CATER Mask Decisions

January 20, 2021

Webinar Agenda for Tomorrow

Speed is the Basis for the Webinar Tomorrow

A Push-Pull Program will Provide the Speed and Efficacy

Validation of Fitted Mask Efficiency Still will be Needed

Five Step Approach Needed

Eurofins has a Tested Quality Seal for Community Masks

ATI Supplies Both Mask PFE and Resistance Testers

Ambrust American Expands Meltblown Capacity

______________________________________________________________________________

Webinar Agenda for Tomorrow

Individuals are encouraged to present their views in the webinar tomorrow. The format will be to display the relevant material from previous Alerts in chronological order. We will then encourage discussion. People who have already committed to making comments are listed.

January 20, 2021

Speed is the Basis for the Webinar Tomorrow

A Push-Pull Program will Provide the Speed and Efficacy

Validation of Fitted Mask Efficiency Still will be Needed

Five Step Approach Needed

Eurofins has Tested Quality Seal for Community Masks

January 19, 2021

Join Us on Thursday to Debate the Mask Issues

Media Supply will be Substantial According to Dave Rousse

·         Dave Rousse

Mobile Device to Insure Selection of the Mask with the Right Fit

·         Keith Dellagrotta

Leveraging ASTM Label Initiative for Efficient Public Masks

·         Erich Couch

Breathing Resistance, Filtration Efficiency and Media Area

FFP 2 Masks Now Required in Retail Stores and Public Transport in Austria and Germany

January 18, 2021

Sufficient Essential Braces can be Supplied to Meet Needs

·         Sabrina  Paseman

Quick Fit Testing Methods are Needed- How About Thermal Imaging?

Some Thermal Imagers Already Recognize Face Masks

How About the Temperature Scanners Presently Being Used

January 15, 2021

Biden Mask Mandate Debate Next Thursday - Join the Discussion

·         Chance for anyone to weigh in on any of the issues

Review of Coronavirus Mask Decisions

the webinar will be recorded and available to view in the webinar section of CMD.  To register for the event click on http://www.mcilvainecompany.com/CATER/subscriber/default.htm

Speed is the Basis for the Webinar Tomorrow

In his inauguration speech this morning President Biden spoke of speed and urgency in dealing with COVID. He needs to know as quickly as possible whether mask efficiency should be a major factor in reducing COVID spread. The goal of the webinar tomorrow is to help accelerate the communication and decision making. 

It is logical to ask why has McIlvaine undertaken what would logically be the province of an association or government body. The answer is speed. McIlvaine has proven in past crises that it can make a contribution when quick decisions have to be made about air and water issues.

At the time of the Gulf oil spill decisions had to be immediately made as to whether chemical or non-chemical O2 sensors would be used in the undersea drones to chart the oil spill. McIlvaine  organized a series of webinars in just a few days. Experts, operators and governments shared valuable insights.

EPA was within days of  promulgating the 1990 power plant air regulations when it was discovered that all three methods for velocity measurement had flaws. A series of McIlvaine webinars including EPA, power plants, consultants, and suppliers provided the needed answers.

A failure of 2205 nickel alloy SO2 scrubbers resulted in many hours of webinars in just a few weeks as solutions were pursued for what turned out to be a multibillion dollar problem.

A Push-Pull Program will Provide the Speed and Efficacy

Erick Couch, tomorrow, will be advocating that the Biden Administration mandate or endorse ASTM labels which would specify performance in either the 20-50% range or 50-100% range.  He will further emphasize that this range can be the basis for further effort. The ASTM label can be conceived as the Push effort in a two part push-pull sequence.

In the push-pull concept you want to minimize  Push  e.g. “require” and to maximize  Pull e.g. “incentivize ”.

.

What incentives do individuals, universities, fitness centers, and malls have to require something more than the ASTM 50-100 label? The answer is survival.  Let’s say occupancy and mask efficiency are directly proportional. As a theater operator would you rather have 50% or 100% of the seats filled.

The basic requirement  for anyone in public space can be the ASTM 50-100 in the U.S. In Europe it will be the tough regulations already in place (see below). In addition there can be safe bubbles where efficiency requirements higher than 50% are the price of entry. Europe has 70% and 90% efficiency levels. When people understand that 90% + 90% x 10% = 99%  whereas 70% + 70% x 30% = 91% and that the virus risk is nine times lower with the 90% masks there will be many safe bubble operators who will opt for the higher efficiency. If the hotel down the street has a 90% bubble the other hotels will want to offer the same level of  safety.

The “Pull” safety level can be validated by a seal similar to the Eurofins “Tested Quality Seal” shown below. Eurofins with many thousands of employees around the world is well positioned to create a seal which the public will recognize.

SGS is another large organization which could create its own seal. A few organizations with international reach can create competing seals. A mask could carry both the ASTM 50-100 label and the Tested Quality Seal which would show a specific level of efficiency e.g. 90%.

The Tested Quality Seal validates not only the theoretical performance of a mask but the adherence to quality control throughout the manufacturing and distribution process. The quality control problems with a number of Chinese masks demonstrates the need for quality control validation.

Do we create a monopoly for a few large organizations such as Eurofins or SGS? We can avoid this by having sufficient numbers of Tested Quality Seal providers. A large testing organization such as Nelson Laboratories can elect to partner with quality control capabilities such as MPR and create an alternative Tested Quality Seal.

Validation of Fitted Mask Efficiency Still will be Needed

Some mask companies such as Vogmask have five different sizes and spend a lot of time making sure customers wear masks properly. Keith Dellagrotta will be speaking tomorrow about using the iPhone for a facial scan and then analysis of the Vogmask fit. We also asked Keith about the broader use for people entering a facility. He replied “As an ER doctor, I am very familiar with the annual N95 fit test requirement by OSHA. Our technology involving just the facial scan and virtual overlay of the mask would be simpler and much less subjective. We have not pursued this pathway yet but it remains on our radar.”

Our recent Alerts have pursued thermal imaging at entrances as a way to validate mask fit.  Alternatively just a visual inspection may be an option. Mask fit inspection will be both difficult and politically challenging. But with reference to our automobile safety analysis in the previous Alert it is achievable. It may take time. After all seat belts were only required decades after people started driving.

On the other hand operators of safe bubbles will not want to take chances. A restaurant is less worried about being shut down for sanitary violations than it is in sickening a number of people and creating damage to its public image.

Five Step Approach Needed

Success depends on a five-stage sequence. Mask quality has to be addressed starting with manufacturing and ending with the final fit inspection.

Fit Inspection will be the last step in a process which will insure efficient masks for everyone.  the process has built in flexibility. Much of it can be implemented immediately. Other parts will need to be improved over time.  Since speed is crtical the five step process is a route which will most quickly accomplish the objectives

Eurofins has a Tested Quality Seal for Community Masks

Eurofins provides high-standard quality assurance and control services throughout the supply chain.

Manufacturers are responsible for ensuring that the masks they supply and put on the market comply with safety and effectiveness requirements and the standards required in the country in which they are sold. Eurofins laboratories are ISO/IEC17025:2017 accredited for Particulate Filtration Efficiency testing (PFE), Bacterial Filtration Efficiency testing (BFE) and differential pressure (breathability), delivering precise, reliable and accurate testing results to customers for EN, ISO and ASTM test methods. Another important consideration is the information made available to consumers at the point of purchase. Well-designed product specifications and claims help to ensure that the user can easily and correctly access, understand and use the mask. Eurofins offers check service for marking, labelling and instructions of use, according to the recommendations by the national Authorities.

Tested Quality Seal

In an effort to provide  clients with proof of compliance for hygienic masks, Eurofins experts have developed the Tested Quality Seal for Community masks, which will be granted to masks meeting the thoroughly designed testing protocols.

Quality Assurance and Control throughout the Supply Chain: Whatever the role in the supply chain, it’s important to safeguard the reputation of the brand and/or that of the client. From suppliers’ assessments and R&D support to regulatory guidance and supply chain mapping, all the way through to compliance and bespoke testing, QC inspections, failure analysis and market surveillance, Eurofins cover every stage of the product’s quality journey.

Marking checks on labels, packaging and instructions for use: Marking on the product, whether directly or on a label, and/or on its packaging and instruction manual, is mandatory and must be displayed in the applicable official domestic language(s) and observe the wording as defined in the country-specific legislation. Eurofins’ label and marking check service includes: • Completion of name, trademark, address and contact details of the responsible actor (producer or importer) • Product batch ID (whenever applicable) • If tested against the CWA document: “Community face coverings CWA”, followed by the version of the CWA document concerned • The filtration efficiency level, method used and standard • Durability i.e. reusable or disposable • Targeted user age e.g. child or adult • Restriction warning e.g. “Not suitable for children under 3 years of age”.

Eurofins  experts have developed the Tested Quality seal for Community masks, which will be granted to masks meeting the thoroughly designed testing protocols

The specific requirements in Europe and individual countries are shown below.

Details on other European regulations are also provided on the Eurofins site at  https://cdnmedia.eurofins.com/corporate-eurofins/media/12153917/ef-brochure-community-masks-en.pdf

ATI Supplies Both Mask PFE and Resistance Testers

Mask Particle Filtration Efficiency (PFE) Tester is used to test the particle filtration efficiency (oil or non-oil particle) of face masks, mask raw fabric (meltblown non-woven), results in percentage level, such N95 means 95% filtration level.

Mask Respiratory Resistance Tester adopts a replaceable head-shape model, can test varied mask sizes for adults or children; Equipped with a high-quality flowmeter providing steady airflow, which increases the accuracy of the resistance testing results.

SPECIFICATIONS:

• Air source: air compressor
• Flowmeter range: 0L/min ~ 100L/min, accuracy is ±2%.
• Micro-pressure measuring range: -1000Pa～1000Pa, precision 1Pa
• Pump capacity requirement: ≥100L/min
• Constant ventilation volume: (85±1)L/min
• Display mode: touch screen display
• Test time: As required, adjustable
• Automatically record the test data: Yes
• Power supply: AC220V±10%, 50Hz, 0.6KW

Ambrust American Expands Meltblown Capacity

With first responders across the country suffering from shortages, PPE manufacturer Armbrust American today announced that its factories are now capable of producing meltblown, the non-woven fabric material that is crucial to filtering out microscopic particulate matter such as the coronavirus.

Armbrust American's Texas-based medical mask facility & meltblown machine.

In 2019 less than 3 million tons of meltblown material was produced in China, which isn't enough to manufacture a sufficient supply of PPE like surgical and N95 respirator masks. The move to produce its own meltblown allows Armbrust American to control costs and better scale its operations so that America's first responders have the protection they need.

"Nine months into this pandemic, a lack of domestic manufacturing is the only explanation for why America still does not have enough PPE," said Founder and CEO Lloyd Armbrust.

"Investing to produce our own meltblown means we aren't dependent on other countries, who are more than willing to profit from our lack of preparation."

Meltblown is made from plastic polypropylene pellets that are melted down and "blown" into a nonwoven fabric sheet, which then gets a static charge to improve filter effectiveness. The majority of meltblown material is manufactured in China and sold to U.S. manufacturers at a great cost. This has caused prices for PPE to skyrocket, with some health service providers now passing those exuberant expenses to patients in the form of surcharges, according to recent reports.

"PPE prices skyrocketed globally during this pandemic because China controls the supply, and the situation is scarcely better today. So when demand for PPE rises, America is once again at their mercy, unable to deliver products and held hostage to rampant price gouging," said Armbrust American President Landon Morales. "We can't rely on other countries to supply masks. America needs to take care of itself."

Armbrust is manufacturing a new Electrostatic Armor ® Meltblown, the company's new proprietary blend of meltblown filtration material that more easily adds a static charge and allows those wearing a mask greater breathability. Despite the premium quality and proprietary process, the company is still able to keep costs lower than what is sold from China.

"The shortage has caused people to rely on reusable cloth masks that offer as little as 10% protection against the coronavirus. And now our hospitals are subsidizing Chinese companies to produce something that can be made better and cheaper at home," Armbrust said.