CATER Mask Decisions

November 24, 2020

Millions of Lives Saved with Intelligent Mask Program

Millions of Lives at Risk

Billions of Masks Needed to Achieve Herd Immunity

Electrospun Nanofibers Available for CATE Masks

4C Air Supplies Nanofiber Based Masks for $3 Each

Dipole Providing Nanofiber Media for Military Protection

Dipole Teaming with Gemstone Bio on Nanofiber Media for Masks

Bionicia Supplies Electrospinning Equipment and Does Contract Manufacturing

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Millions of Lives Saved with Intelligent Mask Program

More than 55 million people have contracted COVID-19 globally and 1.3 million​ have died. More than 3 million more people will die in the next 13 months unless policies change.

Many of these of lives can be saved by an intelligent mask program. Acceleration of the use of 93% rated CATE masks combined with decreasing use of 49% rated CATE masks and restrictions against 20% rated CATE masks are what is needed. A combination of vaccines and masks can provide the equivalent of herd immunity (70%) by July of next year.

Experts are unanimous in their belief that masks can save millions of lives in the next 13 months. But this is like saying that drugs can save millions of lives. This statement may be true but only if the right masks are worn. Some masks provide no protection. The belief that these masks capture large cough and sneeze droplets is valid but there are two big problems.

·         Most virus is transmitted in small droplets through breathing and talking

·         Large droplets temporarily captured evaporate and transmit the virus on a delayed basis

The idea that all masks are created equal has been as responsible for infections as the idea that masks are not important or that mandates unfairly violate civil rights. It is therefore imperative that the public understand differences between masks and wear ones which provide protection as well as reduce transmission.

There are four aspects of masks which are important.

·         Comfort: People will not wear masks all day if they are not comfortable.

·         Attractiveness:  As a major article of clothing an attractive mask will be used more than an unattractive one.

·         Tight Fit:  It is very difficult to achieve a tight. But if 50% of the air leaks around the mask 50% of the virus will as well.

·         Efficiency: Many masks claim high removal efficiency on viruses which are the size of perfume or smoke. But unless valid performance tests are available the efficiency is questionable.

These four important aspects form an acronym. CATE masks are what every person will want to have. There are many reusable versions of CATE masks which make them affordable even it the initial price is 30 times that of a disposable mask.

If everyone were to start wearing masks with a 93% CATE rating tomorrow most of the transmission would stop and millions of lives would be saved. This may not be possible immediately. But within six months everyone could have 93% rated CATE masks.  In the meantime there are sufficient 49% rated CATE masks to be used where the 93% rated masks are not available. It will be equally important to warn people against using masks with a rating below 20%. They provide access to restricted areas and therefore result in more infections than if they were not available

So governments who are already mandating masks have to clarify  their policies. They should provide guidance which minimizes restrictions for those with 93% rated masks. The guidance should provide more limited access to those with 49% rated CATE masks. They should prohibit access to those with 20% rated CATE masks as they now do for people with no masks.

Since CATE masks are reusable the cost per wearing is low. The fastest and best way to implement this program is not through government purchases but just through guidance and stipulations regarding mask use. The funding can be part of the general support programs already available in most countries.

The private sector has the capability to quickly ramp up production. This can be done cost effectively even though the market will surge and then shrink in 2022. The key is use of materials and resources already supplied in other markets. So this becomes just one more application for a product rather than the sole market. Even with billions of people wearing  reusable masks the weight of non wovens being consumed will be tiny compared to diapers, wipes, or other high volume products.

The technology is also highly developed.  93% CATE masks have been used for years for air pollution protection, wildfires, pollen and immune depressed conditions

Millions of Lives at Risk

The death toll in the United States, currently at 244,250, could nearly double by March 1 to 438,971, the Institute for Health Metrics and Evaluation (IMHE) at the University of Washington’s School of Medicine forecasted in its latest projection.

Add Europe, which is in the midst of a second wave of infections, and the rest of the world, and the global death toll could reach a staggering 2.8 million by March 1, the IMHE projected.

“When you see that Europe is already up to 4,000-plus deaths a day, and it just keeps growing. We’re on a similar trajectory,” Dr. Christopher Murray, a professor of health metrics sciences at the University of Washington and director of the IHME, told NBC News. “We’re just about four weeks behind."

More than a half million lives could be lost to COVID-19 by 28 February 2021 in the USA, suggests a modeling study published in Nature Medicine. The paper also estimates that universal mask use could prevent the worst effects of epidemic resurgences in many states and could save nearly 130,000 of those half million lives.

The first major impact of vaccines will be in the second quarter 2020. So by July 1, 2021 twenty percent of the world could be vaccinated.  This could reach 50% by the end of 2021.  By that point in time the U.S. deaths could reach 800,000 or more. World death tolls could reach 5 million people.

Billions of Masks Needed to Achieve Herd Immunity

CATE is an acronym for Comfortable, Attractive, Tight Fitting, Efficient. These masks have been available for many years to combat air pollution, wildfires and pollen. they are the ideal selection for the general public in the fight against COVID.  Here are the numbers.

In a room where people are social distancing at six feet and MERV 8 filters are used in an HVAC system with three air changes per hour unmasked individuals will be generating a cloud of virus particles similar to perfume or cigarette smoke. If masks are worn by transmitters as well as recipients, the net protection is a combination of the performance of both masks.

The net effectiveness is a function of the potential capability of the mask minus failure to achieve a tight fit and periods where the mask is discarded due to discomfort or social drivers. When all is considered the CATE mask combination is 93% effective compared to only 49% for the cloth mask.

Mask type: CATE masks are generally reusable and have various features to make them  attractive, tight fitting and comfortable as well as efficient. Surgical masks are efficient but not tight fitting. N95 masks  can be fitted for a tight seal but when worn by general public they are often not used properly.  Cloth masks can excel in comfort and attractiveness but are loose fitting and inefficient.

Direct Leakage: This is the amount of air which is exhaled around the mask directly.

Re-entrainment: Droplets initially captured on masks evaporate and split causing virus to escape.

Penetration: This relates to the efficiency of the filter media.

Use Discount: Masks should be worn as appropriate. Cloth and CAT masks are more comfortable than the others and are more likely to be used in borderline situations.

Recipient Load: This is the virus escaping the transmitter mask.

In Leakage: This is the amount inhaled around the mask seals.

There is no question that tight fitting efficient masks are the most effective weapon against COVID. These masks prevented any  U.S. medical staff fighting Ebola to become infected. The COVID incidence among medical personnel in high COVID environments is very low. In cases where these personnel had no choice but loose fitting surgical masks the infection rate was high. If a comfortable, attractive version is available to the general public the battle can be easily won.

A combination of masks and vaccinations can create herd immunity quickly. It will be a combination of CATE, surgical and medium efficiency cloth masks. It will not include inefficient cloth masks.

Because CATE masks are tight flitting, efficient, comfortable and attractive they will be 93% effective where utilized. It was determined that only 1 mask would be needed per quarter due to reusability.  This will be the most cost effective option. 

The surgical masks have high filtration efficiency but lots of leakage. The assumption is that the usage will be just one per day or 90 per quarter. To meet the needs of the world on July 1 2021 with 20% of the 6 billion active people vaccinated there would be a demand for 378 billion masks per quarter. This reduces to just under 38 billion by July of 2022. Since meltblowns are typically used in surgical masks and there is a big investment and delay in building new melt blown lines it is very unlikely that the suppliers would or could gear up for a market which will peak in the next year and then shrink substantially.

The cloth masks range in efficiency. In the example below we have selected relatively efficient designs. Many would have a 90% inefficiency rating. We have selected reusable masks in the $15-30 price range.  Even with a 51% inefficiency rating it would not be possible to achieve herd immunity with only 20% of the people vaccinated. You would need to mask 102% of the active population.

Herd immunity could be achieved by July 2022 if 10% of the active people are wearing cloth masks and 65% are protected through vaccinations. However of the 5% who are not vaccinated, probably half are in fear of side effects. These people will be ones who will want CATE masks rather than cloth masks because of the higher protection.

Because of the huge immediate needs quick herd immunity will only take place with some mix of CATE, Surgical, and Cloth masks. But it is achievable. The Biden Administration is considering a mask mandate. Many countries already have them. The problem is that without specifying effectiveness some people are wearing masks which provide almost no protection.

One way to achieve herd immunity would be to specify CATE masks for those who are at most risk and allow surgical and cloth masks for others. However, for those masks with lower effectiveness some specification must be set. It should be some combination of maximum  penetration plus leakage. Europe has some community mask specifications set around 80% efficient media. However without fit being included the specifications are inadequate.

The requirements can be based on expected load factors. CATE masks could be required in subways and theaters. Lower efficiency levels could be allowed for walking suburban streets or in grocery stores which have HEPA filtration and laminar air flow at checkout counters. This means that people may carry several masks and use the one appropriate for the setting.

The requirements can be synchronized with the production capabilities of suppliers. If the guidelines are set appropriately, we could have herd immunity in six months and save many hundreds of thousands of lives.

Electrospun Nanofibers Available for CATE Masks

Fernando Gomollón-Bel, a freelance writer based in Cambridge, England interviewed some nanofiber producers for an article in Chemical and Engineering News. Excerpts are show below. Subsequent articles provide more information on the companies interviewed based on McIlvaine research. The Alerts have many articles on a number of producers but some of the producers quoted in this article have not been previously analyzed

“Electrospinning is like making spaghetti but using electricity to help us pull,” says Yi Cui, a professor of materials science at Stanford University and cofounder of 4C Air, a start-up that manufactures air filtration systems based on nanomaterials. The technology is not new. Electrospinning was discovered in the 1930s, and “it has been used to make nanofibers for decades,” Cui says. But the pandemic has created a new market.

4C Air was originally formed to develop a material to tackle air pollution. “Fine particles are extremely dangerous, even more than officially recognized,” says Steven Chu, a cofounder of the firm and a Nobel laureate in physics. Chu and Cui say the firm’s nanomaterials filter these fine particles exceptionally well. And since the aerosol droplets that disperse the novel coronavirus are similar in size, they saw a new opportunity.

Maryland-based DiPole Materials also specializes in making custom nanofibers. When the pandemic struck the US, the firm redesigned most of its processes. “We soon started working hand in hand with people that needed our help,” DiPole CEO Ken Malone says. “Had it not been for COVID, we probably wouldn’t be in the filter business.”

Nanofibers make good filters mostly because of two factors: mechanical and electrostatic interactions with aerosol particles. Richard L. Corsi, an expert in indoor air quality at Portland State University, compares mechanical filtration to spaceships flying chaotically through a forest.

“It is like those epic battles in Star Wars,” he says. “If there are many trees along the way, the ships are more likely to crash.” And if the trees are disorganized and entangled with branches, they are harder to dodge.

For this reason, nonwoven fabrics—such as those obtained by electrospinning—are more efficient at intercepting small particles. On top of that, nanofibers have higher adsorption surface areas, giving them a greater ability to capture droplets and particles.

The electrostatic charge imparted by electrospinning also plays a role in how nanofibers filter aerosols. “These interactions give the extra boost to remove additional particles,” Corsi says.

Traditional N95 masks also rely partly on electrostatics. They are made with dielectric microfibers that maintain a surface charge for long periods of time, and aerosol droplets stick to them like pieces of paper to a balloon. But Cui argues that this effect is more pronounced with electrospun nanofibers.

“When you go to small particles and small fibers, the [electrostatic] effect begins to play an increasingly important role,” he says. Cui points to independent testing that shows that the firm’s products effectively filter the most penetrating aerosol particles. 4C Air says all its nanofiber masks have been tested by the US National Institute for Occupational Safety and Health and received the N95 certification—meaning they filter at least 95% of airborne particles.

Nanofibers also make masks more comfortable. “They allow more air to pass with the same filtration efficiency,” says Scott R. Gaboury, chief operating officer of DiPole. The main reason for this is physics—specifically, the resistance that the air meets when flowing through the mask, commonly known as pressure drop.

Usually, the higher the filtration efficiency, the higher the pressure drop, which makes the most secure masks, such as N95s, less breathable. However, pressure drop is inversely proportional to the surface area of filter fibers, which is a plus for nanofibers. “We have measured many brands, and usually the pressure drop is over 100 pascals,” Cui says. 4C Air’s masks reduce that resistance by up to 60%. “The breathability is just incredible,” he says.

The Spanish start-up Bioinicia, which also makes masks using electrospinning, has similar claims on its website. Apart from enhanced breathability, its nanofibers dissipate humidity and heat better than traditional fabrics, the firm says. Water droplets created by condensation can dissipate the static charges on the nanofibers and make them less effective filters. Long-lasting charge makes for long-lasting masks, Cui says. “For regular use, you can probably wear our masks for two weeks without losing any efficiency,” he says.

Beyond masks, the electrospinning firms are developing other types of protective equipment. 4C Air’s original business is making window screens to filter fine particles, including pollen and pollution.

DiPole Materials is creating a variety of custom-made products for local groups and businesses. Rather than masks, the firm manufactures pieces of fabric that snap into 3-D printed plastic mask frames or can be inserted into cloth masks. It’s working with the University of Maryland Medical Center to develop a specialty mask designed by doctors. And it recently signed an agreement with the US Army to create new nanofiber composites for air filtration.

So far, these companies operate on a small scale, particularly DiPole, which has limited production capacity and has fabricated enough material for only around half a million masks. “Technically, scaling up electrospinning is not difficult, but we prefer to focus on creating specialty products and synthesizing unique nanofibers on demand,” Gaboury says. Although big multibillion-dollar companies have knocked on DiPole’s door, the firm kept filter supply local, he says.

4C Air runs a pilot line in the US and two production lines in China. “We can afford a small production of 2 million masks per month,” Cui says. Bioinicia said in July that it hoped to be making 11 million masks per week by now and expanding beyond Europe. The firm didn’t respond to interview requests.

Big mask makers like 3M have not embraced electrospinning; their established techniques are well entrenched and investing in new technologies is risky. In terms of air filtration, it’s safe to stick to proven technologies, Corsi points out. “It is amazing how even very simple masks can help us prevent the spread of the virus.”

Executives at electrospun-fiber firms are aware that masks based on their materials will remain niche items during the COVID-19 pandemic. But they are watching a longer time horizon. “This is unlikely to be the last pandemic,” Chu says, and nanofibers could bring masks with “much better protection and much more comfort.”

4C Air Supplies Nanofiber Based Masks for $3 Each

Air 4C Air has collaborated with AireTech Clean Technology to produce the Nano-Media KN95 Particulate Mask with 4C Air's BreSafe nanofiber filtration media and filtration technology: a nanofiber-based particulate mask that can filter out 95% of dangerous particles, including fine particulate matter from wildfires and harmful germs. It is designed for ergonomic comfort while meeting the high-quality needs of everyday personal protection.

  Effective against harmful smog from fires and pollution, unlike cloth and medical masks

  Five-layered mask for multiple particle blocking sizes and comfort

  High filtration efficiency (>95%) for 0.3 microns particles

  Low breathing resistance compared to competitors

  Certified KN95 (GB2626-2006, equivalent to NIOSH N95)

Masks are sold on the 4C Air website at $3 per mask in boxes of 25.

Dipole Providing Nanofiber Media for Military Protection

DiPole Materials, an electrospinning company that specializes in custom nanofiber manufacturing, has entered into a Cooperative Research and Development Agreement (CRADA) with the US Army Combat Capabilities Development Command Chemical Biological Center (CCDC Chemical Biological Center).

“The CCDC Chemical Biological Center technology developments are very impressive, and we are excited to collaborate with them to utilize Dipole Materials’ capabilities in nanocomposites fabrication for enhanced protection systems to be used by US military personnel,” said Scott Gaboury, CSO with DiPole Materials.

Under the terms of the CRADA, DiPole Materials will utilize its expertise in nanofiber design and manufacturing to develop composite fibers from blends of polymers and inorganic materials capable of abating various toxic chemicals. These DiPole-manufactured composite fibers will have the potential for use in a range of textile materials that can provide enhanced chemical and biological warfare protection for US Army soldiers.

“Last year, when we partnered with the Maryland Department of Commerce to form the Maryland Defense Technology Commercialization Center (DefTech), we wanted to help unlock the economic value of the brilliant work going on in our state’s military research facilities,” said Ken Malone, CEO with DiPole Materials. “This CRADA is another step in that direction and couldn’t have happened without the help of DefTech.”

The CCDC Chemical Biological Center is the nation’s principal R&D resource for chemical and biological protection to US soldiers. The CCDC Chemical Biological Center’s activities span the life cycle of chemical and biological defense research and product development.

Dipole Teaming with Gemstone Bio on Nanofiber Media for Masks

DiPole Materials, an electrospinning company that specializes in custom nanofiber manufacturing, is teaming up with Gemstone Biotherapeutics, a biotech company developing novel, bioengineered products for scar-free skin regeneration, to rapidly accelerate production of filters to meet emergency demand for medical masks.

 DiPole Materials’ and Gemstone Bio’s teams are collaborating to manufacture cuts of continuous roll-to-roll production of nanofiber filters. This material then gets cut into small, mouth-sized squares which are then mounted into medical masks. Gemstone Bio’s expert team brings its practical knowledge of Good Manufacturing Practices and wet lab skills to help ensure and maintain manufacturing quality controls.

“Our team is eager to contribute to the production of materials needed now for rapidly scaled medical mask manufacturing,” said Emily English, PhD, CEO of Gemstone Bio. “Partnering with DiPole Materials is seamless and demonstrates the depth of Baltimore’s biotech and advanced materials’ prowess. As a team, we embraced the opportunity to help our region and the nation during the crisis.”

DiPole Materials’ nanofiber filters are the type used in N95 respirators, which provide high end protection for critical medical needs. The combined teams are working with cut and sew shops, makers spaces and engineering companies in Maryland to integrate newly produced filters into their masks to increase the protection provided to healthcare workers and first responders.

“We couldn’t ask for better partners with Emily and the Gemstone Bio team,” said Ken Malone, Chairman of DiPole Materials. “Time is of the essence in this crisis. With Gemstone Bio and our other Baltimore partners, we’re able to ramp up mask filter production and speed manufacturing to get masks in the hands of medical personnel.

“We’re seeing tremendous partnering among manufacturers and maker communities in our region to address the COVID-19 epidemic,” said Ken Malone, Chairman of DiPole Materials. “We’re eager to deploy our electrospinning manufacturing capabilities to join in accelerating production of critically needed medical masks.”

Bionicia Supplies Electrospinning Equipment and Does Contract Manufacturing

The company supplies electrospinning equipment for a range of industries. This raises the question whether some of the users could temporarily switch to making mask materials.

The Fluidnatek LE-500 is an electrospinning machine conceived to be a pilot-line production tool that provides all of the capability needed to develop a product from initial concept to pilot-scale manufacture. With roll-to-roll collection, large-volume solution reservoirs, and high-throughput multi-emitter spinning heads, the LE-500 is the ideal electrospinning equipment for fabrication of pre-production volumes of production-quality materials. However, the LE-500 can be run either in R&D mode or in manufacturing mode, that way being a flexible electrospinning device as well.