of 10.4 years. Care must be taken when installing or removing the neutralizer following the instructions in the manual [13].

A dosimeter should be worn when working with the SMPS.

B.8.3 Material

Equipment

1 Model 3080 Electrostatic Classifier (EC) – TSI

1 Model 3775 Condensation Particle Counter (CPC) – TSI

1 C700d PFA Concentric Nebulizer – Savillex

1 Model 3062 Diffusion Dryer – TSI

1 Retort stand and clamp

Material

Ultrapure air

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Polystyrene microspheres within range of particle separation

0.10 micron – Alfa Aesar

0.50 micron – Alfa Aesar

15 ml plastic dropper bottles

Ultrapure water/ Milli Q water

B.8.4 Procedure

Set up the equipment following the schematic shown in Figure 23.

Figure 23: Schematic of the SMPS calibration setup.

Use Teflon tubing as aerosol particles will be more likely to attach to other types of plastic due to static charge.

The SMPS should be pre-assembled and will only need to be connected to the diffusion dryer.

Check the overall pressure of the ultrapure air cylinder. If too low (below 50 psi), cylinder must be replaced as particle contamination may occur. Set regulator to 30 psi for the experiment.

Check the colour of the silica within the diffusion dryer, if 50% of the silica is purple then it must be dried or replaced.

Turn on both EC and CPC to warm up.

To follow the warm-up, select status under the menu tab on CPC. Parameters shown in red are not ready. Until all parameters are ready, the top border of the status window will be red and will read “Status: Multiple Errors” (Figure 24 left). Any tests performed at this time will not be accurate.

When the system is warmed up and ready to be used the top bar will be green and will read “Status: Normal” (Figure 24 right).

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Figure 24: Example of status screen showing errors during warming up of CPC (left); example of status

screen showing a ready CPC (right).

Figure 25: Photograph of the calibration setup, not including the SMPS. Note that the stirrer and cork ring are only used to raise and support the sample bottle.

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Figure 26: Photograph of the SMPS.

B.8.4.1 Preparation

Rinse the sample containers (15 mL plastic dropper or other desired container) using deionized water three times, followed by three times with ultrapure water.

Fill the sample containers with approximately 15 mL of ultrapure water.

If testing microspheres ranging from 0.1-0.3 μm, 3 drops (~150 μL) of the microspheres are placed into the container [16].

Microspheres greater than 0.3 μm require 6 drops (~300 μL) [16].

Sonicate samples for 5 min (no heat) before running test to reduce aggregation and excessive background.

It is not necessary to stir or mix the microsphere sample during testing.

One bottle, containing only ultrapure water, is used before and after each microsphere size sample so the nebulizer and SMPS can be flushed of previous sample.

To purge the system, ultrapure air (set at 30 psi) is run with ultrapure water as sample to ensure no carryover and to remove any air bubbles within the nebulizer solution line. (The EC pump is running constantly so it will draw the air through the system.) After 5 minutes, the SMPS is set to sample (3 sets of 3) following the same procedure as for the microspheres (see B.8.4.2 below) in order to confirm cleanliness.

Between runs, drain excess solution from the diffusion dryer water collector that has been collected from nebulizer (Figure 27).

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Figure 27: Diffusion dryer water collector and purple silica within the diffusion dryer.

B.8.4.2 Setting up the software/run

Open Aerosol Inventory Manager (AIM) software to set up the run (only when CPC is ready). Click new file (paper icon at the top left hand corner) and name file with as much detail as possible. (Example: 30 psi ultrapure air, 3 drops of 0.1 micron spheres in ultrapure water through nebulizer and air diffusion dryer).

Figure 28: Starting new run on AIM software. New file is circled in red.

Check that the file type is set to *.S80 (Figure 29). Other file types will not account for the size of the particles and will only take in particle concentration obtained from CPC.

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Figure 29: Confirmation of file type for running the SMPS.

Open the named file and the SMPS properties window will open up (Figure 30). Most of the properties of the run are already pre-set and not much has to be changed but it is best to double check that they are correct.

CPC Model and Flow rate 3775 low Classifier Model 3080, Auto-connect DMA 3081 DMA Flow Rate Sheath 3.00

Aerosol 0.30 Optional bypass flow 0.0 Impactor Type 0.071 (Figure 31)

Impactor type is pre-set to none and must set to the impactor that is being used. Can check which impactor is installed at the front of the EC. For Size Range Bounds, select Set to Max Range.

The aerosol flow of the CPC can be changed to either high (1.5 L/min) or low (0.3 L/min) based on the method therefore must change to the corresponding flow rate in the software or it will revert back to previous settings. If the high flow rate is used for the CPC, the sheath flow rate of the EC must be set to 15 L/min (10 times the flow rate of the CPC) as it is dictated by the SMPS used manual for optimal results [3]. For this testing the Aerosol flow rate to be used is 0.3L/min with corresponding sheath flow of 3.00L/min.

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Figure 30: Hardware settings on the SMPS properties window.

Figure 31: Image of impactor location and label.

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Once hardware settings have been confirmed, select the scheduling tab (Figure 32).

Figure 32: Scheduling tab on the SMPS properties window.

Each scan is set to take 135secs which consists of 120 secs for upscan and 15 secs for downscan.

To perform testing in triplicate, type 3 in the Number of Samples box and 1 in the Scans per Sample box. This will give 3 individual graphs and data sets.

Alternatively, if 3 Scans per Sample is entered and only 1 sample, it will average the 3 scans and give only 1 data set and graph. The number entered under Scans per Sample defines the ‘Sample’ size.

For this testing, select 3 Scans per Sample and 3 Samples overall which gives 9 scans total (takes about 20min). This will produce 3 sets of graphs and data with 3 scans averaged in each set from the same physical sample solution

Press ok when ready and 4 windows will open up (Figure 33). Press green button to start run.

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Figure 33: 4 different windows of AIM software. First window top left is the size data graph, window top right is size data table (raw data), bottom left is the sample list and bottom right is the statistics table.

Data collection and interpretation

Obtain the data from AIM software which can be found on the 4th window at the bottom right.

Figure 34: Finished run of a 0.1 micron sphere sample showing a highest sample peak at 0.947 micron diameter seen in the size data graph window and in the mode row in the statistics table window.

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Multiple peaks or high background may occur due to trace amounts of ions still present in ultrapure water that may produce particles. The presence of surfactant in microsphere samples is due to manufacturing packaging where it is added to reduce aggregation of microspheres. Surfactant particles may be detected by the EC. This problem can be overcome by using a cleaning procedure by Vasiliou, 2005 [17].

Select the peak closest to the microsphere size and compare the mode value under Diameter Particle Size in the Statistics Table (Figure 34) with the certificate of authenticity of the microspheres found either on the manufacturing website or within the packaging.

B.9 Data Collection Sheet

Checklist PortaCount calibration: YES NO Green line filter test (once daily): YES NO Particle size confirmed? YES NO Filter Seal Checked: YES NO Chamber Seal Checked: YES NO Dilution Ratio: Additional information about above checklist items: Specific Equipment Used: Equipment Type CPG ID / serial number

Generator

PortaCount (1)

PortaCount (2)

Digital Flow Rate apparatus

Needle Valve

Balance

Date

Time

Operator

Trial/Filter number

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Parameters

Observations During: After: Concentration Calculation:

Temperature / °C

Flow Rate (L/min)

Initial Particle Count Chamber (particles/cm3)

Final Particle Count Chamber(particles/cm3)

Initial Particle Count After Filter(particles/cm3)

Final Particle Count After Filter(particles/cm3)

Initial Filter Mass (g)

Final Filter Mass(g)

Time Run (min)

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Exhalation Valve Leakage in a Non-Powered Air-Annex CPurifying Respirator.

C.1 Purpose

The purpose of this Standard Operating Procedure (SOP) is to determine a method of testing exhalation valve leakage in a non-powered air-purifying respirator, the standards for which are set out in US Code of Federal Regulations (42 CFR 84.182) [1] and in the standard procedure written by the National Institute for Occupational Safety and Health (NIOSH) [3]. Dry exhalation valves and valve seats are to be subjected to suction of 25 mm water column height and leakage between the valve and the valve seat must not exceed 30 mL/minute.

C.2 Safety

General safety features pertinent to the Mask Integrity Test Accessory are outlined in the Operators Manual [18]. Other safety features include prevention of inhalation of generated Emery Oil particulates and ensuring all equipment is in proper working condition.

C.3 Material

Equipment

1 Mask Integrity Test Accessory (MITA)

1 Exhalation Valve Adapter

1 PortaCount Plus (8020)

Material

Emery Oil – TSI Inc.

C.4 Procedure

First, the MITA is setup and unpacked as per the instruction manual provided with the instrument and the PortaCount is attached via the connecting cables provided with the MITA [18]. Figure 35 shows the general setup without a respirator connected.

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Figure 35: Face-on and aerial view on MITA apparatus and close up of exhalation valve adapters, where A – PortaCount apparatus; B – MITA Headform; C – MITA module/screen; D – Exhalation Valve

Adapters.

The MITA is then run through the Self Check application. The on-screen prompts will direct the user through each verification. The Self Check verifies the following parameters: Drink Tube Restriction Calibration, DP1-DP3 Compare, DT Flow/Mask Flow Compare, DT Leak Zero Test, EV Leak Zero Test, EV Hose Blockage Test and, Protection Factor Test (terminology is explained in the instrument manual [18]). If even one of these parameters does not meet standards the Self Check has failed and

D

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calibration/troubleshooting should be done. If Self Check has passed, testing is valid for the following 24 hour period.

When setting up for exhalation valve only testing the first time, from the Settings menu open the Define Mask Protocol tab and enter the password (located in the manual). Disable both Drink Tube (DT) test and Protection Factor (PF) test. Leave Exhalation Valve (EV) test enabled. Under Name Protocol, enter a name for the new exhalation valve test protocol. Select Save & Exit to save the name. Next select EV Test Parameters and set Exhalation Valve Leak (allowable leakage rate in sccm) and Exhalation Valve Test Press (pressure to be used for testing in inches of water). The next time when performing the same type of testing go to the Settings menu and open the Select Mask Protocol tab and then select the exhalation valve protocol required.

The EV testing is then ready to begin. The respirator is connected to the MITA via the exhalation valve/exhalation valve adapter (provided with the MITA (TSI Inc.) or manufactured in-house). The Test Mask function is selected from the main menu and the system will prompt the user to check the connection of the mask to the EV adapter. The user then presses the “next” soft key and the test will begin.

The leakage flow indicated is recorded once the system has finished testing. This procedure is repeated three times for each valve on a respirator. The average of these three flow values is calculated and reported.

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DOCUMENT CONTROL DATA *Security markings for the title, authors, abstract and keywords must be entered when the document is sensitive

1. ORIGINATOR (Name and address of the organization preparing the document. A DRDC Centre sponsoring a contractor's report, or tasking agency, is entered in Section 8.)

c/o Royal Military College of Canada Dept. of Chemistry & Chemical Engineering PO Box 17000 Station Forces Kingston ON K7K 7B4 Calian Technologies 340 Legget Dr Ste 101 Ottawa ON K2K 1Y6

2a. SECURITY MARKING (Overall security marking of the document including special supplemental markings if applicable.)

CAN UNCLASSIFIED

2b. CONTROLLED GOODS

NON-CONTROLLED GOODS DMC A

3. TITLE (The document title and sub-title as indicated on the title page.) Standard Testing Methods for Various Respirator Functions

4. AUTHORS (Last name, followed by initials – ranks, titles, etc., not to be used) Tremblay, L.; Laidlaw, N.; Ho, T.

5. DATE OF PUBLICATION (Month and year of publication of document.) March 2019

6a. NO. OF PAGES (Total pages, including Annexes, excluding DCD, covering and verso pages.)

48

6b. NO. OF REFS (Total references cited.)

18 7. DOCUMENT CATEGORY (e.g., Scientific Report, Contract Report, Scientific Letter.)

Contract Report

8. SPONSORING CENTRE (The name and address of the department project office or laboratory sponsoring the research and development.) DRDC – Suffield Research Centre Defence Research and Development Canada P.O. Box 4000, Station Main Medicine Hat, Alberta T1A 8K6 Canada

9a. PROJECT OR GRANT NO. (If appropriate, the applicable research and development project or grant number under which the document was written. Please specify whether project or grant.)

Project 001 to #2018-020-SLA RMC-

SOFCOM

9b. CONTRACT NO. (If appropriate, the applicable number under which the document was written.)

W0046-19-131

10a. DRDC PUBLICATION NUMBER (The official document number by which the document is identified by the originating activity. This number must be unique to this document.) DRDC-RDDC-2019-C142

10b. OTHER DOCUMENT NO(s). (Any other numbers which may be assigned this document either by the originator or by the sponsor.) RMC TR CPT-1901

11a. FUTURE DISTRIBUTION WITHIN CANADA (Approval for further dissemination of the document. Security classification must also be considered.)

Public release

11b. FUTURE DISTRIBUTION OUTSIDE CANADA (Approval for further dissemination of the document. Security classification must also be considered.)

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12. KEYWORDS, DESCRIPTORS or IDENTIFIERS (Use semi-colon as a delimiter.)

performance testing; test method; respirator 13. ABSTRACT/RÉSUMÉ (When available in the document, the French version of the abstract must be included here.)

The Royal Military College of Canada (RMC) is a test centre for respirator testing for the Canadian Armed Forces (CAF). This Contract Report presents the procedures developed and performed by RMC, as directed by Defence Research and Development Canada, to test protective respiratory devices according to selected standards set out in US Federal Regulation 42 CFR 84 and by the National Institute for Occupational Safety and Health for air flow resistance, particulate filtration efficiency, and exhalation valve leakage. Le Collège militaire royal du Canada (CMR) est un centre d’essai de respirateurs pour les Forces armées canadiennes (FAC). Le présent rapport présente les procédures élaborées et appliquées par le CMR, comme prescrit par Recherche et développement pour la défense Canada, pour tester les dispositifs respiratoires de protection conformément aux normes choisies établies dans le titre 42, partie 84 du Code of Federal Regulations et par le National Institute for Occupational Safety and Health pour la résistance au débit d’air, l’efficacité de la filtration des particules et la non-étanchéité de la soupape d’expiration.