Mann+Hummel has Acquired the Helsa Functional Coating Business from the Helsa Group

Swinburne University Develops Electrospun Carbon Nanofiber Mats

Pall Building New Breathing Filter Manufacturing Line

U.S. Sewing Automation Masks have PFE of 99.76%

LIGC Developing Electrostatically Charged Graphene Air Filter

Resistance to Reusing N95 Masks by Connecticut Nurses

Decontamination was Only Supposed to be A Stopgap Measure

Nurses in Connecticut do not Believe Masks can be Reused Many Times

Similar Objections have been Voiced in Multiple States

No Good Evidence that Masks can be Reused 20 Times

UV-C Light Effective in Decontaminating Masks in Michigan

_____________________________________________________________________________

Mann+Hummel has Acquired the Helsa Functional Coating Business from the Helsa Group

The acquisition expands Mann+Hummel’s product portfolio in active charcoal and molecular filtration.

“The takeover will enable Mann+Hummel to position itself as a technology leader in this growth market and further set the company up for the future. This is a further step towards achieving our vision “Leadership in filtration”, said Emese Weissenbacher, executive vice president and chief financial officer of Mann+Hummel.

“For us, as a niche provider of intelligent premium solutions in molecular air filtration, the takeover holds great potential,” said Norbert Gregor, CEO of Helsa Functional Coating and future Vice President & Managing Director of Molecular Filtration at Mann+Hummel.

 

Swinburne University Develops Electrospun Carbon Nanofiber Mats

Electrospun carbon nanofibre mats were formed from poly (acrylonitrile) by systematic stabilization and carbonization processes to generate flexible and self-standing membranes for air filtration. The great mechanical flexibility of the electrospun carbon-nanofibre membranes was achieved through extreme quenching conditions on a carbon fibre processing line, allowing for complete carbonization in just three minutes. The carbonized nanofibre membranes, with fibre diameters in the range of 218 to 565 nm exhibited modulus of elasticity around 277.5 MPa. The samples exhibited air filtration efficiencies in the range of 97.2 to 99.4% for aerosol particle in the size of 300 nm based on face velocity, higher than benchmark commercial glass fibre (GF) air filters. The carbonized electrospun nanofibre membranes also yielded excellent thermal stability withstanding temperatures up to 450 °C, thus supporting the development of autoclavable and recyclable membranes. This significant and scalable strategy provides opportunities to mass-produce reusable air filters suitable for otherwise complex airborne pollutants, including volatile organic carbons and bio-contaminants, such as viruses.

https://www.sciencedirect.com/science/article/abs/pii/S0048969720357600?via%3Dihub#!

 

Pall Building New Breathing Filter Manufacturing Line

The US Department of Defense (DoD) has awarded a contract to Pall Corporation for a new breathing filter manufacturing line.

The new line will be built at the company’s facility in the US to meet the demand of ventilator filters amid the coronavirus (Covid-19) pandemic.

Under the $4.9m valued contract, the new line will increase the production of ventilator filters from 485,000 units per month to 650,000 units per month.

The new line is expected to commence operations next year.

The DoD funding will support an increase in suppliers’ capacity for domestic ventilator critical components.

Pall Corporation and Danaher Group Executive president Jennifer Honeycutt said: “We are proud Pall was awarded this DoD contract, which allows us to increase the production of ventilator filters to help protect patients and give health care workers the equipment needed in a pandemic situation.”

Additionally, Pall’s lab solutions are supporting Covid-19 research and vaccine production processes.

Pall is a member of the Oxford University-led consortium working on developing an ‘effective Covid-19 vaccine’.

 

U.S. Sewing Automation Masks have PFE of 99.76%

United Sewing Automation, Inc. (USA) announced the test results of their ASTM Rated Level 3 Disposable PPE face masks produced in their new automated manufacturing facility in Mount Airy, N.C. With the continued spread of the Coronavirus, safety remains a top priority in America. While face masks have become a key component in fighting the spread of the virus, not all face masks provide optimal protection. As a result, USA recently completed extensive testing of their American-sourced and manufactured face masks in an ISO 17025 accredited laboratory and is pleased to report excellent results.

United Sewing Automation manufactures USA-sourced face masks in Mt. Airy, N.C.

ASTM International sets the preferred international standard in healthcare best practices inclusive of testing and requirements for performance of medical grade materials. The FDA, who oversees the sale and marketing of all surgical masks, requires that manufacturers demonstrate mask performance in several critical areas: Bacterial Filtration, Particulate Filtration, Liquid Barrier Protection, Breathability, and Flammability.

USA reported  the following test results:

·         BFE – ASTM 2101 Bacterial Filtration Efficiency – passed at 99.62%

·         PFE – ASTM F2299 Particulate Filtration Efficiency – Rated Over 99.76%

·         Fluid resistance ASTM F1862 – passed at 160 mmHg

·         Flammability 16CFR 1610 – Passing Results for Class 1

·         Differential Pressure ASTM F2101-19 Breathability – Passed at 4.8 mm  

·         Biocompatibility – Non-cytotoxic and Non-irritating

With testing complete, USA's American-sourced and manufactured masks are now in compliance with the Berry Amendment and qualify for Department of Defense contracts.

USA's face masks feature a three-ply design with a built-in adjustable nose bridge and ear loops made of nylon and Spandex, providing a better fit than traditional disposable masks.

"We are very happy with the new test results," said Ben Webb, USA's CEO. "Our goal is to provide the highest-quality protective masks for every face in America every time one is needed. This virus is highly contagious and the American public needs to better understand that not all masks provide the proper protection. These test results prove that our masks provide a higher level of protection than lower-quality, imported masks. We want to do our part in controlling the spread of this highly contagious airborne virus."

USA's ownership team has many years of experience in the textile and apparel industry and had the vision in 2017 to bring apparel manufacturing back to Mount Airy, N.C. through automation. USA recently installed high-tech Ultrasonic welding machines and automated production equipment capable of producing 1,000,000+ facemasks per week, with the ability to expand to meet market demand.

LIGC Developing Electrostatically Charged Graphene Air Filter

 

Israeli startup LIGC has raised $3 million in funding to build an air filter that uses an electric current and a material called graphene to zap germs and air impurities.

The funding comes from China’s publicly traded Hubei Forbon Technology, which makes air filters. LIGC plans to use the money to manufacture laser-induced graphene filters, which can be used in air filters.

LIGC CEO Yehuda Borenstein said he licensed the technology from Houston’s Rice University, in partnership with Ben Gurion University

 

Resistance to Reusing N95 Masks by Connecticut Nurses

John Brady, a registered nurse and vice president of AFT Connecticut, spelled it out a few weeks ago: “If we had enacted the Defense Production Act in the beginning, we would have all the PPE we need now. We can put a man on the moon – we can make PPE.”

Brady’s comment came during an interview about concerns voiced by registered nurses in Connecticut and around the country throughout the coronavirus pandemic about the shortage of new N95 masks and personal protective equipment in the United States.

Last week’s COVID-19 outbreak at Backus Hospital in Norwich – which infected at least nine hospital staff members – served as a Labor Day weekend reminder that our frontline healthcare workers continue to face a heightened risk of infection.

The Day of New London reported that the outbreak at Backus Hospital followed an earlier one at Three Rivers Healthcare, a Norwich nursing home where 21 people were infected and three people died of the virus. The state Department of Public Health is investigating how the outbreak occurred.

Hartford Healthcare, which owns Backus Hospital, attributed the outbreak to the inadequate use of PPE.

“Backus Hospital has identified an individual lapse in inappropriate use of PPE,” Dr. Ajay Kumar, Hartford HealthCare’s chief clinical officer, said in a statement, referring to the personal protective equipment doctors, nurses and other health care workers wear when treating COVID-19 patients and others. “Backus Hospital immediately addressed the lapse, conducted contact tracing and performed COVID-19 testing following its standard response plan. Any potential exposure has been contained and Backus Hospital is operating as usual.”

Before the pandemic, N95 masks were designated only for single use and were to be discarded immediately – even after only leaving a hospital room – in order to avoid cross contamination. But it quickly became clear that there would not be enough PPE to handle surges in cases.

On Feb. 4, the Centers for Disease Control and Prevention changed its guidance on PPE usage when the Health and Human Services Secretary authorized emergency use of additional respiratory protective devices in health care settings. The guidance was updated April 2 to explain that the use of PPE would depend largely on a hospital’s capacity and supply. The guidance has not changed since.

Months later, and despite what you may hear from leaders at the state and federal levels, frontline healthcare workers say PPE supplies are still low, and they are fed up with the lack of progress toward increasing that supply in order to get back to using things like N95 masks the way they were designed to be used – once per visit with a patient.

 

Decontamination was Only Supposed to be A Stopgap Measure

One of the ways the federal government tried to stretch PPE supplies was by awarding a six-month, $415 million contract to Battelle, an Ohio-based company that developed a controversial decontamination system for N95 masks. The company said their system, which had not received a standard Food and Drug Administration approval but instead was given a temporary emergency authorization, could clean masks for up to 20 uses.

The Department of Defense hired Battelle to set up 60 decontamination facilities throughout the country. One of those is on Chapel Street in New Haven.

U.S. Sen. Chris Murphy, a Democrat who has been vocal with his criticism of the Trump administration, says decontamination of the masks was only envisioned as a stopgap measure based on the urgency to preserve mask supplies in the early months of the pandemic.

It’s why he and U.S. Sen. Tammy Baldwin introduced legislation months ago to force the federal government to take over the supply chain for PPE and testing materials.

“If you’re talking about handing out masks on a daily or near-daily basis to every single school child in this country starting in the fall, we don’t have the capability to produce that number right now,” Murphy said in July. “We’re going to have to dramatically upscale.”

The Defense Production Act allows the federal government, in national emergencies, to require private manufacturers to manufacture specific items like N95 masks.

Murphy said there’s no lack of manufacturers in Connecticut and across the country that would be willing to switch their manufacturing process if the federal government was offering a contract.

But that hasn’t happened and in June, Battelle’s six-month authorization of use was extended by the FDA.

The New Haven facility was the seventh that Battelle set up, and when it launched in April it had already signed on nearly 40 hospitals and health care facilities in Connecticut, New York, Rhode Island, and Massachusetts.

Battelle workers pick up used N95 respirator masks from the hospitals and transport them to the Chapel Street facility where the masks are then placed inside large decontamination units. The units are subsequently filled with vaporized hydrogen peroxide, and the masks stay in that solution for roughly two-and-a-half hours.

Then Battelle workers de-gas the chamber, let the masks dry, and redistribute them to the original hospitals. Bags of decontaminated N95 masks are arriving at hospitals around the state for use by staff, as well as by members of the public who come in for care or with a loved one.

According to the FDA authorization, the masks must be labeled and the risk of using them is deemed to “outweigh the known and potential risks of such product.”

Battelle has said N95 masks can withstand the decontamination process up to 20 times without losing their ability to filter out viral particles, but some in the health care profession have their doubts.

 

Nurses in Connecticut do not Believe Masks can be Reused Many Times

At least one Connecticut nurse, who spoke on the condition of anonymity out of fear of retribution from their employer, doesn’t want to take that risk, suggesting that a clean mask is not necessarily a safe mask.

“We’re all in a field test without signing or agreeing to anything,” the nurse said, adding that decontamination was only one factor. “It is a cleaning method. It cannot maintain a mask’s constitution. Once the integrity of a mask is lost they are ineffective to block viral contaminants. The humidity of breathing, CO2 build up, oils from a person’s face, and wear and tear also take their toll on a mask, breaking down protective filtration fibers and reducing a tight fit seal along the edges.”

The nurse continued: “Decontamination methods aside, the very wearing of a mask reduces its integrity and degrades its efficacy. That was an established fact pre-pandemic and it remains a fact. The reality of the science doesn’t change just because we are desperate and short on supplies.”

 

Similar Objections have been Voiced in Multiple States

NBC reported that nurses and scientists from around the country have said that the masks begin to degrade after two or three decontaminations by Battelle, rather than 20, and the company’s own recent field testing only confirmed the integrity of the masks for four cycles of use and decontamination.

In June, the Massachusetts Nurses Association and a national nurses group renewed their call for hospitals to stop cleaning and reusing masks, because they believe it puts them at risk of exposure to the virus.

Nurses also told NBC that the masks often don’t fit correctly after just a few decontaminations – and a bad fit means the mask is essentially useless as a protective device.

Brady, of AFT Connecticut, said his members have also reported that the masks have a strong chemical odor after decontamination. “We don’t know if that is safe,” he said, adding that his members say the masks’ elastic bands are easier to break after a decontamination.

Overall, though, Brady says he and his colleagues are frustrated that the PPE supply is still not back to pre-pandemic levels.

“The fact that we’re still doing this … is ridiculous,” Brady said, adding that before the pandemic, wearing the same PPE from one contagious patient’s room to another would have been a firing offense. “The fact that the president hasn’t used the Defense Production Act [to produce N95 masks and other PPE] is inexcusable.”

The House passed the HEROES Act in mid-May but the bill has yet to be approved by the Republican-led Senate, where it faces strong opposition.

Adam Steinberg, vice president of medical affairs for Hartford Hospital, said they are using the masks cleaned by Battelle on a “trial basis.” He declined to say how big the trial was.

“Like everything with COVID, we’re trying everything,” Steinberg said last month.

 

No Good Evidence that Masks can be Reused 20 Times

The FDA’s use authorization for the Battelle cleaning system is based on the company’s own 2016 study, which, according to Battelle, “simply reports visual inspections of masks” after various amounts of decontaminations. During that testing, the masks were placed on mannequins – rather than human faces – and their fit was visually inspected.

In response to questions about its technology, Battelle said its cleaning system is a new innovation and was “developed, built, tested, and validate[d] in March 2020.”

It was never widely used in any commercial manner before the COVID-19 pandemic.

“The CCDS research team performs don/doff on standard NIOSH [mannequin] head forms in between decontamination cycles to simulate the stresses on the straps that occur when the FFR [filtering facepiece respirator] is put on a person and when it is removed,” Battelle said.

Asked if the company had conducted any additional studies that included fit testing on actual humans, complete with a hood and bitter agent protocols, Battelle responded in the affirmative:

“Yes. Battelle obtained Institutional Review Board (IRB) approval to perform fit factor testing with human subjects. Samples of six different FFR (four from 3M and two from Moldex) were tested as part of this study, with samples having gone through three decontamination cycles. The overall conclusion from this study was that three cycles of decontamination did not adversely impact the fit performance of FFR.”

However, The Boston Globe reported in July that Richard Peltier, an environmental health scientist at the University of Massachusetts Amherst, had been awarded a grant by the National Science Foundation to test the efficacy of respirator masks following various
sterilization methods.

According to the Globe, Peltier had little trouble acquiring treated masks from other hospitals in the state and had so far tested masks decontaminated in five or six different ways. But his requests for Battelle-treated masks to Partners HealthCare — the largest health system in Massachusetts — had been rebuffed.

The Globe further reported that Battelle acknowledged that during its field testing with Massachusetts General Hospital — designed to assess the impact on form and fit from actual use — the company had only examined masks that had gone through four decontamination cycles. Despite the lower number of cycles — four instead of the 20 that the company had previously boasted — a Battelle spokeswoman said the results of that testing have been excellent.

But the Globe also reported that Peltier said that Battelle also had turned him down when he reached out about obtaining decontaminated masks for additional testing. Battelle spokeswoman Katy Delaney didn’t directly respond to a question from the Globe about why Battelle had declined to take part in the study.

https://www.ctnewsjunkie.com/archives/entry/20200907_ppe_a_crisis_within_a_crisis/

 

UV-C Light Effective in Decontaminating Masks in Michigan

Dermatology researchers at Henry Ford Health System, in collaboration with a team at the University of Michigan, have demonstrated that certain N95 respirators tainted with COVID-19 can be effectively and safely decontaminated for reuse using ultraviolet-C light (UV-C), a method commonly utilized for treating rare skin diseases.

Researchers say the outside and inside of the facemasks were decontaminated in a prototype phototherapy unit that dispenses a UV-C dosing level high enough to effectively kill the virus in less than two minutes while still preserving the facemask’s breathability, fit and overall integrity.

Of the five N95s used at Henry Ford and tested for the coronavirus in the study, the decontamination process worked best on two models – facepieces on 3M 1860 and Moldex 1511 and straps on 3M 8210 and Moldex 1511. The effects of the dosage varied on the other tested models and their straps, suggesting that the UV-C radiation can degrade them. Researchers say wiping the straps with ethanol before decontamination would likely be required as an additional disinfection step in the process to maximize the wearer’s safety.

Researchers emphasized that fit testing be required each time a disinfected facemask is returned for use or a new model is being worn for the first time.

The research, conducted in partnership with the University of Michigan, is published in the International Journal of Infectious Diseases.

“Our findings reveal a practical, and viable option should hospitals encounter shortages of N95s in the future,” says David Ozog, M.D., chair of Henry Ford’s Department of Dermatology in Detroit and the study’s lead author. “Using UV-C has been shown to be effective in killing other coronaviruses and the flu virus. We were able to replicate that sterilization effectiveness with COVID-19.”

Ozog stressed that facemask sterilization should only be used in severe shortages of N95s.

Testing of the N95s for decontamination was performed at U-M’s SARS-CoV-2 research lab in Ann Arbor.

“When Dr. Ozog approached us about helping to demonstrate the effectiveness of their UV sterilization procedure with live SARS-CoV-2 virus, we immediately agreed and understood that we could provide some confidence to their healthcare workers that this procedure was effective,” says Jonathan Sexton, Ph.D., assistant professor of Internal Medicine and director of the U-M Center for Drug Repurposing and a study co-author.

The research culminated the work of a team of dermatologists and researchers who have devoted more than 400 hours since the pandemic hit Michigan to investigating how phototherapy – a type of medical treatment used for treating certain skin conditions – could serve a role in the global health emergency. The Henry Ford team includes Henry Lim, M.D., and Iltefat Hamzavi, M.D., both of whom are internationally recognized for their expertise using phototherapy for treating rare skin diseases like vitiligo and hidradenitis suppurativa.

The team’s focus centered on the potential of decontamination contaminated N95s for reuse by healthcare workers. They examined the reliability of the prototype unit and ultraviolet light, the minimum dosage needed for decontamination, the importance of fit testing post-decontamination, and four common methods associated with facemask decontamination.

The pandemic exposed a critical flaw in the global PPE supply chain as the health care industry struggled to obtain supplies of N95s, other facemask types, gowns, gloves, and face shields. As a result, decontaminating N95s to be reused safely became essential for many health care systems and providers until new shipments of supplies arrived. Henry Ford decontaminated thousands of N95s and returned them to their user for reuse in the first couple of months of the pandemic.

“The beginning of the pandemic was physically and mentally overwhelming for everyone. We desperately wanted to help our front-line workers, who were crushed with COVID-19 cases at Henry Ford,” Dr. Ozog says.

UV-C is one of the four methods considered for facemask decontamination. It is well known for its ability to penetrate the DNA of bacteria and microorganisms and prevent them from multiplying or replicating. Previous research has shown UV-C to be effective at killing the flu virus as well as two other well-known coronaviruses: severe acute respiratory syndrome (SARS-CoV) and the Middle East respiratory syndrome (MERS-CoV). Whether it could work on the novel COVID-19 virus was previously unknown.

Henry Ford’s phototherapy unit was modified with the help of engineers at Daavlin Co., a phototherapy manufacturer based in Bryan, Ohio. It sits on a flat surface and is about five feet long. The decontamination field measures 15 inches deep by 45 inches long – plenty of room to treat up to 27 facemasks at one time. The ultraviolet light is powered by at least 10 but not more than 20 UV-C lamps.

For the study, five types of N95s used at Henry Ford were tested at the U-M BSL3 biosafety lab. The respirators were contaminated with four drops of the COVID-19 virus taken from viral stocks obtained from the federal government’s Biodefense and Emergency Infections Research Resources Repository. The virus droplets were placed in four areas: nosepiece, apex, chin, and strap.

The facemasks were kept dry in a biosafety cabinet at room temperature for 40 minutes. Then they were moved to the phototherapy unit for decontamination using a dose of 1.5 J/cm2 ultraviolet light radiation – at a wavelength of 254 nanometers – to each side of the mask for about 60 seconds. Ultraviolet radiation is measured in three wavelengths: UV-C, UV-B, and UV-A. UV-B and UV-A are associated with skin cancer and are also used in the treatment of some dermatologic diseases such as vitiligo and psoriasis.

Indermeet Kohli, Ph.D, a Henry Ford dermatology physicist, developed a formula by which the UV-C dose delivered to the exterior and interior parts of the facemasks can be assessed for decontamination and safe use. She says the curvature of the facemask and the distance between its surface and the lamps are crucial factors in achieving the proper dosage.

“It is imperative that this type of assessment be performed to make sure that the decontamination process is done properly,” Dr. Kohli says. “Failure to do so could result in catastrophic consequences for front-line healthcare workers.”

The effectiveness of decontamination was measured in analytical chemistry terms by the limit of detection (LOD) and no cytopathic effect (CPE). LOD is the minimum concentration of a component that can be reliably detected. CPE means the virus yielded no infectious properties.

All five facepieces had below LOD and no CPE but some had traces of the virus on their straps, according to the research.

Researchers cautioned that none of the N95s tested were visibly soiled. Most health systems including Henry Ford prohibit the reuse of soiled N95s.

In a Letter to the Editor published in Photodermatology, Photoimmunology & Photomedicine, Shanthi Narla, M.D., a Henry Ford dermatology fellow, urged caution about using UV-C decontamination due to the variety of N95s in use across the country. “This process should only be considered as a risk mitigation effort during severe shortages,” she wrote.

In a demonstration of the prototype unit, the facemasks are placed on a stainless-steel tray, separated by autoclave tape to keep them from touching each other. Once one side of the facemask is treated, it’s flipped over to perform separate decontamination. Researchers say any visibly soiled masks should not be treated but rather properly disposed of as medical waste.

“Considering that many healthcare providers are using substitutes for N95s that offer a very limited degree of protection, using (UV-C) and repurposing phototherapy devices could be the best practical solution at this time,” Dr. Hamzavi wrote in Letter to the Editor published online in JAAD.

Researchers stressed that not all N95s are created equal and may not withstand decontamination. Degrading may occur in the facemask’s outer surface and the elasticity of the bands. Thus, researchers underscored the importance of fit-testing after decontamination in a study published in the Journal of the American Academy of Dermatology. Health care workers are fit-tested every year with their N95 to ensure a proper fit and no air can penetrate the outer edges.

UV-C is one of the four common methods used in health care to sterilize N95s. Hydrogen peroxide vaporization, microwave generated steaming and dry heating also have shown to be effective in varying degrees. UV-C and HPV are also commonly used for disinfecting patient care units, surgical suites, and intensive care units in the health care setting. Only the UV-C method was used in the Henry Ford study.

Researchers strike a cautionary tone for N95 decontamination no matter the method.

“Given the current COVID-19 pandemic, extreme measures are needed to keep those on the front line protected,” says Angela Torres, M.D., a Henry Ford dermatology fellow and lead author in a study published online in Photochemical & Photobiological Sciences. “These options are cost-effective, quick to employ, and have the potential to save many lives and valuable resources.”

However, Dr. Torres says, discarding a contaminated disposable N95 after a single use is “still ideal.”

https://bioscholar.com/2020/09/uv-c-light-could-kill-covid-19-on-n95-masks/