Coronavirus Technology Solutions
April 22, 2021

Value of Mask Fitters is Now Being Understood by CDC

Nanofiber Media Segmented into 300 nm with Wide Distribution Versus <100 nm with Narrow Distribution

Research Consortium has a Counterfeit Mask Alert Guide

Facemask Market and Technologies Webinar on Tuesday

McIlvaine Face Mask Market Presentation

India is in a Crisis and Needs Tight Fitting Efficient Masks

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Value of Mask Fitters is Now Being Understood by CDC

When Dr. Anthony Fauci heads to work at the White House or the National Institutes of Health, the nation's top infectious-disease expert is often sporting not one but two face masks.

He's said this double-masking strategy helps his masks fit more snugly and comfortably. But double masking hasn't been backed up by any studies or scientific recommendations.

Scientists at the Centers for Disease Control and Prevention are testing whether two masks are better than one, but they don't have enough evidence to recommend it.

In the meantime, there's one lab-tested solution that can make almost any mask more effective: the mask brace.

Also called a mask fitter, the brace goes on over a single face mask to ensure a snug, secure fit and to close any gaps where contaminated air could rush in or escape. In scientific studies from research universities around the US, it's performed nearly as well as N95s, considered gold-standard medical face masks.

Mask fitters are designed to help the mask hug the contours of your face.

"These reusable devices help improve the fit of a cloth or a medical mask by creating a tight fit," Dr. John Brooks, the chief medical officer for the CDC's COVID-19 response, recently told reporters during a virtual briefing from the Infectious Diseases Society of America.

The mask brace fits over a surgical mask, over the nose and cheeks. 

Unlike double masking, he said, "fitters have been scientifically demonstrated to improve filtration performance by as much as 90% or more, which, again, is getting into that range of filtration efficiency afforded by N95 respirators."

Fitters have been tested by independent scientists at the University of Wisconsin, the University of North Carolina, and the University of Iowa. Each institution found that they improved how well masks worked to keep your germs away from other people and to keep other people's germs away from you.

"Most masks, like surgical-style masks or just a simple knit cloth mask, they're leaking," David Rothamer, a mechanical engineer who coauthored the University of Wisconsin's recent study on mask fitters, told Insider. "Like 70% or 80% of the air is bypassing the mask."

Rothamer also said that double masking could, in some cases, do more harm than good.

"It's not as simple as a 'two is better than one' equation," he said. By creating more pressure between a person's face and their mask, double masking could increase leaks out of the sides and the top of the masks.

But it's hard to know whether that's the case, because there haven't been good, clear protocols established to help you know whether your mask is working well.

"I wish the government would have kind of stepped in and, at least from the mask side, given better guidance," Rothamer said. "The somewhat frustrating thing is I think there was an opportunity to say, 'OK, we can use scientists to design this, use experts, design something that's cheap to produce, do it at high quantities, and get these things out there.'"

That didn't happen. Sabrina Paseman, a former Apple engineer, created a crowdfunding campaign last spring to get the job done. Her brace is what researchers including Rothamer have used in their studies. It has also been unofficially endorsed by many leading coronavirus scientists, including Don Milton, a virus expert from the University of Maryland, and Linsey Marr, an air-quality pro from Virginia Tech.

Katherine and Sabrina Paseman, sisters and cofounders of Fix the Mask.

Paseman's company, Fix the Mask, has estimated that 30,000 of its mask fitters are in use on faces around the world. (Some of those are DIY versions from a rubber template the company shares on its website.)

"There are three things that matter with your mask: how well it filters, how breathable it is, and how well it fits," Katherine Paseman, the chief operating officer of Fix the Mask, told Insider.

To make sure your mask is breathable, put the mask on with a fitter or with your hands cupped around your nose and mouth to seal it, and ensure that you can still breathe comfortably. It may inflate a little as you're doing this test, but it should feel like air is being filtered through the mask, not escaping out the sides or the top.

Then ensure that it fits snugly and that there aren't large gaps above the mask on your cheeks or on the sides.

One way to secure the fit is to tighten the ends of your ear loops using rubber bands or rubber fasteners. But research has found that mask fitters can make your mask even more effective — closer to the effectiveness of an N95 mask.

"It's one compression-molded piece made out of silicone," Paseman said, adding that this avoids leakage so that "I know I'm actually getting the real filtration performance out of the mask."

Fix the Mask is hoping to receive certification from the National Institute for Occupational Safety and Health for its product in the coming months. That could mean it's recommended for use — along with compatible, approved masks — for millions of workers in high-risk environments across the country.

Whether you're double masking, using a mask brace, or doing neither, it's important to know that most masks on the market aren't rated to any uniform medical-grade standard.

"You have basically an unregulated bunch of products," Rothamer said. "Nobody really knows how they perform, unless you're someone like me who has a couple hundred thousand dollars' worth of equipment to test it."

If you want to ensure that you're wearing a mask of good filtration quality, try to find one that's ASTM-certified level one, two, or three: Level one is good enough for general use in everyday clinical settings, while level three is for filtering heavy levels of aerosols.

Whichever mask you choose, and whether you decide to double mask or not, pick a solution that you'll actually wear and feel comfortable in — one that keeps both your nose and your mouth inside.

"If we could just get people to wear masks properly, that would be a huge first step," Rothamer said. "You've got to wear the mask, and it has to fit well."

All the experts can agree on that.

"Any mask is better than no mask," Brooks said. "Regardless of what we use, it's critical that as many of us as possible mask up."

Nanofiber Media Segmented into 300 nm with Wide Distribution Versus <100 nm with Narrow Distribution

McIlvaine published a summary of  the new nanofiber production method by KAIST and then asked some the experts such as Kari Luukkonen of Fibertex as to how this development should be viewed. The result was the view that there are two products. 

·         300 nm fiber diameter average with wide distribution

·         100 nm fiber diameter with a narrow distribution

In the article we wrote “ KAIST researchers have developed a novel nanofiber production technique called 'centrifugal multispinning' that will open the door for the safe and cost-effective mass production of high-performance polymer nanofibers. This new technique, which has shown up to a 300 times higher nanofiber production rate per hour than that of the conventional electrospinning method, has many potential applications including the development of face mask filters for coronavirus protection”

It was suggested that  this technology is similar to others e.g. DuPont hybrid technology and similar Cummins technology.

FiberRio force spinning (Parker) makes similar products. The nanofiber created have quite wide fiber diameter distribution from 100 nm to 700 nm, average being typically around 300-400 nm. The upside with this technology is the large output. Products coming from this fiber diameter range are most suited for applications where some depth and strength (=enough weight) from the fine fiber layer is required.

The largest application is diesel fuel filtration and oil filtration.  This product is being used in  mask materials. Suppliers are Cummins, DuPont and Parker. Pardam in Czech Republic  has one machine based on FiberRio technology.

For the higher end surface and depth air filtration the 100 nm and below nanofiber with very precise fiber distribution (plus minus 20 nm) gives the best efficiency / pressure drop ratio. These are done with solvent electrospinning either by wire or nozzle type of machines.

Also for the textile membranes and other membranes for venting and liquid filtration solvent electrospun  (wire or nozzle) gives most uniform pore size. The more narrow the fiber size distribution the more precise is the pore size and elimination of pin holes in the product. By measuring bubble point this can be observed easily.

Research Consortium has a Counterfeit Mask Alert Guide

The Research Consortium announced the availability of a guide to alert consumers to the emergence of substandard and counterfeit reusable face coverings and equip them to identify and avoid them.

Concerned that face coverings vary greatly in their effectiveness at source control and wearer protection, under the oversight of the CDC’s National Institute for Occupational Safety and Health, the ASTM International standards organization created a new international standard for manufacturers and consumers alike.

The new Standard Specification for Barrier Face Coverings (ASTM F3502) establishes baseline design, fit and performance criteria for manufacturers and an easy, uniform method for consumers to evaluate them. Essentially creating the “barrier face covering” product class, it also gave rise to some unintended consequences: substandard and counterfeit face coverings and companies willing to make them. Consumers (individual, government and corporate) need to be aware of, concerned with, and equipped to identify and avoid these products, ergo the guide.

Written by Richard Nicholas, a forty-year veteran of the healthcare industry, and a member of the ASTM committee that developed the standard, it details how consumers can identify substandard and counterfeit products: the distinction being that substandard products simply fail to meet the standard’s requirements, while counterfeits are ones that are falsely claimed to comply with it.

Intended for individuals, employers and professional advisors (e.g., purchasing, HR, workplace safety, loss control, risk management) — as well as medical directors and health system administrators —

How to Avoid Buying Your Family and Employees Counterfeit and Substandard Reusable Face Coverings addresses everything from the standard’s requirements; to interpreting mask classification labels; to consumer warnings about those aspects of face masks that pose potential health, safety and environmental risks (a topic that has not been fully developed in this first version of the standard).

Nicholas surveyed manufacturers, distributors and retailers that falsely represented their face coverings as being “ASTM F3502-compliant” or “certified” and found that noncompliance was both accidental and deliberate. Most were unaware of the standard’s requirements; many mistakenly believed that their “outmoded” past performance tests are sufficient to satisfy the standard; some expressed little concern for putting the public at risk.

Not surprisingly, Nicholas found manufacturers that are knowingly making false claims about their products’ being compliant or “certified” solely to gain market advantage.  Some haven’t even gotten their masks fully tested to the standard’s specifications.  In part, this is because the laboratories (e.g. Intertek, SGS, Eurofins, ICS, Nelson) have only recently become prepared and accredited to perform ASTM F3502’s unique tests and assessments, and some still remain confused as to its requirements.

According to Nicholas: “Substandard and counterfeit face masks are dangerous because they foster a false sense of security…for wearers and those around them.  Consumers must be certain that the products they buy are compliant with the new standard as their well-being, and that of their family and employees, is at stake.”

Among national standards, ours is unique in its use of the rigorous NIOSH-based particle filtration efficiency test which yields much lower results (< 60% vs. > 95%) than the traditional tests familiar to consumers.  It requires design, leakage, fit and biocompatibility assessments and retesting after the claimed maximum number of washings to evaluate performance and fit with prolonged use.  Manufacturers must evidence meeting ALL the standard’s requirements in a Conformity Assessment Report to be compliant.

ASTM F3502 has been adopted by the FDA.  Other agencies (e.g., OSHA) with enforcement capability will soon follow; the FTC, DOJ and some state AGs have already begun counterfeit and fair-trade investigations.  A new World Bank sponsored global campaign is underway to raise awareness of community mask standards as well an initiative to establish an online voluntary “registry” for products claiming compliance to evidence such.

Deception isn’t limited to consumers. Yahoo! featured articles having a manufacturer’s claim that its face masks “…got an ASTM certification”.  TODAY and NBC News published articles with a false manufacturer claim that its products were among the first to get “certified” and “proven to meet” the new standard.  To their credit, upon learning from Nicholas that ASTM doesn’t “certify” face coverings, Yahoo! promptly deleted its articles and NBC News issued this correction: “After consulting lab reports and experts, NBC News confirmed that the masks did not meet a new standard for reusable masks” and removed the product from its best face mask listing.

How to Avoid Buying Your Family and Employees Counterfeit and Substandard Reusable Face Coverings is available  at www.researchconsortium.org   

Facemask Market and Technologies Webinar on Tuesday

WFI is conducting a course next week on face masks.  Bob McIlvaine will provide a brief overview of the market. His slide presentation is included below.

April 27th, 2020, Tuesday

8:00am-10:00am,  ET Canada & US

$USD 350

$USD 175 (Member Only )

Register Course Online

Course Objectives:

The objective of this course is to provide you the latest update on facemask market analysis and the technologies used to make facemasks, especially meltblown and electrostatic charging technologies, as a primary method used for making core facemask filtration layers. We will also discuss the latest developments on test methods and certification standards for the facemasks, as well as the trends for future growth.

Course Outline:

1. Instruction (Christine Sun, 10 min)

2. Updated Market Analysis (Bob McIlvaine, 20 min)

a. Risk Reduction Assessment

b. Near-term and Long-term Market Strategy

3. Meltblown Processes and Electrostatic Charging Technologies (Peter Tsai, 50 min)

a. Review of meltblown technologies

b. Fundamentals in meltblowing process design

c. Process parameters and web properties

d. Meltblown advantages for filters and facemasks

i. Unique meltblown characteristics in filtration

ii. Meltblown polypropylene electret

e. Electrostatic charging techniques

f. Charge decay and durability

g. Recent developments

4. An outline of current medical face mask performance requirements and testing (Janelle R. Bentz, 25 min)

a. Medical Mask Test Method Standards

b. NOISH Test methods

c. Barrier Face Coverings

5. Trends for further growth (All speakers, 15 min)

a. Panel Discussion

b. Q&A

Instructor Biography

Dr. Peter Tsai

President @ Waterloo Filtration Institute

Dr. Tsai has over 40 years of expertise in development of meltblowing (MB) system and the electrostatic charging (EC) of materials for making air filter electrets. The MB and the EC technologies developed Dr. Tsai have been used in the industries worldwide making billion pieces of N95 of face masks, and many other applications in air filtration. He receives three most prestigious awards from the University of Tennessee (UT) in recognition of his contribution in technology innovation and transfer. Dr. Tsai is entitled by AFS as a Fellow Member, famous for his invention of electret meltblown technologies for N95 facemask and air filtration applications.

Janelle R. Bentz, MS, Nelson Laboratories

Janelle has been employed at Nelson Laboratories for nearly 6 years and is the department scientist in the Protective Barriers department of the company. As an expert in many of the surgical gown and drape and medical face mask and respirator standards, she helps oversee the testing in this section. As convener of ISO TC94/SC13/WG6, she helps lead standard development for testing medical protective clothing. She is currently pursuing an MBA at Brigham Young University in addition to responsibilities at Nelson Laboratories.

McIlvaine Face Mask Market Presentation

Bob McIlvaine will discuss  the face mask market and these broad conclusions.

India is in a Crisis and Needs Tight Fitting Efficient Masks

India has not accurately reported COVID cases. Experts believe that 400 million people have been infected and that a billion people are at high risk.

Even though India is a major vaccine producer there is an inadequate vaccine supply. Due to refrigeration requirements rural use will be problematic. The one reliable option would be tight fitting and efficient masks

In just two weeks, India’s second wave of Covid-19 has become disastrous.

The country, which was reporting less than 15,000 cases a day just last month, has been seeing over 200,000 Covid-19 infections a day since April 15. On April 19, India reported 273,810 new Covid-19 infections and 1,619 deaths—both highest single-day spikes. That takes the active Covid-19 caseload tally up to nearly 2 million.

The current wave started in the western states of Maharashtra and Gujarat and has now engulfed almost the entire country.

Delhi, for instance, had only around 2,800 new infections on April 1, and active infections stood at 10,498. Yesterday, it recorded 25,462 infections and an active caseload of 74,941. That amounts to a 900% increase in new infections and a 700% increase in active cases in just 18 days.