CATER Mask Decisions

February 9, 2021

Capability to Provide Efficient Masks to all Americans

The Opportunity is Huge and Many Lives will be Saved

Request from Eric Couch for Submittal to OSHA

Capabilities of U.S. Mask Makers to Expand Production

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Capability to Provide Efficient Masks to all Americans

The Opportunity is Huge and Many Lives will be Saved

Coronavirus Mask Decisions has long been stating that tight fitting efficient masks can halt the pandemic. The medical community has now come to the same conclusion. The average mask worn in public as shown in a Patient Knowhow survey is only 20% effective. So an immense change in mask type is needed.  ASTM has worked hard on efficacy standards which it will publish next month. Two levels of efficiency are specified. More importantly the standards will provide a measurement structure by which the most effective masks can be selected.

The Biden Administration is committed to masks as a solution. Several different agencies are involved in shaping the government initiative. There is the potential for minimum efficacy standards and for government funding. The following is an email regarding how suppliers can interface with government agencies to achieve the desired results.

It is followed by an analysis prepared by McIlvaine and then background information from mask suppliers.

Comments are being solicited from mask suppliers. This Alert along with mask supplier comments will be submitted by McIlvaine to Erich Couch and INDA for further submission to OSHA.

Request from Eric Couch for Submittal to OSHA

Eric Couch is working on the quick supply of efficient masks to  everyone and is coordinating efforts with various government agencies. There is the opportunity to obtain government endorsement of minimum efficiency levels and to also receive some funding. Here is what he emailed us this morning.

“Truly time sensitive as OSHA input is critical and due, summarized, by this Thursday...hence request for input by end of day tomorrow.  

Can you please assist in getting the word out to the elastomeric mask fabricator community?  Dave (Dave Rousse of INDA) already has the nonwoven fabric industry covered so this focus is exclusively the elastomeric higher level assembly fabricators.

·         Summary: (see below)

·         Deadline: Wednesday, Feb 10^th

·         Critical window of opportunity (this week) to secure OSHA “incorporation by reference” of the ASTM Face Covering Standard. 

·         Advisory Panel Developing Assessment of US Capacity (Filter and  Conversion) which will be provided to OSHA. OSHA cannot implement an Emergency Standard if there is inadequate supply or if the supply is limited to a few vendors. 

He requested the following information. 

1. What is their current monthly production, in million (m/m);
2. What is estimated monthly production by May 15, 2021; and
3. What could their monthly production be by May 15, 2021 with government funding.
4. If possible, estimate order of magnitude of needed funding as we will attempt to facilitate Title III funding support. 

Title: URGENT: OSHA Mar 15 Emergency Standard / Quality Masks / ASTM Face Covering Standard

Objective:

·         Develop support within Biden Administration and CDC

·         Address misunderstandings around ASTM Standard, supply, breathability, and fit.

Summary:

President Biden has issued an Executive Order directing OSHA to consider whether any emergency temporary standards on COVID-19, including with respect to masks in the workplace, are necessary, and if such standards are determined to be necessary, issue them by March 15, 2021.  Face coverings are a topic of concern, particularly given the recent public debate around double masking and overall mask quality and fit.  OSHA is likely to either recommend adherence to current CDC guidance (two or more layers and covering the mouth and nose) OR it could require face coverings made to the ASTM Barrier Face Covering Standard.  If OSHA requires face coverings to meet the ASTM Standard, it could also require minimum specifications for tests included in the standard, such as::

·         Minimum Filtration Level “X”

·         Minimum Breathability “Y”

·         Minimum Fit “Z”

To secure support within OSHA, the CDC, and Biden’s Administration for the widespread adoption of the ASTM standard in order to improve the protective value of face coverings, we need all parties to assist in mustering political support, and in correcting misunderstandings which are prevalent in the public conversation.

(NOTE: As ASTM approaches release of the standard,  a panel has been convened of recognized Aerosol Transmission Experts in conjunction with the Nonwovens industry (makers of the filtration media) to make recommendations on the specific performance levels that will ensure both the highest protection value and a robust marketplace capable of providing a adequate and reliable supply of ASTM compliant face coverings.

Misunderstandings to Correct:

ASTM Standard is Either 20% or 50% Filtration: This is inaccurate. The standard requires actual filtration test results be submitted. In an attempt to simplify public understanding, two ranges are identified, 20%-50% (Level 1) and 50%-100% (Level 2). It is true that minimum labeling requirements only mandate indication of which range a given mask meets, however, numerous example labels in the Appendix illustrate clear identification of the exact performance level (i.e. 80%). To address this unfortunate construct, OSHA and CDC will need to stipulate exact performance levels and any mask vendor will be compelled to indicate the exact performance level achieved. Here is a label that meets the minimum labeling standard and also provides performance levels against the key benchmarks (N95, Cloth, and Surgical Style)

(NOTE: Suggestion to indicate Surgical Style at 40% filtration & leakage)

Adequate Filter Media Supply beyond Frontline Responders: While the US has rapidly increased fine fiber meltblown nonwoven capacity (e.g., N95 capable) to meet medical frontline responder needs, there is inadequate supply of this high performing filter material to meet the needs of the extended worker community and general public. However, there does exist adequate capacity to deliver filtration that approaches that of the N95 to serve the entire extended worker community and general public without affecting supply to medical frontline responders. There are three sources of materials for the extended worker and general public scope:

·         Excess Meltblown N95 material

·         New Materials (i.e. NC State Nonwoven Institute Spunbond Material)  being developed

·         Extensive Capacity of Other Nonwoven Materials That Approach N95 Performance.

Rapid Production Capacity:

·         Elastomeric Mask Housings: While disposable US N95 conversion equipment is constrained (cost and lead time), by emphasizing elastomeric designs which can readily be scaled up by duplicating existing injection molding tooling ($20K-$100K / tool) and engaging the extensive injection molding machines within the US, supply is unconstrained.

·         Flat Filters: While formed disposable mask fabrication is highly constrained, flat filter fabrication can readily be accomplished with existing nonwoven equipment lines (i.e. from the upholstery industry). Flat layers are assembled, welded, and cut to shape. The welding / cutting tools can be replicated for $100K. It is worth noting that flat filters in elastomeric masks tend to use less material and last longer in comparison to disposable N95 respirators.

·         Pleated Surgical Style “Non-medical” Masks: At the beginning of the pandemic, the US had ~ 12 companies producing disposable formed N95 respirator masks. In response to the crisis, approximately 24 companies entered the market yet elected to setup factories to produce the surgical style pleated face coverings. There is adequate US capacity to immediately supply both the extended worker and general public demand. While pleated surgical style masks are normally for splash protection, and do not make an effective seal (~ 40% effective particle filtration), many models are actually made with filtration material that can achieve very high levels (~ 95%) if they are sealed to the face using a secondary elastomeric harness such as the “Fix the Mask” brace.

·         Surgical Mask “Fix the Mask” Brace: This simple solution is made of medical grade silicone using compression molding.

·         Fit & Breathability: The ASTM standard was deliberately developed to improve breathability. Recognizing that workers and the public may wear such protection for the entire workday, the breathability performance criteria, in millimeters of H2O of pressure resistance, was set at a challenging level of 5 mmH20 or less.  In actuality, a comfortable range is 5-10 mm H20.

Reply to Couch Request

QUANTITY AND COST OF MASKS NEEDED The majority of N95 and surgical masks are being supplied to 3% of the population (10 million people) whose mask use in three times greater than  the next more active group and 15 times greater than the majority of people inhabiting public space. This ratio is a function of viral load and numbers of hours  of exposure to that load. this can be considered as “relative mask duty”. One extreme is the nurse in an isolation ward. At the other is the individual who is only in public space when at the store. This present group of 10 million can be labeled as the “present target”

Some masks are designed to be reusable for up to 30 days without filter inserts. Others are designed to last even longer periods with periodic filter inserts. Some filters with long life cost more than $30.  However the cost per daily use can be less than $1. In contrast someone may be wearing several surgical masks per day.

Approximately three times as much relative mask duty will be needed for the public as presently needed by the present target (medical workers, first responders, and those with industrial exposure).

If this mask duty is primarily supplied by surgical masks with braces it is possible that the public numerical requirements will be three times those of the present N95/surgical mask  users. 

On the other end of the spectrum where the relative mask duty is supplied by reusable masks which last 10 times longer per unit of relative duty, then the public mask numerical needs are only 30 % of those of the present target.

So in terms of numbers we are talking about a range for the public of 0.3 to three times the present target. However in terms of material consumption there is more media and other components in the reusable masks. So the amount of material will range from one to three times.  The cost per unit of relative mask duty will be similar. So fitting the public with effective masks will cost three times what is being spent on the present target.

RATE AT WHICH PRODUCTION CAN BE INCREASED  Media availability is a limiting factor on production increase.  However, some mask suppliers such as Vogmask have designed their masks so that meltblowns are just one of many layers. The result is that the meltblown layer is better protected and lasts longer.

Other mask makers use materials other than meltblown media. There is no shortage of media if  limits on resistance are nor too strict. The amount of filterable media can be varied. Resistance varies as the square of velocity. So a slight increase in available media reduces mask resistance.

As long as cloth masks are allowed in public space, there is little incentive for rapid expansion of tight fitting efficient masks. As soon as this changes and the demand is clear, there could be rapid expansion. It is also likely that some of the large companies supplying cloth masks could switch to making tight fitting efficient masks. So we are not talking about increases in numbers of masks as much as we are increases in the number of effective masks.

THE IMPACT OF GOVERNMENT SUBSIDIES Expenditures by the government are best delivered as coupons and not vouchers for masks or for purchase and delivery of free masks. The reason is that the choice may be a 30 dollar mask rather than one for 2 dollars. If a number of coupons are provided they could be used on one or multiple masks.

With the coupons the market for the masks is increased and in effect assured. If the coupons can only be used for effective masks, the mask suppliers will be willing to spend the money to expand.

Capabilities of U.S. Mask Makers to Expand Production

Respirator suppliers also have public mask versions. MSA, 3M and Honeywell all have public mask versions.

Armbrust American is capable of gearing up to manufacture billions of masks and now even has its own meltblown media manufacturing. The company has been adept at buying equipment and moving to production very quickly. Many articles about the company appear in the Alert. There is also a recorded interview.

TAIJI Medical Supplies Single-Use Face Masks Designed to be Protective and Comfortable

TMS occupies a 120,000 sq ft facility in Lincolnton, NC that is already producing volumes of masks and will scale to millions. Masks can be made for nearly the same price as those made in China. TMS believes America should not have to choose between quality and price in a time of need.

TMS has two (2) melt-blown fabric machines in-house. Melt-blown fabric is the center layer of each mask and is what provides filtration. Many manufacturers were hindered during the height of the pandemic as they rely on sourcing from overseas. 

The company says it has combined automation, vertical integration and American ingenuity to solve the problem

Medical-grade surgical and protective face masks are designed, developed and produced end-to-end in America (Lincolnton, NC).

Twenty fully-automated assembly lines can produce thousands of masks per minute.

The vertically integrated factory takes raw polypropylene and transforms it into surgical and protective face masks in seconds.

Cummins and Dupont are Working Together to Help Address the Current Shortage of N95 Masks  According to Amy Davis, Vice President of Cummins Filtration, with many of the world’s leading mask manufacturers in need of the critical materials to assemble the masks and struggling to meet demand, Cummins will use pre-existing filter technology in partnership with DuPont to help fill the supply void. 

"Cummins is re-evaluating our supply base and manufacturing capabilities to identify how we can support our healthcare professionals who rely on critical personal protective equipment to do their jobs," Davis said. "Our NanoNet® Media can fill a key supply void and help address the mask shortage facing the United States and other countries around the world." 

The project also aims to provide open source instructions that other healthcare systems and groups can use to create their own respirator masks.

Cummins’ NanoNet® and NanoForce® Media technology, which uses DuPont’s Hybrid Membrane Technology (HMT), can typically be found in air, fuel and lube filtration products used in heavy-duty diesel engines to prevent long-term engine wear, but also can be used in the N95 respirator masks worn by healthcare professionals to filter harmful airborne particles that can spread COVID-19. 

Vogmask is a U.S. based supplier with expandable supply capability. Vogmask has spent nine years to achieve maximum comfort, attractiveness, tight fit and efficiency of its masks. There are many articles on Vogmask in the alerts and presentations in the McIlvaine webinars.

NXT Nano can Ramp Up to Meet Future Demand Quickly. These are excerpts from the McIlvaine interview with Andy McDowell of NXT Nano

1.      How fast can they ramp up production of high efficiency media?

2.      How flexible is a line to make mask, HVAC, microfiltration, or other media?

3.      How much time does it take to change a line over to make a different product?

We talked to Andy McDowell, director sales and marketing at NXTNano of Nano.  In the Alert we covered their mask making activities and also the extent of the use of their media for gas turbine intake filters, HVAC, masks and microfiltration.

Andy gave some very useful answers to our questions.

Bob:  Andy how long does it take to build a new line?

Andy:  Only 3 to 4 months and since we have to install humidity control and other basic services it is even easier to install multiple lines rather than just one.

Bob:  Can you give us some idea of the production of one line?

Andy:  If we are making masks and working 24-7 it is 86,000 m2/day.  If we are making HVAC media it is about 30% more.

Bob:  How many masks can be produced per m2?

Andy: About 40 surgical grade masks or 30 N95 grade masks.

Bob:  How many HVAC filters can be produced per m2?

Andy:  It varies but a rule of thumb would be 1 filter/m2.

Bob:  How much time does it take to change over from one product to another?

Andy:   We can make the change from one product to another in a matter of minutes not hours.

Bob:  We  see a big opportunity for the filtration industry to take a positive rather than negative attitude and say we can  invest in the production equipment necessary to see that everyone can be protected by wearing high efficiency masks and spending time in space that is filtered to remove viruses.  Do you think your company is capable of making major expansions?

Andy:  We just expanded capacity and do not see  major obstacles in expanding as warranted.