Respirators are mainly of two types – air filtering and air-supplying. The former type of respirator such as an N95 respirator or mask prevents bacteria, contaminants, and other particles from entering your nose and mouth. The latter one supplies the user with clean air from a tank or other clean source such as an SCBA. Due to the global COVID-19 pandemic, there is an increasing demand for N95 masks or respirators amongst healthcare workers across the USA as they are dealing with acute shortages while treating COVID-19 infected patients. N95 masks suppliers in the USA have accelerated their production process to meet the rising demand for N95 respirators. In this article, we will discuss how N95 masks manufacturers make N95 masks, and how they are tested.
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What Are N95 Respirators?
N95 respirators were originally developed for industrial apps. These are specifically designed masks that filter out at least 95% of particles beyond .3 microns. There are even N99 and N100 respirators; N100 blocks at least 99.97% of particles from reaching your nose and mouth. Genuine surgical masks are approved and authorized by both the FDA and NIOSH (the National Institute for Occupational Safety and Health). N95 respirators are available in various shapes, which can help the healthcare workforce with finding the perfect size for their faces. Some N95 masks come with exhalation valves, which allow wearers to breathe comfortably.
It’s worth noting that not all N95 masks are created for medical applications; some are designed for industrial use. As one of the leading bulk PPE suppliers in the USA, we offer a vast network of N95 masks suppliers in the USA that provide N95 masks online for medical applications.
Medical N95 respirators are one-time use products regulated as class II products under the FDA (Food and Drug Administration) and NIOSH (the National Institute for Occupational Safety and Health).
Also, according to the latest reports from Healthline and the CDC, masks with valves or vents are more likely to spread infection. Although this type of mask provides the same protection for the wearer as an unvented face mask, however, the valve does not stop viruses from coming out. This can enable individuals who are unaware that they are infected to spread the virus to others. Also, a face shield without a mask contributes to the spreading of the virus.
How N95 Masks Work?
N95 masks filter out particles because of the structure of their nonwoven material. Contaminated particles are trapped as they are compelled to make twists and turns through the compact network of the material’s fibers which are thin like a micron. Masks also come with electrostatically charged material to attract particles. As contaminated particles build up, the mask turns out to be the more efficient filter. But, the buildup also makes the mask more unbreathable. This is why the masks and filters are made for one-time use.
How to Make N95 Respirators?
A medical N95 respirator contains different layers of nonwoven fabric, usually made from polypropylene. The two outer protective layers of fabric, which cover the inside and outside of the mask, are made using spun bonding. Spun bonding makes use of the thermoplastic polymer’s (often polypropylene) nozzles blowing melted threads to layer threads between 15-35 micrometers on a conveyor belt, which creates a cloth as the belt goes down the line.
N95 masks manufacturers then bind the fibers using thermal, chemical, or mechanical techniques. The two external layers of the respirator, between 20 and 50 g/m2 in density, act as solid protection against the external environment and a blockage to anything the wearer exhales out.
In between the spun bond layers, there is a pre-filtration layer, which can be as dense as 250 g/m2, and the filtration layer. The pre-filtration layer is typically a needled nonwoven material. The nonwoven material is needle-punched to enhance its cohesiveness, which is achieved by sending barbed needles repetitively through the fabric to hold fibers together. The pre-filtration layer then undergoes a hot calendaring process, where plastic fibers are thermally bonded by making them run through high-pressure heated rolls. This makes the pre-filtration layer strong and thicker. So, it can be molded easily in the desired shape and remain in that shape when the mask is in use.
So, this is the overall process followed by N95 mask manufacturers in the USA to produce robust, durable, and highly effective N95 masks for the wearers.
How N95 Masks Are Tested?
Just like surgical masks, N95 respirators undergo various tests to ensure their effectiveness. You can learn more about the tests on the official CDC website. However, we will be giving a brief overview. At the CDC, N95 masks are acclimatized for a day (24 hours) before testing by keeping them in a 38⁰C environment with 85% comparative humidity.
During the testing process, the ability of the respirator filtration must be always above its certification class level. N95 respirators are tested with:
- Charged neutralized sodium chloride aerosol spray that contains particles with an average of .3 micron in diameter. This is done for testing particle penetration.
- An airflow of 85L every minute to test a moderately high work rate.
- A breathing resistance testing is done at 35 millimeters or below water column height pressure, and exhalation resistance testing is performed at 25 millimeters or below water column height pressure. A millimeter of water column height pressure refers to the pressure from 1mm of water at 39⁰F.
- A minimum of 200 mg of aerosol loading simulates a greater level of exposure by blocking the mask with aerosol particles.
N95s are also tested for fluid resistance, flammability, biocompatibility, and particulate and bacteria filtration by the FDA. When N95 masks manufacturers in the USA make these masks, they are required to get them approved from both the FDA and NIOSH (the National Institute for Occupational Safety and Health).
However, due to the ongoing pandemic, NIOSH-approved N95 respirators not regulated by the FDA, for example, the ones used in industrial settings, can now be used by healthcare workers. You may refer to the official CDC website for more information on the NIOSH approval process and N95 respirator tests and methods.
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Final Note
In this guide, we have discussed everything on how to make N95 respirators and how they are tested. The CDC also provides recommendations and guidelines for expanding the supply of N95 masks. If you are one of the N95 masks manufacturers in the USA and want to source N95 respirators, you may contact us and join our vast network of bulk PPE suppliers in the USA.
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