Mask Supplier Guidance Program Focuses on $60 billion Opportunity

ASTM Standards will be a Good Start Toward Better Masks

ASTM Standards will Provide the Baseline

Additional Measures to Prevent COVID Spread in Hospitals

ATI Chronicles Filter Tester Success At  8^th Filtration Asia Held Earlier this Month in Shanghai

U.S COVID Cases Surpass 17 Million

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Mask Supplier Guidance Program Focuses on $60 billion Opportunity

If six billion people began wearing tight fitting and efficient masks as many as one million lives could be saved in the next eight months.  If after the pandemic subsides people wear these same types of masks to protect against air pollution, wildfires, and other air contaminants a very large numbers of deaths and illness can be prevented.  The average person has two colds per year. If they just wore a courtesy mask while infectious more than 20 billion sick days could be avoided.

To accomplish this goal there needs to be an adequate supply of affordable masks.  Therefore reusable masks have to be the main type of masks utilized. The initiative will only be successful to the extent that people are willing to wear the masks for long periods. Comfort and attractiveness are also important to insure wear.  Comfortable, Attractive, Tight Fitting, Efficient and  Reusable are the benefits of CATER masks.

Suppliers of masks, media, and other components need to work toward a common goal of meeting as much of the market needs as possible. It will be difficult but not impossible to provide three billion masks at $30/mask in 2021. On the other hand providing two billion masks in 2023 will not be a problem when you consider that reusable masks require only 3% of the media required for disposable masks and that membranes and nanofibers as well as meltblowns can be utilized. 

McIlvaine is helping suppliers meet this common goal with a three step approach.

1.      Provide CATER Mask Decisions with comprehensive news coverage and analysis

2.      Help suppliers communicate the advantages of their products and services

3.      Assist with strategic and market analysis and forecasts

 

ASTM Standards will be a Good Start Toward Better Masks

Sheila Kaplan writing in the NY Times observes “More than 100,000 varieties of face masks are currently for sale. They come in silk, cotton. and synthetics; with filters and without; over-the-head and over-the-ears. They have sparkles and sunflowers; friendly greetings and insults; cartoon characters and teeny reindeer.

“What they don’t have is a label that shows how well they block infectious particles, an omission that has frustrated public health officials during the coronavirus pandemic. Those experts note that there is a big range in the effectiveness of various designs, and some barely filter out particles at all.”

She follows with another quote “By having a standard in place you will be able to know what level of protection is being achieved and you’ll have a consistent way of evaluating these products,” said Maryann D’Alessandro, director of the NIOSH National Personal Protective Technology Laboratory.

Sheila interviewed Linsey Marr who we have quoted many times. “A working group of federal and industry officials has proposed one high and one low filtration requirement that manufacturers and distributors can adopt and list on their labels. The lower standard is a 20 percent filtration barrier and the higher is 50 percent.

Those numbers are more protective than they sound. The filtration efficiency percentages are based on a product’s efficiency at filtering particles measuring 0.3 microns, which, as the generally most penetrative particles, are standard for NIOSH tests.

“Twenty percent efficiency at 0.3 microns would translate to 50 percent efficiency at one- to two-micron particles, and 80 percent efficiency at blocking particles that are four to five microns or larger,” Dr. Marr said. “I think it will be useful.”

McIlvaine would add to this discussion by pointing out that the most recent evidence shows most particles are emitted during breathing and are sub-micron droplets which result from a splash mechanism in the lungs. Furthermore as pointed out by UCSD and McIlvaine a droplet initially captured by the mask will evaporate or split. The result is smaller droplets or salts which are sub-micron in diameter

Shiela writes “Manufacturers who want to note that they meet the ASTM standard must first have their products tested by an accredited laboratory. They should also be able to show that their masks provide a reasonable fit to the population at large”

McIlvaine believe this requirement for testing by an accredited laboratory is a great step forward.  It opens the door for companies with 95% efficient masks to contrast their performance to the labeled products.  However leakage around a mask can be 50%. The requirement to self-test and provide evidence of a reasonable fit is equivalent to a statement that the mask does remove some particles.

McIlvaine recommends that readers access the CATER intelligence system and see how companies such as Vogmask are approaching the fit testing. First they are making it a top priority. Vogmask has five mask sizes to fit the various shape sizes. Many suppliers have two or less. Furthermore fit testing has been done by highly reputable institutions where measurements are taken of multiple subjects in various different modes (walking, bending, talking etc.). Vogmask is quick to point out that this testing was not to receive accreditation but only to establish relevant information

It is the goal in CATER Mask  Decisions to provide clarity relative to the performance of various masks.  Mask rating is already being done by many publishers.  If they have more credible resources such as CATER Mask Decisions  they can better advise their viewers. The same is true for nonprofit associations and governments. 

The NY Times article is creating quite a bit of interest and can be viewed at How Effective Is the Mask You’re Wearing? You May Know Soon - The New York Times (nytimes.com)

 

ASTM Standards will Provide the Baseline

The ASTM standards with 20% and 50% ratings will be a great starting point for buyers. It will show how efficiency is calculated and make people aware that the fit is equally important.  However just because a car meets minimum safety standards doesn’t mean the buyer is not interested in maximum safety.

The buyer will want to find the most Comfortable, Attractive, Tight Fitting and Efficient mask possible.  Cost will be an issue so the Reusable mask life will be of high interest.

In CATER Mask Decisions readers will be able to view the evidence and various different ways of rating masks. This effort is supplemental to the various standards and rating systems employed by governments and associations.

The leakage assessment in the draft of the ASTM standards is brief.

5.4 Leakage Assessment

5.4.1 The leakage assessment shall be reported by the manufacturer through a product design analysis self-declaration. 

5.4.2 The required self-declaration shall report that the product minimizes leakage around the edges or other areas of the product based upon an analysis of the product design. This statement can be included on any self-declaration required as part of Guide F3050, under Section 12 of this specification.   

5.4.2.1 The manufacturer is permitted to conduct quantitative testing to supplement its product design analysis self-declaration. When used, the leakage ratio shall be evaluated using Test Method F3407, with the modifications specified in 8.3.

5.4.3 Where barrier face coverings are reusable and intended for laundering or cleaning, the product design analysis shall be applied to barrier face coverings both in a new condition and after the maximum of laundering or cleaning cycles as specified by the manufacturer according to the manufacturer care instructions.

This language alerts decision makers to the importance of fit but as shown in the previous paragraphs there is a great deal of testing which needs to be done to quantify the leak risk. 

The standard also sets up two performance categories at 20% and 50%.

  

 

The following examples were calculated based on available information for various types of masks. The net efficiency equals the media efficiency less leaks.

 

The 20% leakage is possibly representative if there are limited mask sizes available and great care is not taken in the mask design. Without comprehensive fit tests it is logical to assign a number such as this.

As a result the ASTM 20 would have a net efficiency of only 16% vs 91% for the CATER 95.

 

Net efficiency is only important if the mask is worn continuously. The use of masks is greatly impacted by the breathing resistance. By subtracting the breathing resistance from the net efficiency, a basic performance rating is created.

The actual resistance may be less than 15 mm but that is what is specified as the maximum in the standards. This rating approach is not intended be used to set minimums but just as another way to view performance and the balance between efficiency and comfort. 

There is also the impact of both transmitter and recipient wearing masks.  If a person wearing a CATER 95 mask transmits all virus to the recipient also in the CATER 95 only 9% of the load reaches the recipient who in turn removes 91% or another 8% making the combined efficiency 99%.  The transmitter in an ASTM 20 mask will allow 86% to reach the recipient. The recipient  will only take out another 13% for a combined total of 29%. So in one case only 1% of the virus is being inhaled and in the other it is 71%. So one way to look at it is that the risk is 71 times as great if everyone wears an ASTM 20 vs CATER 95.

Additional Measures to Prevent COVID Spread in Hospitals

A variety of measures are necessary to prevent the spread of the coronavirus SARS-CoV-2 in hospitals and nursing homes. It is particularly important to develop an appropriate strategy to protect health care workers from airborne transmission. 

Researchers from the Leibniz Institute for Tropospheric Research (TROPOS) in Leipzig, the CSIR National Physical Laboratory in New Delhi, the Institute of Atmospheric Science and Climate (ISAC) in Rome, and 2B Technologies, Colorado, recommend that more attention is required in respect to indoor air in such facilities and to further training of the staff. 

From an aerosol experts' point of view, it is necessary to combine these different measures, the research team writes in an Editorial article in the International Journal of Environmental Research and Public Health. These include regular ventilation, controlling fresh air consumption via CO₂ monitor and using humidifiers to keep the relative humidity indoors at 40 to 60 percent. If it is not possible to ventilate sufficiently, the use of portable air purifiers is also advisable.

The risk of infection is particularly high in hospitals and nursing homes because infected and healthy people stay in the same room for long periods of time and the virus can be transmitted via invisible aerosol particles in the air, even over distances of several meters. According to media reports, COVID-19 infections are already reported in almost one tenth of the 12,000 retirement homes and nursing homes in Germany. Homes are now also considered as hotspot for the spread of the virus among new infections in Saxony.

Since the outbreak of the pandemic in early 2020, there have been increasing reports of transmissions via aerosol particles in the indoor air of hospitals and nursing homes. These include scientific reports from hospitals in China and the USA, but also from a nursing home in the Netherlands, where the virus apparently spread via the ventilation system using aerosol particles because unfiltered indoor air circulated in a ward. As further evidence, SARS-CoV-2 was detected on the dust filters of the air conditioning system there. 

"The complexity of the aerosol transmission of SARS-CoV-2, especially indoors, is far from being solved and there is a need to establish appropriate guidelines to protect medical staff. With this publication, we are therefore trying to give recommendations for measures that could contribute to the containment of not only current, but also future virus pandemics," reports professor Alfred Wiedensohler from TROPOS.

The aerosol spread of the virus is, according to many experts, a major reason why the number of coronavirus infections in Europe increased dramatically in the autumn. People stay indoors for longer durations and as temperatures fall, many indoor spaces are much less ventilated. Concentrations of viral particles in the air can rise sharply when infected people stay indoors. Simple mouth-nose masks can significantly reduce but not completely prevent the release of viral aerosol particles through the airways. The risk can therefore increase significantly with the number of people and the length of time they stay in the room. Hospitals and nursing homes are particularly affected by this, because additional risk factors are added there: particularly sensitive people, very long stays in a room, and sometimes medical procedures such as intubation in intensive care units, where a lot of aerosol is produced.

The spread of viruses via the room air can be reduced with a number of measures. However, there is no single measure that can achieve this completely, but it is important to control indoor air and combine different measures:

"As protection against the transmission of SARS-CoV-2 via the air in closed rooms, especially in cold and dry weather, we recommend humidifiers to keep the relative humidity in the room in the range of 40 to 60 percent and to reduce the risk of respiratory tract infection. It is in this middle range that the human mucous membranes are most resistant to infections. In addition, the viruses in the aerosol particles can survive at a relative humidity around 50 percent for less time than in drier or high humid air," explains Dr. Ajit Ahlawat of TROPOS.

It is very important that there should be a constant supply of fresh air through the air conditioning system or ventilation. This can be controlled with measuring devices for carbon dioxide (CO₂). The high CO₂ values in indoor places indicate that there is lot of exhaled air in the room. If there is an infected person in the room, then there would also be many viral aerosol particles floating in the air and could be inhaled by a healthy person. The heating, ventilation, and air conditioning (HVAC) system should have a minimum efficiency of MERV-13 to filter even very small particles out of the air.

If it is not possible to ventilate the room sufficiently, an attempt can be made to reduce the concentration of viruses in the room air by using air purifiers. However, these air purifiers should have so-called HEPA (high-efficiency particulate absorbing) filters. However, air purifiers can always only be an additional measure as they cannot replace the supply of fresh air and thus oxygen.

Medical staff need special protection during procedures and surgical operations that involve potentially infectious aerosol particles—such as dental treatment or intubation in intensive care units. Valve-free particle filter masks, so-called respiratory masks such as N95, should be worn and care should be taken to ensure that they lie close to the skin. 

"Avoid the use of FFP2 and FFP3 type respirators, which have an exhalation valve or ventilation, as these types of respirators are not sufficient. To reduce the risk, protective equipment such as goggles should also be worn," advises Dr. Francesca Costabile of the Institute of Atmospheric Science and Climate in Rome. In addition, the researchers recommend avoiding aerosol-generating procedures and treatments in patients with COVID-19 wherever possible to reduce the risk of infection for medical staff. Aerosol-generating treatments usually include medication administered via a nebulizer. In order to avoid the risk of aerosolization of SARS-CoV-2 by the nebulization process, inhaled drugs should be administered by a metered dose inhaler rather than a nebulizer, if possible.

Care should also be taken when disinfecting rooms: "We recommend that disinfection with UV-C light should not be used too often. Although it is known that UV-C light destroys the SARS-CoV-2 viruses, it ultimately increases indoor ozone concentrations and can thus have a negative impact on health if the indoor air is not adequately replaced," stresses Dr. Sumit Kumar Mishra of CSIR - National Physical Laboratory. Spraying oxidizing chemicals in the air, such as hydrogen peroxide (H₂O₂), can also have negative consequences. Indoors, these chemicals cause toxic chemical reactions that create other air pollutants and damage the central nervous system and lungs of humans.

The international research team emphasizes that the training of hospital and nursing home staff is extremely important to prevent the spread of viruses via indoor air. Medical staff must be adequately trained to follow the recommendations. It is important to draw attention to the risks of airborne transmission of SARS-CoV-2. Such recommendations, if adequately provided by health authorities and implemented by medical staff, could significantly reduce the risk of airborne transmission in hospitals and nursing homes until vaccination is effective on a large scale.

ATI Chronicles Filter Tester Success At  8^th Filtration Asia Held Earlier this Month in Shanghai

Air Techniques International (ATI), best known for its decades of experience as a leading designer and manufacturer of photometers and generators used in the clean air and containment industry, told visitors to its stand  that it was a record year of orders for the 100X Automated Filter Tester. 

The 100X Automated Filter Tester is used to test and validate filter media, cartridges, and masks used in medical and industrial hygiene applications. The 100X is designed to meet the precise and rigorous requirements needed by production, quality control, and R&D environments. 

U.S COVID Cases Surpass 17 Million

The United States on Thursday surpassed 17 million official Covid-19 cases across the pandemic, while a key meeting  could lead to authorization of a second coronavirus vaccine for the country.

Thursday's developments come as the US, while just starting to distribute its first authorized vaccine this week, is dealing with record rates of daily cases, daily coronavirus deaths and numbers of Covid-19 patients in hospitals.

Vaccine advisers to the Food and Drug Administration began meeting Thursday morning to discuss Moderna's vaccine candidate, and are expected to vote Thursday afternoon on whether to recommend it.

If the advisory panel does recommend it -- as it did for Pfizer's vaccine last week -- the FDA is widely expected to quickly grant emergency use authorization, which would free Moderna's vaccine for shipment.

The US Centers for Disease Control and Prevention would need to approve the vaccine before shots can be administered -- and a CDC advisory panel is expected to meet on the matter Saturday, raising the possibility that the Moderna vaccine could be used next week.

Hundreds of American health care workers have received their first dose of the Pfizer vaccine and many states have announced they're also expecting nursing home resident vaccinations to begin this week.

Wednesday saw grim numbers -- the highest Covid-19 infections and deaths the country has reported in a single day, and the highest number of Covid-19 patients in US hospitals on a given day.

More than 247,000 new cases were reported Wednesday. More than 113,000 Covid-19 patients were in hospitals, according to the COVID Tracking Project. And more than 3,600 people were added to the nation's death toll.

The country's total official case count stood at more than 17,000,400 on Thursday, according to Johns Hopkins University only five days after the count surpassed 16 million. But researchers have said the actual number of US infections -- counting those that weren't tested for -- probably is many millions higher.