Coronavirus Technology Solutions

April 29, 2020

Sterilucent has Authorization from FDA for H2O2 Sterilization of Masks

Viruses Released to the Air While Doffing PPE

Minimum Dose and Viral Load are Crucial Factors

Reverse Engineer a Semiconductor Cleanroom

Masks with Valves have Advantages but Design and Maintenance are a Challenge

Coronavirus Detected on Air Pollution Particles

Trump  Orders Meat Processing Plants to Stay Open

Leprino Foods Shuts Dairy Food Plant Due to Virus

Air Showers are a Way to Reduce Virus in Locker Room Areas

Converting Patient Rooms to Negative Pressure Isolation

Mecart Providing Modular Isolation Rooms to Hospitals

Puracore COVID -19 Containment Modules Immediately Available

What Level of Filtration is Necessary?

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Sterilucent has Authorization from FDA for H2O2 Sterilization of Masks

The U.S. Food and Drug Administration has granted Sterilucent, Inc. (Minneapolis, MN), an Emergency Use Authorization to allow the emergency use of the Sterilucent™ HC 80TT Vaporized Hydrogen Peroxide Sterilizer for decontaminating single-use compatible N95 and N95-equivalent respirators.

Test results have demonstrated that filtering facepiece respirators may be reprocessed for use during the COVID-19 pandemic in the HC 80TT Flexible Cycle up to 10 times without a detrimental impact on filtration performance or a significant reduction in respirator fit. The system can reprocess up to 12 respirators at a time.

“We are glad to be able to help extend the safe use of PPE for healthcare staff during this time of overburdened supply chains,” said Chief Operating Officer Stephen Loes. “The HC 80TT sterilizer can provide timely internal turnaround of PPE that helps extend a facility’s inventory and better manage supply disruption or unavailability. Unlike other systems that deliver fixed amounts of chemistries for all load sizes for the selected cycle, the HC 80TT Cycle Guardian™ technology dynamically adjusts delivery of the sterilant needed based on the load in the chamber. The N95 load is light and, therefore, the HC 80TT sterilizer delivers less chemistry, resulting in less degradation of the respirator and lowering the cost per cycle for the facility.”

3M provides a regularly updated Technical Bulletin that discusses the CDC COVID-19 guidelines for decontaminating N95 respirators. The bulletin includes systems acceptable for mask reprocessing and those to avoid. The Sterilucent HC 80TT sterilizer is listed in Table 1, which summarizes the effects of decontamination methods on 3M respirators.

Details on the Sterilucent guidelines by FDA are shown at

https://www.fda.gov/media/137170/download

Viruses Released to the Air While Doffing PPE

At two hospitals in Wuhan, China, researchers found bits of the virus’s genetic material floating in the air of hospital toilets, an indoor space housing large crowds, and rooms where medical staff take off protective gear. The study, published Monday in the journal Nature Research, didn’t seek to establish whether the airborne particles could cause infections.

People produce two types of droplets when they breathe, cough or talk. Larger ones drop to the ground before they evaporate, causing contamination mostly via the objects on which they settle. Smaller ones - those that make up aerosols - can hang in the air for hours.

The researchers, led by Ke Lan of Wuhan University, set up so-called aerosol traps in and around two hospitals in the city that was home to the pandemic’s first steps.

They found few aerosols in patient wards, supermarkets and residential buildings. Many more were detected in toilets and two areas that had large crowds passing through, including an indoor space near one of the hospitals.

Especially high concentrations appeared in the rooms where medical staff doff protective equipment, which may suggest that particles contaminating their gear became airborne again when masks, gloves and gowns are removed.

The findings highlight the importance of ventilation, limiting crowds and careful sanitation efforts, the researchers said.

Minimum Dose and Viral Load are Crucial Factors

Infectious respiratory diseases spread when a healthy person comes in contact with virus particles expelled by someone who is sick — usually through a cough or sneeze. The amount of particles a person is exposed to can affect how likely they are to become infected and, once infected, how severe the symptoms become. This observation by Alex Hogan is included in a good article on virus load and minimum dose.

The amount of virus necessary to make a person sick is called the infectious dose. Viruses with low infectious doses are especially contagious in populations without significant immunity.

The minimum infectious dose of SARS-CoV-2, the virus that causes Covid-19, is unknown so far, but researchers suspect it is low. “The virus is spread through very, very casual interpersonal contact,” W. David Hardy, a professor of infectious disease at Johns Hopkins University School of Medicine, told STAT.

A high infectious dose may lead to a higher viral load, which can impact the severity of Covid-19 symptoms.

Viral load is a measure of virus particles. It is the amount of virus present once a person has been infected and the virus has had time to replicate in their cells. With most viruses, higher viral loads are associated with worse outcomes.

The more viral particles that get into the lungs, the more damage to the lungs that is probably happening,” said Hardy.

One study of Covid-19 patients in China found that those with more severe symptoms tended to have higher viral loads.

“It’s not proven, but it would make sense that higher inoculating doses will lead to higher viral loads, and higher viral loads would translate into more pathogenic clinical courses,” said Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.

People with higher viral loads may also shed more whole viruses, which makes them more contagious, compounding the danger of spreading disease more widely.

If exposure to higher doses, or even frequent low doses, of SARS-CoV-2 does lead to worse health outcomes, there are significant implications for health care workers who are routinely exposed to Covid-19 patients.

“Someone caring for large numbers of patients on the wards, if they’re not wearing PPE [personal protective equipment], there might be a high frequency of exposure as well as a high dose of exposure,” Barouch said.

In Italy, a country particularly hard-hit by the virus, about 9% of reported cases were health care workers. In the U.S., 10% of Covid-19 cases in California were health care workers, according to the California Department of Public Health.

Reverse Engineer a Semiconductor Cleanroom

Coronavirus Technology Solutions are available to allow us to safely return to semi normal routines but they involve masks instead of social distancing, foot sanitizers and many other technologies which are common practice in cleanrooms. No pharmaceutical cleanroom would be without an air shower in the room set up to put on cleanroom clothing,  The opposite should be true in a hospital where you are protecting the wearer rather than the product. So the reverse engineering of technology perfected for semiconductor and pharmaceutical cleanroom should be utilized.

In a semiconductor cleanroom the air quality is limited to one small particle per ft³ while the best hospital operating room is 10 particles and most are well over 100. Most areas of the hospital will exceed 100,000 particles per ft³ and 500,000 particles is typical which is also the average for ambient air in the U.S.

Masks with Valves have Advantages but Design and Maintenance are a Challenge

Paul Gardner, former chief of the Army's Edgewood Chemical Biological Center (ECBC)  Respiratory Protection Branch was asked by McIlvaine to use his experience in evaluating new filter media for the Army and comment on recent coronavirus needs. His analysis was included in the April 27 Alert.  He discussed challenges such as the higher breathing resistance, moisture, and comfort concerns.  So we asked Paul to comment on the use of masks with valves which eliminate some of these challenges. Here is his response.

Paul: The obvious benefit of exhalation valves used in some FFRs is that they reduce the exhalation resistance and moisture within the mask thus improving overall comfort.  As you mentioned, they are suitable for protecting the wearer as opposed to those around you should you be contagious. 

One tradeoff is the added expense to manufacture. The biggest downside, however, is that they are potential leak sources and in a reusable FFR would need to be checked and maintained after each use to ensure they are free of contaminants and functioning properly. There is the added risk that people will not perform the maintenance to ensure the valve is clean, undistorted, and seated properly.

I have seen flapper valves in half-mask air-purifying respirators that had hair or bits of paper towel from cleaning that caused them to leak.  Some were missing completely or stuck open having been sucked behind their spider support from heavy breathing.  Most of the flapper valves I have seen in disposable N95 FFR are very thin and not very robust but are well protected behind a non-removable housing (cover) and not intended to be serviced.  There are much higher quality outlet valve assemblies in elastomeric half-mask respirators which are can be serviced.  These types I believe would be more suitable for a reusable FFR.  However, in my mind none would lend themselves particularly well to washing, assuming that was the primary method used to decontaminate/reuse the masks, unless the entire assembly or flapper valve could be removed easily before washing the facepiece covering and/or filter (if separate) and reinserted without compromising the seal of the valve assembly and/or the flapper valve. 

In summary, I see the benefit of exhalation valves in “single or limited use (i.e.,  disposable) ” N95 FFRs but due to the concerns mentioned above not so much for “long-term or extended use (i.e., reusable) ” FFRs, at least those that would need to be cleaned (washed) and maintained.

I would like to summarize my opinion in the positive:  I believe exhalation valves would be a beneficial and desirable feature for a “reusable” N95-equivalent FFR intended for extended use by the general population.  That is, if the mask can be designed to be maintained by the user (properly cleaned) without compromising the performance of the mask, especially with regards to the exhalation valve. 

Coronavirus Detected on Air Pollution Particles

Coronavirus has been detected on particles of air pollution by scientists investigating whether this could enable it to be carried over longer distances and increase the number of people infected.

The work is preliminary and it is not yet known if the virus remains viable on pollution particles and in sufficient quantity to cause disease.

The Italian scientists used standard techniques to collect outdoor air pollution samples at one urban and one industrial site in Bergamo province and identified a gene highly specific to Covid-19 in multiple samples. The detection was confirmed by blind testing at an independent laboratory.

Leonardo Setti at the University of Bologna in Italy, who led the work, said it was important to investigate if the virus could be carried more widely by air pollution.

“I am a scientist and I am worried when I don’t know,” he said. “If we know, we can find a solution. But if we don’t know, we can only suffer the consequences.”

Two other research groups have suggested air pollution particles could help coronavirus travel further in the air.

A statistical analysis by Setti’s team suggests higher levels of particle pollution could explain higher rates of infection in parts of northern Italy before a lockdown was imposed, an idea supported by another preliminary analysis. The region is one of the most polluted in Europe.

Previous studies have shown that air pollution particles do harbour microbes and that pollution is likely to have carried the viruses causing bird flu, measles and foot-and-mouth disease over considerable distances.

The potential role of air pollution particles is linked to the broader question of how the coronavirus is transmitted. Large virus-laden droplets from infected people’s coughs and sneezes fall to the ground within a meter or two. But much smaller droplets, less than 5 microns in diameter, can remain in the air for minutes to hours and travel further.

Experts are not sure whether these tiny airborne droplets can cause coronavirus infections, though they know the 2003 SARS coronavirus was spread in the air and that the new virus can remain viable for hours in tiny droplets.

Trump  Orders Meat Processing Plants to Stay Open

Faced with worries of a meat shortage caused by the coronavirus, President Donald Trump has ordered meat processing plants to remain open and will try to protect them from legal liability, officials said Tuesday.

Trump declared meat plants as critical infrastructure and cited the Defense Production Act to justify an order to keep them open, said two officials familiar with the discussions, speaking on condition of anonymity because the order is not yet completed.

Trump also said he would issue an executive order to shield meat plants from legal liability if they are sued by employees who contract coronavirus while on the job. While Trump only mentioned Tyson Foods specifically, he suggested his order would protect other businesses from liability as well

Concerns about the nation’s meat supply have been growing, as the number of meatpacking facilities shuttered due to coronavirus outbreaks has accelerated over the past several weeks.

More than 4,400 meatpacking workers have tested positive for the virus, and at least 18 have died from the virus as of Tuesday morning, according to USA TODAY/Midwest Center for Investigative Reporting tracking. Workers have tested positive in at least 80 plants in 26 states, and there have been 28 closures of at least a day. 

USA TODAY also found that 153 of the nation’s largest meatpacking plants, about 1 in 3, operates in a county with a high rate of COVID-19 infection, raising concerns that more workers at more plants will fall ill.

The US has about 2,700 slaughter plants, 800 of which are federally inspected. In March, the country saw meat, beef and pork production reach record highs, according to the US Agriculture Department (USDA). The United Food and Commercial Workers International Union, which represents more than 250,000 meatpacking and food processing workers, said on Thursday at least 13 processing plants have closed over the past two months, resulting in a 25 percent reduction in pork slaughter capacity and 10 percent reduction in beef slaughter capacity.

Leprino Foods Shuts Dairy Food Plant Due to Virus

Operations halted Sunday at the Leprino Foods dairy foods processing plant in Fort Morgan, CO after a high number of employees, some without symptoms, tested positive for coronavirus, a plant spokesperson told CBS4. The plant will remain closed for a minimum of five days, according to Kim DeVigil. A reassessment is planned for Friday.

“We feel this extreme measure is necessary and important for the safety and health of our employees,” DeVigil said in a statement.

Aside from a complete cleaning of the facility, DeVigil said all remaining employees who have not been tested will undergo testing. Also, employees 65 years old and older will be held out of the workforce indefinitely. They will receive pay.

“It is important to note that sanitation and hygiene in our plant environments are robust on a normal basis,” DeVigil stated. “During the COVID-19 situation, we have further enhanced our sanitation processes and instituted a number of other protocols.”

When the plant restarts, employees will answer a questionnaire and receive temperature checks upon entering and be required to maintain social distancing once inside. All will be required to wear nose and mouth coverings as well.

DeVigil said Leprino will provide supplemental pay to workers forced out of the plant by due to coronavirus.

Leprino employs 350 people at the Fort Morgan location. The company’s website states it has produced dairy products since 1950 and is the largest producer of mozzarella cheese in the world.

According to DeVigil, the company initiated testing April 19th in partnership with the Northeast Colorado Health Department. Testing of the entire workforce is expected to be completed Monday. DeVigil said the company would share results of the testing when it has been completed and the data compiled

Air Showers are a Way to Reduce Virus in Locker Room Areas

Air showers are routinely used in cleanrooms.  They are located at the entry to the cleanroom but for healthcare personnel  can be located at the exit from  the healthcare environment to the locker room.

Converting Patient Rooms to Negative Pressure Isolation

Clean Rooms International, has successfully reconfigured and repurposed stock products to enable hospitals to convert standard patient rooms into negative pressure rooms for patient isolation.

"Healthcare systems are experiencing incredible pressure to accommodate growing numbers of patients impacted by the coronavirus," said Tim Werkema,  president and CEO of CRI.

"Customers came to us seeking a new way to quickly convert standard hospital rooms into negative pressure rooms for quarantine. In less than a week, our team of engineers repurposed dozens of units. In less than a month, we’ve shipped more than 1,000 from coast to coast. Due to the nature of the COVID 19 disease, which can be transmitted through respiratory droplets in the air, CRI engineers looked at its HEPA air filtration product inventory. Standard HEPA fan filter units were inverted and paired with exhaust systems or mounted to a small cradle with castors to create mobile units. The products are highly efficient in filtering and evacuating contaminants from the air. This creates a negative pressure environment, minimizing airborne contagions from entering hallways and corridors in a health facility."

As infection levels continue to rise, hospital systems will look for new and inventive ways to convert their facilities to meet patient needs,” said Bret Asper, Chief Operating Officer at CRI.

Mecart Providing Modular Isolation Rooms to Hospitals

Mecart is delivering critical isolation rooms to hospitals and healthcare facilities. As the coronavirus pandemic continues to spread globally, the need for dedicated treatment and patient space is increasing rapidly.

“Designing and building cleanrooms and clean-air environments is our core business, and one that we fully understand. We have the in-house engineering and manufacturing capacity to deliver solutions with short lead times to the Health sector. We will of course share our expertise in this critical time,” said Patrice Genois, Mecart’s Executive VP.

The addition of Mecart isolation rooms will drastically improve each hospital’s ability to serve its community during the current crisis. The rooms, which are available as modular structures or pre-assembled PODs, can be manufactured and delivered much more rapidly than standard construction.

Precision HVAC systems ensure that pathogens are contained, eliminating further spread of the virus while providing fresh air for patients and hospital staff. Post pandemic, these rooms can be reconfigured, moved and/or redeployed for a variety of other uses thanks to their complete independence from the host building.

Based in Quebec City, Mecart has been designing and manufacturing custom, modular cleanrooms for nearly five decades. The need for cleanrooms and clean environments spans many fields, from health-related applications such as pharmaceuticals, hazardous pharmacy compounding, research and clinical trials, to industrial uses in the electronics, aerospace and nanofabrication sectors.

Puracore COVID -19 Containment Modules Immediately Available

Thanks to their wholly independent operation, with engineering and manufacturing all completed in-house, medical isolation PODs are available to hospitals and healthcare facilities in under four weeks.

COVID-19 Containment modules/pods/rooms with the maximum size of 6 metres wide, and up to 4 metres high with an unlimited length. Which is easily cleaned with hygienic surfaces manufactured by Gilcrest’s specialist cleanroom division Puracore, Global Specialists in the Manufacture and Delivery of FM Approved, High Specification Cleanroom Systems. This enables a clean space for production in a controlled environment including converting non-sterile to sterile spaces and clean areas for equipment manufacture, in addition to COVID-19 human isolation areas and controlled environment for ventilator parts production.

We believe this is a simple cost effective and fast solution which is what is needed in this very challenging time. In addition, these can be expandable as demand grows and the containment modules are easy to relocate and reassemble with this in mind.

This product is available immediately and is part of Gilcrest Manufacturing’s commitment to deliver and meet all different types of demands.

• Standard unit 3 metres wide x 3.6 metres long x 2.4 high
• Max size up to 6 metres wide, up to 4 metres high, unlimited length
• Easily cleaned hygienic surfaces manufactured by a UK based specialist
• Easy to relocate and reassemble
• Clean space for production in a controlled environments including: Converting nonsterile to sterile spaces, Clean areas for equipment manufacture, COVID-19 human isolation areas, controlled environment for ventilator parts production
• Simple cost effective and fast solution
• Expandable as demand grows
• Available with sealed doors or strip curtains and pre fitted lights as required
• Worldwide shipping available

What Level of Filtration is Necessary?

With the coronavirus the medium and high risk areas are greatly expanded.  Here is the Camfil view on filter recommendations for each classification