Technical Questions

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What are the 9 types of Filtering Facepiece Particulate Respirators?

NIOSH certifies 3 types of disposable particulate filters with 3 levels of filter efficiency (95%, 99% and 99.97%) in each class. All filters are tested by utilizing the most penetrating aerosol size 0.3 micron (aerodynamic mass median diameter).

N-series (Not resistant to oils) - tested against a mildly degrading aerosol of sodium chloride (NaCl) and provides effective filtration of aerosol particulates free of oils

N95 - Filters at least 95% of airborne particles. Not resistant to oil
N99 - Filters at least 99% of airborne particles  Not resistant to oil
N100 - Filters at least 99.97% of airborne particles.  Not resistant to oil

R-series (somewhat Resistant to oil) - tested against a highly degrading aerosol dioctytphalate (DOP) and provides “somewhat” effective filtration of oil-mist aerosol particulates

R95 - Filters at least 95% of airborne particles. Somewhat resistant to oil
R99 - Filters at least 99% of airborne particles  Somewhat resistant to oil
R100 - Filters at least 99.97% of airborne particles.  Somewhat resistant to oil
 
P-series (strongly resistant oil Proof) - tested against a highly degrading aerosol dioctytphalate (DOP) and provides effective filtration of particulates in an oil-mist/ aerosol 

P95 - Filters at least 95% of airborne particles. Strongly resistant to oil
P99 - Filters at least 99% of airborne particles  Strongly resistant to oil
P100 - Filters at least 99.97% of airborne particles.  Strongly resistant to oil

 

Are all Filtering Facepiece Particulate Respirators one-size-fits-all?

No. There are two classifications of respirators that are designed and constructed to fit users with various facial shapes and sizes: 

Group 1 – Respirators where multiple sizes (small, medium & large) are used to ensure that the respirator will fit a panel of test subjects of various facial sizes and shapes. 

Group 2 – Respirators where a single size (one-size-fits-all) is used to ensure that the respirator will fit a panel of test subjects of various facial sizes and shapes.

The National Personal Protective Technology Laboratory (NPPTL), Technical Evaluation Branch has developed criteria that must be met in order to be approved for the one-size-fits-all classification.  The NPPTL employs a test panel of 10 subjects with varying facial sizes and shapes classified from size 1 through 10.  This is called the Los Alamos National Laboratory (LANL) panel.  Each of the 10 subjects, on 2 separate occasions, is fit-tested in a corn oil atmosphere to test the seal between the respirator and the face (the face-seal).  Using the OSHA protocol for Portacount fit-testing, the subjects must collectively pass at least 95% (19 out of 20) of the total trials with an overall fit factor greater than or equal to 100. 

Fitseal Respirators have an overall fit factor greater than or equal to 100 and are approved by NIOSH for one-size-fits-all. 

 

What is the difference between an N95 & N99 respirator?

The N95 designation means that the filter medium has a filtration efficiency of at least 95% (i.e. will allow no more than 5% particle penetration) against particles that are 0.3 microns in size.  This means that up to 5 out of every 100 airborne particles can penetrate the filter medium and enter the wearer’s breathing zone.

The N99 designation means that the filter medium has a filtration efficiency of at least 99% (i.e. will allow no more than 1% particle penetration) against particles that are 0.3 microns in size. This means that up to 1 out of every 100 airborne particles can penetrate the filter medium and enter the wearer’s breathing zone. 

It is important to note that while the filter itself will provide certain protection efficiency (95% or 99%) there are other potential sources of particle inward leakage of particles that can reduce a respirators effectiveness. These include:

 

What is the major difference between an adhesion respirator and a conventional respirator that is held in place by straps, rubber bands and nose clips?

A triumph of science and technology, and the result of 5 years of extensive R & D by leading aerosol scientists and medical professionals in Canada and the US, Fitseal strapless adhesion respirators provide unsurpassed respiratory protection, comfort and breathability.
Made with state-of-the-art filtration media, Fitseal utilizes a medical-grade, hypo-allergenic, latex-free adhesion strip to secure the respirator to the face instead of straps, rubber bands or nose clips.  Fitseal is approved by NIOSH for ONE-SIZE-FITS-ALL and conforms to the contours of your face providing a proper fit and a secure seal, virtually eliminating gaps around the edge of the respirator that can allow inward leakage of harmful airborne viruses, bacteria and toxic particles that can get in to your lungs. If the masks leaks, harmful particles can enter the breathing zone, and your health can be compromised.

 

How important is the Face-seal?

Aerosol studies have concluded that particle penetration through gaps between the respirator and the face (the face-seal) can account for over ten times more harmful and toxic particles entering the breathing zone than through the filter media itself.  An integral and effective face-seal is extremely important, particularly with exposure to infectious pathogens such as viruses and bacteria. If the respirator facepiece does not seal properly to the face, harmful airborne pathogens can enter the wearer’s breathing zone.

 

What is Fit-Testing?

OSHA mandates fit-testing to ensure that the correct brand/model/size respirator “fits” the wearer’s facial contours.

 

There are two methods for fit-testing.

Qualitative:  The qualitative test is a pass/fail that relies on the individual tasting, or not, an administered ambient irritant such as isoamyl acetate (banana oil), smoke, or saccharin or denatonium benzoate(Bitrex¬Æ).
 
Quantitative:  The quantitative test assesses the integrity of the fit (faceseal) by measuring the ratio of an indicator outside and inside the facepiece. 

In both cases, a trained technician monitors each individual as they perform numerous maneuvers that imitate work routines.  The fit-test procedures are outlined in OSHA Fit-Testing Procedures – 1910.134 Appendix A.

 

Do Fitseal™ Respirators require fit-testing?

Yes.  In the U.S. and Canada, OSHA regulations mandate fit-testing for all respirators. Although Fitseal respirators have been approved by NIOSH for one-size-fits-all, they are not exempt from fit-testing.

 

Why do Fitseal™ Respirators simplify fit-testing procedures?

Fitseal respirators have been approved by NIOSH for one-size-fits-all; fitting a range of facial sizes and shapes from 1 to 10 (one subject from each box of the Los Alamos National Laboratory panel).  As such, they will “fit” the vast majority of individuals on the first attempt, reducing mask wastage and lost time spent testing and re-tested.  In addition, changes to a user’s facial size due to weight gain/loss or pregnancy will not require re-testing (except as mandated by legislation).

 

What is a User Seal-Check?

The user seal check is done by the wearer each and every time after donning a respirator in order to assure that there are no leaks between the respirator and the face (the face-seal).  The user seal check in and of itself does not obviate the fit-test outlined above.

To ensure a secure respirator-to-face seal, the user seal check consists of breathing in and out forcefully. The top layer of the respirator should billow out slightly on exhalation and collapse inwards on inhalation, indicating that the respirator has a protective seal.  Leaks may be detected on breathing in by a slight coolness on the skin at the respirator/skin interface.  If leaks are detected, press firmly around the circumference of the Fitseal respirator and then repeat the user seal check.

 

What is the Fit Factor (FF)?

The Fit Factor (FF) is a numerical measure of an aerosol challenge expressed as the ratio of the aerosol’s concentration outside the respirator divided by the concentration that penetrated and leaked to the inside during the respirator fit-test procedure(s).

 

What is the Assigned Protection Factor (APF)?

The Assigned Protection Factor (APF) is the level of protection that a particular type of respirator is expected to provide 95% of the time it is used. An APF of 10 means that a properly fitted respirator can be safely used in an atmosphere that has a concentration up to 10 times the Permissible Exposure Limit (PEL) for the particular hazardous agent. The APF values are assigned by U.S. National Standards Organizations such as NIOSH and ANSI.

It is customary practice to use ten times the APF as the Fit Factor pass level when doing quantitative fit testing.  Fitseal Respirators exceed the minimum pass level requirements.

 

What is Total Inward Leakage (TIL)?

TIL is the measurement of all routes of particle penetration.  This includes particle penetration via;
- through the filter material,
- through exhalation valves,
through holes from staples and grommets that attach the straps and rubber bands to the respirator, and through gaps between the respirator and the face (the face-seal). 

“The inward leakage of a respirator is determined by measuring the concentration of a challenge aerosol outside of the respirator, as well as the concentration within the breathing zone.  Respirator fit testing normally considers face-seal leakage.  Total inward leakage defines a protective level achieved by a respirator when the contributions of all leakage paths are considered.  The TIL is defined as the ratio of the external concentrations to the breathing-zone considered.” Quoted from the NIOSH Total Inward Leakage Project, October 31, 2007 by Roland Berry Ann.

 

What types of particles are Fitseal™ Respirators effective against?

The Fitseal respirators are effective, consistent with their respective NIOSH approvals, against any and all particles.  Some examples include:

Are Fitseal™ Respirators effective against Pandemic Flu?

Yes.  Any “flu” virus is a particle, and risk of exposure can be significantly reduced by wearing the Fitseal respirators.  The adhesion seal and bi-lateral filtration media helps to protect the user and those around them from contracting or transmitting the flu virus.  By minimizing the gaps between the respirator and the face, (the face-seal) the likelihood of further transmission is significantly reduced. 

 

Do Fitseal™ respirators provide protection for asbestos particles?

Yes. According to Ontario Regulations under the Occupational Health and Safety Act, as long as the concentrations are less than or equal to 10 fibers per cm3, (per Ontario OHSA),a disposable filtering facepiece respirator can be used.

 

Do Fitseal™ respirators provide protection against M.tuberculosis and influenza?

Yes.  Air-purifying filtering facepiece particulate respirators approved by NIOSH as per 42 CFR Part 84 meet or exceed the CDC filtration efficiency performance criteria. The NIOSH approved Fitseal Respirators meet the CDC guidelines for use when exposed to M. tuberculosis.

 

What Size Particles do Fitseal™ Respirators filter out?

Airborne particles that are considered respiratory hazards range in sizes between 0.01 to 100 micrometers (µm). Fitseal Respirators have been tested and proven to filter out such particles with at least 99% efficiency. The established standard for filtration (penetration) is based on testing with particles of 0.3 microns mass median aerodynamic diameter as per criteria in 42 CFR Part 84. The particle diameter of 0.3 µm is used because it is the size most likely to penetrate the filter medium. Particles of both smaller and larger diameters will be trapped with even greater efficiency due to the electrostatic and mechanical properties of the filter.