McIlvaine Coronavirus Market Ale

Mask Webinar Contained Lots of Discussion but not Much Disagreement

A Few Large Suppliers Can Stop COVID Quickly

Air Monitoring, Mask Quality Control, and Air Filtration are the Major “Pull” Tools

Experts Tell CNN that Four Weeks With Everyone in N95 Masks Would End the Pandemic

Some European and Asian countries are now requiring the wearing of high efficiency masks in public. The ASTM is about to release a labeling program to allow mask purchasers to distinguish between two efficiency levels. Many experts are now advising that the big difference in protection makes it essential that people wear highly efficient masks.

An $80 billion dollar market now exists for masks which will not be able to meet the efficiency requirements of the near future. This is an average of $10 per year for each citizen of the world. With the requirement for more efficient masks and 100% use the market could exceed $240 billion or $30 per year per person over the next twelve months.

Mask Market Potential for Next 12 months
Product or Service	$ billion	Details
Media	18	Meltblowns, spun bond, wovens, membranes, nanofibers, cloth and various laminates
Components	12	Structural components, ear loops, seals, braces, coatings
Mask Manufacture	110	Mask manufacture and assembly
Service and Consulting	45	Variety not the least of which is quality control and testing
Distribution and Fit	55	Distributor mark ups plus fit testing and mask selection support
Total	240

Mask Webinar Contained Lots of Discussion but not Much Disagreement

The mask webinar last week was more popular than we anticipated and a number of people who tried to participate could not. However, the webinar was recorded and is posted on YouTube. In case you wanted to ask questions or debate issues, you can do so through input in the Alert.

Dave Rousse of INDA explained how the non wovens association group had understood as early as March that some standard would be advisable for public masks. INDA started working with ASTM. The result is a standard soon to be released which sets two efficiency levels. One is 20% or higher. The other is 50% and higher. When you consider that the virus is generally in larger particles or drops than used for the efficiency rating and that the effectiveness is the combined efficiency of masks on emitters and recipients these standards will greatly reduce COVID spread.

Eric Couch, consultant, believes the new administration can be persuaded to champion the new ASTM standards. His concept is to keep it simple and to first persuade a small group of experts with influence who would then persuade the decision makers.

It would be interesting to hear from Dave and Erick as to whether the new N95 mask requirements in Austria and possibly Germany will impact U.S. standards. They should give the Biden Administration ammunition to hold out for some mask efficiency program.

Eric recommends the use of multiple mask designs including one with flat filters and external braces. This design lends itself to quick scale up. Sabrina and Katherine Paseman of Fix the Mask, have designed an external brace which is comfortable and tight fitting. It gives surgical masks the tight fit and efficiency of N95 masks. During their presentation they pointed out the wide availability of surgical masks. With the Essential brace these masks would make most people safe.

The brace would also make more media available for filtration. This is important as Dave Rousse pointed out the 5 mm H2O maximum resistance for the 50-100% mask was a stumbling block and may result in lower efficiency masks. Since pressure drop increases as the square of velocity it will not take much additional filter media area to reduce resistance.

Keith Dellagrotta and Jesse Chang of M^3D.ai have a program where a mask purchaser can use his mobile phone and select a mask which will provide a good fit. They are collaborating with Vogmask who has five different mask sizes. Based on the phone image the right size mask can be chosen. Jesse points out that most masks are designed for average sized Caucasian males. The face size and shape differs greatly among the general population.

Jesse was asked about use of the phone app as a check on entrants to safe bubbles. He acknowledged that it would be good for that purpose but is worried that it might be an infringement of citizen rights. However, if it is going to be required to wear a mask it makes sense that requiring the wearing of efficient masks is no more of an infringement than the general mask mandate.

Bob McIlvaine introduced a five step program starting with mask manufacturing quality control, distribution quality control, an ASTM or governmental minimum, a tested quality seal, and fit check. This has been also covered in the recent Alerts. The concept is that a mask purchaser would have two guides. The basic minimum guide would be an ASTM or community standard (Europe). In addition masks could also have a seal attesting to a higher level of performance than in the basic guide. The seal attests to specific filter testing as well as to quality control throughout manufacture and distribution.

We have identified SGS, Eurofins, MPR, Mann-Hummel, Daikin, Johnson Controls, Ahlstrom, Camfil, 3M, Honeywell, Cummins, Lydall, Berry, and dozens of other companies who are capable of quickly implementing the Pull portion of the Push-Pull system.

ASTM labels and European Community mask initiatives along with local and country regulations provide the “push”. Part of the push program is to limit occupancy of buildings. If you limit occupancy to 25% whereas average occupancy is 50% you have reduced the COVID risk by half. The “pull” part of the program is to offer validation for the actual risk and alternative methods to reduce the risk to much lower percentages.

In earlier Alerts we pointed out that most facilities have many reasons to make visitors or employees feel as safe as possible . If the risk is reduced to the equivalent of 10% occupancy It is five times lower than required.

The products and services are available to implement the “pull” initiative immediately. The challenge will be to create a rating system to reflect the increased safety.

Eurofins has already done this for community masks. We discussed their initiative on January 20. Here is their tested quality seal. Note that by validating fit and comfort they are making qualitative judgements. A validation of risk reduction compared to 25% occupancy involves a lesser qualitative component than one on comfort.

One company with a number of applicable products and services is SGS. One is a mobile monitoring laboratory

“SGS is adding to our comprehensive COVID-19 Recovery Assistance Services by coming directly to your location with our team, analytical expertise and rental offerings. Our mobile laboratory and field-deployable testing and analytical equipment are now available for SARS-CoV-2 detection in air and on surfaces.

SGS now offers near real-time Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) data in air and on surface swab sampling with our new mobile laboratory or RT-qPCR instrument and analyst options. The ability to provide near-real-time SARS-CoV-2 presence data using gold-standard RT-qPCR, eliminates the 2-3-day turnaround time that was needed to ship samples to the lab and wait for results, a major step in speeding reaction to possible COVID events. The service supports analysis of air monitoring using Teflon air filters and swab testing for cleaning verification.”

LuxuryRes, in collaboration with SGS, has developed and launched a new Hygiene Monitored (HM) program to help hotels address the spread of COVID-19. Here is how the user explains the benefits.

“With a focus on selling, managing, and marketing hotel properties with the use of its own reservation and management technology, LuxuryRes will now be able to provide cleaning audits via both self and remote assessment as a result of the HM program.

Hotels that successfully pass their audits will be able to display the HM Mark, which not only verifies their enhanced hygiene practices, but also makes booking easier for business travelers, as the HM mark enables them to compare the hygiene levels of inspected hotels.

The HM program comes at a time when cleaning and safety standards for travelers have become the most important deciding factor for corporations reviewing their business travel programs in response to COVID-19. Hotels will be able to use the HM program to validate the thoroughness of their cleaning procedures and increase hotel occupancy. The program includes a dedicated addendum covering compliance with WHO guidelines, which will help hotels to demonstrate their commitment to mitigating the spread of the virus.”

Note the claim is to “validate thoroughness of cleaning and increase hotel occupancy” So this is highly qualitative and clearly shows the desire of the user to do something better than the minimum

SGS is very involved with air monitoring including indoor, ambient and stack monitoring, Through its Galson subsidiary it rents particle counters and other equipment

Galson also supplies Smart Sense which monitors volatile organic compounds (VOCs), carbon monoxide, temperature, pressure, humidity and other contaminants. SGS Galson has brought the Internet of Things (IOT) — networking smart devices to enable data collection and exchange– to the industrial hygiene industry with the SmartSense cloud-based monitoring and sampling initiation system. Direct read capabilities include Total Particulate, PID, CO, CO², SO², O³, EtO, CH⁴ and more. Paired with the direct read sensors, active sampling capabilities include silica, VOCs, metals, and more! This is a great tool for collecting exposure data 24/7 for Indoor Air Quality (IAQ), wildfires, perimeter and task monitoring, and other monitoring situations.

The next article explains how all these capabilities can be used in the Pull initiative.

Air Monitoring, Mask Quality Control, and Air Filtration are the Major “Pull” Tools

Masks are the most important tool. If everyone entering a “safe bubble wears a tight fitting efficient mask the virus risk is reduced to the equivalent of 1% occupancy. However, in lunch areas, bathrooms, and in private offices or other low traffic areas where it will be desirable to remove the masks it will be necessary to filter the air.

Elevators and other spaces where there is higher than typical risk should also be supplied with HEPA filtered air. Restaurants can employ Fan Filter Units in the ceilings. Partitions are a poor substitute.

In order to provide rating such as “equivalent to 1% occupancy” an air monitoring and control system is required.

McIlvaine has written extensively about these systems in Coronavirus Technology Solutions and also recorded interviews such as

By integrating HVAC, lighting and security systems into a single digital platform like Johnson Controls Metasys® building automation system, building owners and operators can easily troubleshoot issues and implement system changes.

Tyler pointed out that the system can provide the right balance between energy consumption and safety. In areas with higher virus loads more efficient filters can be utilized and the number of air changes can be increased. More outside air can be used to dilute the virus load. But this brings up the subject of the contaminant burden in outside vs indoor air. In polluted areas the particulate load from outside air will be significant.

July 15, 2020 - qlAir interviewed on holistic approach to providing clean air solutions for COVID

Ellie Amirnasr and Marcel Schoch explained how measurement of particles, CO2, humidity and other air constituents can be the basis for providing COVID mitigation solutions which balance effectiveness and cost. The use of the approach in a mall was discussed. The degree of social distancing and the percentage of outside air in a given space can be determined based on CO2 content. An actual case history in a hospital was used as an example. The problem was VOC reduction. But the approach would be the same for COVID minimization.

Tim Werkema and Bret Asper of Cleanrooms International discussed the recent activity in converting hospital rooms to negative pressure isolation units using their fan filter units. The units are supplied with wheels for convenient temporary installation. They can be used without ductwork or with a duct through the wall or a window to the outside. The units have variable speed drives and air flow can be controlled. The company was able to meet the sudden demand by hospitals for thousands of these units. The 2 ft x 4 ft HEPA filter is efficient at removing viruses. The company is equipped to meet the rising demand in meat processing and other industries as well as in healthcare. To view this YouTube recording click here: https://youtu.be/Bm3_Q0a0r2E

Since our earlier webinar with PathO3Gen Solutions there have been many more examples of foot sanitizers reducing pathogens. Hospitals are quantifying the reduction of HAI including coronavirus with sanitizers placed at main entrances and to sensitive areas such as compounding pharmacies. Charlie Rodriguez and Robyn Collins explained why a combination of ozone and UV light makes a foot sanitizer very effective for reducing infections. The sanitizer is finding use in cleanrooms, food manufacturing, restaurants and other facilities. To view this YouTube recording click here: https://youtu.be/2k1_pB21wKw

The monitoring and control program can include the number of people in various locations in the facility, the quality of air in that location and the verification that each person entering the building wears an efficient mask. In areas where fan filter units are used for local air purification the air flow direction should also be monitored.

The software can also qualitatively assess the risk when masks are removed in low traffic areas. The PM levels in the area served by the FFUs can be compared to that elsewhere in the facility.

The program can be initiated either with collaboration or by individual initiatives of the major suppliers. SGS can expand its LuxuryRes program for hotels by adding a Virus risk validation to the one already in place on sanitation.

Mann +Hummel has the air monitoring software, the filters and reusable masks to move forward. Daikin with its HVAC and air filter activities is equally well positioned. It already has a holistic approach as explained by Nathaniel Nance in a McIlvaine interview. To view this YouTube recording click here: https://youtu.be/3nqNhOwBHuQ

The positive receptivity to the approach for hotels was demonstrated by LuxuryRes. Schools, restaurants, churches, theaters, sport stadiums, fitness centers, dental offices, malls and most other facilities which attract the public will have similar incentives.

Devabhaktuni Srikrishna followed up with comments relative to making sure that the most vulnerable are protected quickly. He writes “As Dave Rousse alluded to there may now be enough meltblown capacity for N95 and surgical masks to support certain population segments of end-users beyond healthcare. Currently production capacity is at 275 million masks per month per Dave’s notes in Bob’s January 19 newsletter. Is it feasible (thinkable) to outline a quantitative proposal (options) for the federal government to rapidly get high-filtration masks + fitters out to the most vulnerable population segments such as seniors to flatten the curve? That’s about 50 million in the US.

Germany is a model (below). They are giving “vouchers” to all senior citizens (60+ or 34 million people) to be redeemed for twelve FFP2 masks (N95 equivalent). Vouchers or credits create the demand signal needed to activate the supply and distribution network.

However as we know in the hands of senior citizens these medical masks (N95 or surgical) are unlikely to achieve a good fit defeating the purpose. A mask fitter (e.g. Fixthemask) can help if we implement this type of voucher program or ship them in a kit in the US. A program like this would be in US states that are willing of course maybe as a federal-state matching program. Right now California especially LA is in dire straits with hospitals maxed out. I fear other states may not be that far behind California.

Austria is also giving FFP2 to those over 65 years old. Other EU countries like France and UK are probably not far behind.

Meanwhile, the German government increased its earlier offer of sending millions of vouchers for the FFP2 masks to people believed to be at the highest risk. Officials previously said they would make the vouchers available to 27 million people, but this has been increased to 34.1 million on Monday.

This builds upon the southern state of Bavaria's decision Monday to mandate the wearing of FFP2 masks instead of other mouth and nose coverings for all citizens in shops, on public transport and in other situations.

Those identified as vulnerable - generally people aged 60 and over as well as those with certain chronic illnesses - will now be able to collect 12 FFP2 masks at pharmacies with vouchers to be sent out in the coming days”

The Respo is an aesthetic hard-shell face-mask with a removable pleated N99 filter, a flexible TPE gasket, around-the-head elastic adjustable straps, and a clear PolyCarbonate face-shield. It’s a mask that’s built to be worn for long hours without feeling any discomfort, and that pleated N99 filter does a far better job of trapping microparticles and microorganisms at a given resistance than a flat HEPA filter sheet.

The idea of pleating a filter, however, is very new to consumer face masks, but that’s probably because the category has only exploded over the last six months. While pleating a filter does make it much more effective, it also contributes to a mask’s thickness, but Response Laboratory says it figured out a balance between effective pleating and an overall sleek design. Respo’s filter exceeds the N99 standards, trapping even the finest particulate matter including viruses, allergens, pollen, and bacteria to deliver 99.5% clean air to your nose and mouth. The filter snaps right into the Respo hard-shell mask, which is engineered with a valve-less design for overall safety. The recycled ABS outer shell creates a spacious chamber inside the mask, while the TPE gasket around the rim ensures the utmost comfort for all face-types (even if you have a beard).

The Respo mask comes in a standard variant as well as a full-face variant outfitted with a face-shield module. Designed to cover eyes along with purifying air for nose and mouth, the Full Face Respo mask features a curved PolyCarbonate shield that molds to cover the face by curving around the forehead and temples to create a 180° protective visor.

Whether you opt for the full-face variant or the standard variant, the Respo is entirely modular and can be disassembled to either replace the N99 filter or to sanitize the rest of the components. Each mask ships with 10 replaceable N99 filters, giving over 400 hours of use. The Respo masks come in a range of sizes across a variety of colors and sells for $50 to $70.

Confronting new, more transmissible variants of the coronavirus and a winter spike in infections, a number of European countries are beginning to make medical-grade face masks mandatory in the hope that they can slow the spread of the disease.

The French government has now mandated that citizens wear single-use surgical FFP1 masks, more protective FFP2 filtering facepiece respirators or fabric masks which meet the same "Category 1" specifications -- blocking more than 90% of particles -- in all public places. In layman's terms, homemade masks will no longer cut it.

It follows a decision by the German government on Tuesday requiring all people to wear either FFP1 or FFP2 masks while on public transport, in workplaces and in shops. The move came after the German state of Bavaria introduced an even more stringent measure: Enforcing surgical grade N95 respirators, which filter 95% of air particles, in stores and on public transport.

Austria will introduce its own FFP2 mandate on public transport and in shops from January 25.

German Chancellor Angela Merkel cited the spread of new coronavirus variants, which were first detected in the United Kingdom, South Africa and Brazil, as the reason for stricter requirements. "I urge people to take this seriously. Otherwise it is difficult to prevent a third wave," Merkel told journalists in Berlin on Thursday, adding that a video summit of European Union leaders would be focused squarely on ways to counter the spread of variants on the continent.

During the Thursday summit, EU leaders weighed tougher border restrictions to limit non-essential travel and agreed to a common framework for rapid testing, but mask-wearing was not discussed.

The European Center for Disease Control and Prevention (ECDC) warned Thursday that new variants of the coronavirus could cause more hospitalizations and deaths across Europe, urging countries to start taking extra measures -- from physical distancing, to quarantining and contact tracing -- immediately. The ECDC currently recommends face masks in indoor and outdoor situations when physical distancing cannot be guaranteed but does not specify what type of face covering should be used.

Meanwhile, in Britain, where a highly-contagious coronavirus mutation is driving a deadly third wave of the virus, medical-grade masks have not been mandated in public. Instead, face coverings are required on public transport, in shops and in other indoor settings where social distancing may be difficult.

In the UK government's Covid guidance, scarves and bandanas are considered to be appropriate face coverings, despite evidence they do not effectively block respiratory droplets emitted by the wearer.

Faced with more transmissible variants, some scientists say that the focus should be on limiting the amount of viral aerosol exposure as much as possible -- and recent studies suggest the best way to do that is through medical-grade masks, in addition to other public health measures.

Unlike fabric and surgical masks, which protect other people from larger respiratory droplets emitted when speaking, coughing or sneezing -- in other words, outflowing air -- FFP masks protect the wearer by filtering both the outflow and inflow of air. They can also provide some level of protection against smaller droplets, or aerosols. When fitted correctly, FFP2 masks can filter at least 94% of particles.

Experts Tell CNN that Four Weeks With Everyone in N95 Masks Would End the Pandemic

The message about the potential for more efficient masks is now reaching the public. Here is the analysis by CNN

On Wednesday, after the inauguration, White House press secretary Jen Psaki showed off her bright white N95 mask in the press briefing room. "I wore it out, of course, here today and will continue to do that," Psaki said after removing her medical-grade mask and before turning to questions.

The filter works by trapping neutral particles like bacteria and viruses before they pass through the mask, protecting the wearer and those around them. It's similar to how socks might get stuck to a blanket in the dryer. The N95 mask, which costs roughly $5, also fits securely to the face, eliminating most of the leakage that may occur with a loose-fitting cloth or paper mask.

Studies have shown that masks significantly decrease the chances of transmitting or contracting the coronavirus. But not all masks provide equal protection. Depending on the fabric and number of layers, homemade and simple cloth masks have a range of effectiveness that can be as low as 26%, which leaves the wearer vulnerable.

Some experts like Brigham and Women's Hospital and Harvard Medical School physician Dr. Abraar Karan have been advocating for public use of N95 masks from the start of the pandemic. In an interview with CNN Chief Medical Correspondent Dr. Sanjay Gupta, Karan outlined why N95s are critical at this stage of the pandemic.

If for four weeks the country essentially wore these masks in those risky settings like that indoors, what kind of difference do you think it would make?" Gupta asked.

The quality of protection a face mask can provide is crucial. A respiratory illness like the coronavirus is transmitted through aerosols, tiny particles that waft and hang in the air. Some virus-carrying particles are small enough to travel through or around lower-quality masks, making the wearer vulnerable to inhalation of viral particles.

"We know now that aerosols spread best when there is poor ventilation, crowding and close contact that's prolonged," Karan told Gupta in an interview. "So we were arguing that actually in those settings, cloth masks alone are not going to block aerosols."

Karan is not the only expert who has been vocal in support of better quality masks for the general public. Former US Food and Drug Administration Commissioner Dr. Scott Gottlieb wrote in an op-ed in the Wall Street Journal that "encouraging Americans to wear higher-quality masks is a simple step that might make a difference."

The biggest problem is lack of supply. This week marked a full year of the coronavirus, and the Biden administration has committed to invoking the Defense Production Act more often to boost manufacture of N95 masks and other critical supplies. Experts hope manufacturing will hit a speed to be able to sufficiently supply the population.

"An N95 that's well-fitted clearly is the best that you can do," National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci told CNN Friday. "You could get production of that at a much higher rate now."

Karan believes N95 masks could be an essential asset in reopening the economy as the vaccine rollout remains sluggish and quarantine fatigue soars.

"If we have better personal protection for people, they can more safely go back to work. They can more safely re-engage, especially if testing and tracing is not where we need it to be," Karan said.

"This was going to be one way to get people back in and get the economy back up."

After months of treating coronavirus patients, Karan says it's time to invest in making sure masks people wear are even more effective. "Focus on getting better masks to as many people as possible, focus on the messaging around masks, be consistent with your messaging, make masks part of American culture to stop the epidemic."

(This analysis has good information the South Korean masks but seems to ignore the importance of air leakage.) As Stephen Morse, an epidemiology professor at Columbia University, puts it, a KF94 is essentially the South Korean equivalent of the N95. They're "pretty comparable," he says. For a visual image, you can think of a mask between an N95 and a typical cloth mask. The KF94 comes with side flaps, which mold to the contour of your face, and an adjustable band around the bridge of your nose.

To understand how it works, all you have to do is investigate those mysterious initials.

Sonali Advani, an assistant professor of medicine at Duke University, explains that KF stands for "Korean filter." And 94 refers to its filtration efficiency (basically, just how good the mask is at filtering out particles we don't like), which is 94%. Not surprisingly then, an N95's filtration efficiency is 95%.

But Advani doesn't think the KF94 is a game changer for how we should all approach mask strategy. "While there are minor differences, those differences are rather small in general," Advani says. "It's negligible."

But they are easy to come by. Says Morse: "KF94s seem to be more readily available than the N95, less expensive [generally under $2 each] and easier to use for many people," Morse explains. "KF94 is actually intended for public use. In Korea they are often worn by ordinary citizens to filter out dust or pollution."

"When it comes to use in day-to-day activities, overall surgical masks and three-layered cloth masks perform pretty well," Advani says. As far as protection goes, masks with multiple layers will do you better in staving off potentially infectious particles than thin ones – and studies have shown that three layers is typically the sweet spot.

In other words, she says, there's no need to go out and buy up medical-grade KF94s — especially, she says, since some wearers have said the South Korean mask is less comfortable or harder to breathe out of than the alternatives. (The Adani analysis does not seem to take into account leakage. So her conclusion is not supported by the weight of evidence now being generated about the importance of fit)

The bottom line is this: "It's not always just about filtration efficiency," Advani says. "While these masks [such as the KF94] may be better for use in a hospital [because they're designed for medical settings], in the real world, it may be the case that they are hard to wear through the course of the whole day. And the best mask is the one you can wear all the time."

What's most important, she emphasizes, is compliance with existing mask guidelines — and recommitting to earnest and consistent mask-wearing.

If you do end up choosing to invest in a KF94 mask, Morse warns to be wary of counterfeits.

"Not all KF94 masks are made in Korea — many are manufactured in China — [but] KF94s manufactured in Korea may be less prone to counterfeiting," he says.

As COVID-19 continues to spread, researchers are looking for new and creative ways to help detect and manage cases. A team at the University of California San Diego is developing something to help do just that: a color-changing sticker.

The sticker is a test strip and blister pack that can be placed on N95, surgical or cloth masks and detect SARS-CoV-2 in the user's breath or saliva, according to a news release from the university.

As the person wearing the mask breathes, the test strip aims to detect protein-cleaving molecules produced from a COVID-19 infection. Once the user removes the mask and test materials, they squeeze out the contents of the blister pack onto the test strip. If the test strip turns a specific color, it means infection molecules are present.

The university says the test would be similar to that of a home pregnancy test, with the test strip having a control line that shows what a positive result will look like.

Jesse Jokerst, professor of nanoengineering at the UC San Diego Jacobs School of Engineering and lead principal investigator of the project, noted that the strips will not replace standard testing protocols.

"Think of this as a surveillance approach, similar to having a smoke detector in your house," Jokerst said in the news release. "This would just sit in the background every day and if it gets triggered, then you know there's a problem and that's when you would look into it with more sophisticated testing."

Jokerst and researchers at UC San Diego School of Medicine aim to test the strips on positive COVID-19 saliva samples before they're tested on patients and health care workers.

These masks feature four layers of non-woven fabric, elastic ear loops and an adjustable nose bridge for a tight fit.

For a NIOSH-certified N95 face, mask look no further than this option. Each mask is lightweight, flexible and features two cloth straps.

Made of five layers (two polypropylene non-woven layers, two meltblown filter cloths and one non-woven cotton middle layer), this mask also has an adjustable nose clip and a foldable, lightweight design.

This NIOSH-approved mask has head and neck loops for comfort, a cup-style design for good fit and flexibility for easy storage.